On-site ePRO in Action: A Recap of Castor’s Product Spotlight

September 23rd, 2025 by

Remote desktop and mobile ePRO has been in Castor for years, but in more recent customer conversations, one ask kept coming up: can we extend our current assessment solution to a controlled, on‑site setting?

 

And that’s what we built. We extended that remote functionality into our core platform for clinicians to access directly. So they can capture participant data in-person while staying aligned with the flexibility and compliance of remote ePRO.

 

Our recent Product Spotlight with our product experts Christian (Product Manager) and Dualtagh (Manager Solutions Consulting) detailed exactly how the solution works. But in case you missed it or would like a recap, below is an overview.

 

Flexible data capture for sites and patients

 

We designed our on-site ePRO to reduce burden on sites without the reliance on hardware. The functionality is modular to our existing ePRO solution. It doesn’t require an extra app or device, and entries flow into your CDMS alongside your other ePRO data.

 

After starting the on-site session, staff can hand over their device or display a QR code for the participant to continue on theirs. If time in the clinic runs short, progress is saved and the participant can finish up remotely—no duplicate records, no re‑entry. You can switch modes at any time and preserve progress.

 

“The whole point is that there are different completion options with our on-site ePRO. We know that sites often have a pile of devices at study sites,” Christian explains. “Crucially, our solution is device agnostic. It ultimately scales and flexes to the device that you’re using and that you already have rather than adding yet another thing to that pile of devices at your site.”

 

For studies

 
Our On-site ePRO allows for direct and enhanced data capture on the site at FPI. Collecting those ePROs on site at baseline ultimately results in fewer gaps before intervention. 
 

“Missing, inconsistent, or poor quality ePRO data—particularly at baseline—ultimately jeopardizes trial endpoints,” Christian recognizes. “And we all want to avoid that ‘missed data on the patient clipboard in the lobby syndrome’ where they get given the clipboard, enter only parts of the data, they then leave, and have to then come back or be brought back at another point to enter that data.”

 

For patients

 

If a participant prefers their own device—even in a controlled site environment—we let them use their own device. Participants choose what’s comfortable in the moment—clinic device or their own—while keeping the option to finish later without starting over.

 

“It’s much more flexible, it’s kind of part of that broader level of support for decentralized and hybrid trials—complementing the remote data capture and creating that seamless data continuum,” Christian says. “So no matter where they are, no matter what devices they have, no matter what point in the trial they’re at, we can still capture that data safely, securely, and consistently.”

 

For data managers

 

On-site ePRO ultimately ensures standardized capture under controlled conditions, improving reliability for regulatory review. Which in turn, improves the overall compliance tracking. Sites can immediately verify data entry, reduce lag, reduce dropout, and have the data sit alongside all of the other data in the same, consistent, compliance report.

 

Christian concludes, “I think one of the biggest benefits of the module is how wonderfully simple it is. It kinda just works, and leverages our existing assessment technology.”

 

How it works

 

As a site user, you can access the solution via a button in the existing platform, opening up a link in the browser that you can bookmark, or add as an icon on your tablet.

 

After opening the module, you’ll log in and be presented with the on-site administration page, where you select the participant, visit, questionnaire and the participant’s language. Next you’ll verify the participant’s identity and select how to administer the survey.

 

You’ll be presented with two options: 

 

Using the site device

 

Using the site device as a participant, you’ll be presented with a clean and simple interface. You can start navigating through the questions and a progress bar on the left will provide you with an indication of the completion percentage. 

 

“While I’m completing the survey as a participant, that data is auto saving immediately,” Dualtagh explains. “It’s syncing back with the participant’s record within our overarching CDMS. So it’s making sure that data is immediately available for the site to review as well. At the site, and against the record.”

 

When the participant is finished, they confirm that they’ve completed their responses and will be presented instructions around returning the device. When they confirm and hand the device back, the site user will be logged out to prevent the participant from seeing any information.

 

The site user can then log back in and will be taken to the administration page again, where they can select the next participant and move forward.

 

Using the participant’s device

 

When using the participant’s own device, they’ll scan the QR code presented on the site device. 

 

Just like with the site device, the participant is presented with a clean and simple interface they can navigate through, and the data is auto saving and syncing back to their record.

 

“It’s just another way in which we can provide that little bit of extra flexibility, for data capturing scenarios where you don’t have that site-based device available,” Dualtagh highlights.

 

Using remote back up

 

When you make use of any of our remote back-up options, the participant will be emailed a link to the questionnaire where they can pick up where they left off.

 

Tracking compliance

 

Within our CDMS, the compliance dashboard gives you a quick overview of the overall compliance across participants in the study. You can use filters to drill down into the compliance in the last 7 days, 30 days, or all time; or, for example, hiding the 100% compliance entries.

 

You can use more detailed filters to drill down into data, for example based on specific site statuses, or a compliance percentage window.

 

You can also have a look at the specific surveys that have been sent, and dig into the participants to follow up with to ensure good compliance across your study.

 

“And this really just goes alongside some of our broader functionality for patient reported outcomes,” Dualtagh says. “It sits nicely alongside things like our patient reminders and different notifications for different modalities. So, the ability to remind patients via SMS, via web, via WhatsApp, and these different means to keep them engaged.”

 

Find out more about Castor’s On-site ePRO

 

Want to know more? We’re happy to answer questions or get you set up.

 

For existing customers, studies, and researchers:

 

The On-site ePRO module can be activated by your account manager. Contact them directly or email [email protected].

 

For new customers, studies, and researchers:

 

Contact the Castor team here to get started with Castor ePRO, or email [email protected].

 

Of course, you can also watch the webinar here. 

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Today’s Challenges for Digital Therapeutics

January 5th, 2022 by

DTx growth transcends old barriers, presents new challenges

Recent years have seen transformative technological advances—pushed partly by the urgency generated from the COVID-19 pandemic. The need to evolve has affected many industries, Digital Therapeutics (DTx) included.1 DTx manufacturers face fresh challenges in completing clinical trials and commercializing their products. Thankfully, with careful planning and help from the right allies, DTx manufacturers can successfully adapt.

todays-challenges-in-digital-therapeutics

DTx are evidence-based software programs that allow patients and (remotely) their care teams to prevent, manage, or treat a medical disorder or disease.2 DTx usually focus on chronic and behavior-modifiable conditions—everything from diabetes to insomnia to substance use disorders. DTx push the boundaries on what is possible when healthcare meets tech. For example, Renovia’s FDA-approved leva® provides potentially more effective relief than traditional interventions for chronic fecal incontinence.3 Like other medical interventions, such as medications and medical devices, DTx undergo rigorous testing for approval and use.  

DTx market expanding

Grand View Research’s recent report on the DTx market projects expansion at an astonishing 23.1% compound annual growth rate from 2021 to 2028. The following factors can explain this growth:4

  1. As awareness of DTx grows, patients, providers, and payers are now accepting them as valid treatment options.
  2. The pandemic has highlighted humanity’s need for mental health services and convenient and accessible digital health solutions. 
  3. Pandemic-generated urgency changed the pace of regulatory approval. Regulation requirements were suddenly widened to accommodate new and higher-tech approaches to research and medicine. Revisions may speed up the overall regulatory support for next-generation medicine. 
  4. Increased smartphone usage across the globe means more access to DTx and remote healthcare.    

Emerging challenges

New challenges have replaced previous woes despite growing acceptance and the healthcare industry’s increasing demand for DTx. In May 2021, Castor interviewed Chris Bergman, president of Amalgam Rx, about his thoughts on the future of DTx. Bergman identified previous issues as lack of funding, regulatory ambiguity, and a hesitant market. Current issues, according to Bergman, have shifted to establishing evidence, creating adequate payment and business models, and effectively increasing distribution and scale. A few years ago, DTx were scrambling to navigate regulations and establish themselves as valid healthcare options. Today they are making changes to improve growth and prove efficacy.5

Planning for new challenges

DTx manufacturers can meet today’s challenges through careful planning during the development stage. According to Bergman, DTx manufacturers do well to consider the following before commercializing their products:

Another way to meet new challenges is through strategic alliances. Data management platforms, such as Castor, can fill gaps in DTx manufacturers’ experience in trial development, security, and management. Utilizing innovative tech in clinical trials saves time and money, protects patients’ data, and contributes to trial success—a must in today’s healthcare scene.

The COVID-19 pandemic brought unforeseen changes to the DTx market. Initial challenges such as payer adoption, patient acceptance, and (even) regulatory ambiguities no longer stand at the forefront of challenges for DTx manufacturers. Instead, manufacturers have to deal with how to prove efficacy and ensure product distribution at scale with proper reimbursement. Investing in trial tech, such as Castor products, will help DTx manufacturers meet these challenges. 

 

1Llopis G. Digital Therapeutics are accelerating personalization in healthcare. Forbes. https://www.forbes.com/sites/glennllopis/2020/08/09/digital-therapeutics-are-accelerating–personalization-in-healthcare/?sh=34001c2c2176. Published August 9, 2020. Accessed September 3, 2021.
2Understanding DTx. Digital Therapeutics Alliance. https://dtxalliance.org/understanding-dtx. Accessed August 26, 2021.
3Renovia. October 29, 2021. Renovia receives Breakthrough Device Designation for leva® Digital Therapeutic as first-line treatment for chronic fecal incontinence [press release].
4Digital Therapeutics market size & trends report, 2021-2028. Grand View Research. https://www.grandviewresearch.com/industry-analysis/digital-therapeutics-market. Published April 2021. Accessed September 3, 2021.
5The future of digital therapeutics and the impact on care. Linus https://www.thelinusgroup.com/blog/digital-therapeutics. Accessed September 3, 2021.

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Electronic Patient Reported Outcome (ePRO) Measures: Questionnaires & More

November 10th, 2020 by

Patient reported outcome measures in clinical trials have traditionally been done on paper. Surveys are a common way to collect data from study participants. Surveys are questionnaires that allow data to be collected from a predefined sample in a population [1].

Electronic Patient Reported Outcome Measures Man Using Questionnaire on Mobile Device

What are patient reported outcome measures?

Patient reported outcome measures, or PROMs, are an easy method for measuring a patient’s health status or health-related quality of life. These capture data from moments in time through medical questionnaires which patients complete independently [2].  

By filling in the questionnaires, patients directly report on how their symptoms, daily functioning and general well-being are perceived during the study. Therefore, PROMs ensure to record not only the researcher’s observations and interpretation but the patients’ perspective on their own health.

Why are patient reported outcomes important?

The broad goal of clinical trials is to improve healthcare and its outcome for the population. By collecting patient reported outcome data, researchers get a brief insight into the frequency and variety of symptoms as well as the disease’s actual impact on daily life. These findings can later be used to close the gap between clinical research and therapy to ensure a patient-centered and high-quality care practice

In the past, surveys have been administered on paper, which requires tedious administration and logistics, and can also pose a private health information security risk. Thanks to advancement in digital technology, it is now possible for researchers to easily collect data electronically and in a secure way using tools like ePROs (electronic Patient Reported Outcomes) or eCOA. Patients can complete secure electronic surveys sent via email, saving time, increasing engagement, and requiring less administration. At the moment, more than 26% of studies in Castor are using surveys.

electronic Patient reported outcome measurements

Benefits of eCOA / ePRO

  1. Electronic medical questionnaires are easy to distribute:

    A major benefit is a more efficient and streamlined workflow, equating to time saved for researchers and participants. Often, for example, travel time to the clinic for data collection can be a barrier for participants and negatively impact the study, especially when researching rare diseases or small gene pools [3].However researchers should use tools designed and built for medical research, both for security and data compliance.

  2. Electronic Surveys are cost effective, requiring minimal research power to reach people and collect data.

    With the correct electronic data capture (EDC) tool, researchers can send patient questionnaires directly from the system and do not need to import or copy data from paper. Well designed surveys will collect high quality relevant research data, but require careful crafting and evaluation of wording and questions [4].

As discussed above, medical questionnaires need to be well crafted to ensure they are valid and reliable. It is also important to ensure that the correct population sample is selected. As with all study designs, surveys can introduce bias as a result of poor responses or no-responses (researchers’ cognitive bias).

How to create good clinical outcome assessments

epro-patient-surveys-castor

As researchers, the challenging task lies in creating a well designed patient questionnaire that measures what it claims to measure ensuring that it is valid. External validity is important for the generalizability of the study, ie. are the inclusion or exclusion criteria properly defined, can the results be applied to a population [4]. And internal validity is related to the robustness of the study, ie. does it have sufficient statistical power, proper control groups, randomization and blinding necessary for clinical trial research [4]. And a reliable questionnaire that will produce consistent results upon repetition [1].

When generating a patient questionnaire, the questions can be close-ended or open-ended. With close-ended questions, researchers set the range of answers on a scale or a range of tick-boxes [1]. Open-ended questions or free text can enrich quantitative data, and researchers will want to plan in advance how this data will be analyzed [1].

Standardized questionnaires can also be used, see an example below of an EQ-5D Questionnaire from Kieran Bond of Aridhia [2]. These widely used forms ensure that a high level of validity and reliability is achieved throughout the research.

Example of an EQ-5D Questionnaire in Castor EDC
Example of an EQ-5D Questionnaire in Castor EDC

These widely used forms ensure that a high level of validity and reliability is achieved throughout the research.

Using Castor eCOA / ePRO to send medical questionnaires to patients

With Castor eCOA / ePRO you can create complex surveys in minutes, using more than 21 field types, pre-built templates, and validations. You can also reduce time spent on rebuilding surveys from scratch by reusing existing surveys.

You can choose from tried and tested electronic surveys shared by Castor users in the Castor Form Exchange. Standardized forms, for example, those that measure quality of life, can be easily downloaded and re-used.

By using Castor’s automation engine you can increase participant enrollment, retention, and experience through automated patient engagement. You can also easily manage survey participants through bulk invites, automatic triggers, and a dynamic dashboard.

Researchers can schedule surveys and create emailing schedules to distribute patient questionnaires on certain dates or according to a custom timeline.

 

Using encrypted email addresses, clinical data entry is combined with outbound survey invitations sent to study participants. And at the push of a button, researchers can send a clinical outcome assessment to hundreds of participants, monitor its status and see results directly in the study dashboard.


Check out our webinar on how to build surveys in Castor eCOA / ePRO.

 

 

Sources:

  1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC420179/
  2. http://www.aridhia.com/blog/building-trust-and-improving-participation-in-clinical-trials-using-innovative-electronic-data-capture-platforms/
  3. http://www.bmj.com/content/350/bmj.g7818
  4. https://www.bmj.com/about-bmj/resources-authors/article-types

 

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Castor Is Committed to Scalable FAIR Data

October 1st, 2018 by

Success in life sciences research is all about transforming research findings into actionable knowledge. In this context, FAIR stands for Findable, Accessible, Interoperable and Reusable data, four critical elements to improve research infrastructure, making it easier for researchers to collaborate, ultimately improving the quality of healthcare in general.

#FAIRdata is a key topic at The Dutch Techcentre for Life Sciences (DTL)’s 2018 Conference, which we are proud to support. DTL provides a helpful description of each of the four elements on their website:

Findable – Data and metadata should be easy to locate, both by humans and by computer systems. Basic machine-readable descriptive metadata enable the discovery of interesting datasets and services.

Accessible – Stored for long term so that they can easily be accessed and/or downloaded with well-defined license and access conditions (open access when possible), whether at the level of metadata, or at the level of the actual data

Interoperable – Ready to be combined with other datasets by humans or computers

Reusable – Ready to be used for future research and to be further processed using computational methods

These FAIR principles are perfectly aligned with Castor’s goal of helping “accelerate medical research by unlocking the potential of every byte of research data.” 

Click here if you would like to learn more about the FAIR data specification.

Concerns over data quality and usability

Over the years, as an MD and a researcher myself, I have become more and more concerned about the quality and the (re-)usability of data. In fact, approximately 85% of medical research data is never re-used due to poor data quality, lack of standardization, and by the data being inaccessible to others. I started Castor EDC in 2012 to address these issues and was happy to learn about the FAIR principles, which were published in 2016. This, in addition to other important initiatives such as the European Open Science Cloud (EOSC), are fostering global data findability and accessibility.

Open Science is an umbrella term for new technologies and a data driven systemic change in how researchers work, collaborate, share ideas, disseminate and reuse results. It is built on a foundation of core values that knowledge should be reusable, modifiable and redistributable.

The Commission “High Level Expert Group European Open Science Cloud” chaired by Barend Mons has published a first report on how the EOSC can be realized.

You can learn more about DTL’s vision regarding Open Science here.

Incorporating FAIR principles into Castor EDC

At Castor, one of our main goals for the next few years is to become a pioneering player in the field of Open Science. This means we will prioritize the development of data FAIRification within Castor EDC. By allowing researchers to expose their Castor data in a FAIR manner, research data can be shared easily between research projects worldwide.

At the 2016 BYOD hackathon in Leiden, Netherlands, Castor’s CTO, Sebastiaan Knijnenburg, PhD, and I spent three days learning about the FAIR specifications and trying to implement them into Castor. In just three short days we managed to extend our API and transform Castor into a FAIR data point.

BYOD FAIR hackathon
Castor attending the 2016 “Bring Your Own Data (BYOD)” FAIR hackathon in Leiden, Netherlands.

We also managed to implement a Resource Description Framework (RDF) endpoint. We added semantic metadata to a Castor study and allowed the export of this study data in the RDF format. Two other software solution providers, OSSE (Open Source Registry System for Rare Diseases in the EU) and RDRF (Rare Disease Registry Framework) also worked on generating FAIR API endpoints for their software. (Learn more about medical device registry studies here.)

As a result, on the last day, data from a case study in all three systems could be queried and analyzed together, even though the original datasets were developed separately and did not share the similar structure.

Every dataset should be FAIR

In my view, every dataset in the world should become FAIR, not just those with funding to pay for FAIR data stewardship. This is why Castor is joining forces with several partners, such as DTL, that support Open Science to create an infrastructure that allows researchers to create semantic data models themselves. They can then actually create FAIR data at the source. Once we get this to work for all the studies in our system, FAIR will really start to shine. By enabling FAIR data at scale, researchers can easily make their clinical research data available for the FAIR research community. This way, both humans and computers will be able to search and filter through a dataset on a semantic level.

That said, semantic modeling is an area we can improve, as it is currently very labor intensive and can only be done with the help of experts. I have some ideas on making the creation of FAIR data accessible for everyone, and I will be working on these ideas in the coming years with FAIR scientists from across the globe.

Start small

As beautiful as fully interoperable, machine-readable data are, just the ability to find and access research data globally will make a big difference. Having the FAIR data points available, with a simple Comma Separated Value (CSV) download distribution for instance, will already be a big improvement in the short term.

The ultimate goal is user-created scalable content

We should work together towards enabling user-created scalable FAIR data. I think that would be the key to success. As soon as researchers start to realize the potential of FAIR –like the European Science Cloud– it will make a big difference in their attitude towards sharing data.

Furthermore, once people see the immense savings that a standardized data set can make, it could lead to initiatives that can contribute to making valuable medical data universally available.

Going forward

Showing the world how awesome user-created scalable FAIR data is and how useful it can be is a very important first step.

We at Castor have applied for grant funds to enable us to put more effort into working on scalable FAIR data and to demonstrate its overall benefits.

For additional background on Castor and our efforts to support FAIR data, here is a video completed for the 2016 FAIR hackathon:

 

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Castor joins forces with EuroQol to facilitate EQ-5D survey usage

June 27th, 2019 by

The EuroQol Research Foundation created EQ-5D to standardize how health-related measures such as Quality of Life and other healthcare evaluations are collected. This initiative is aligned with our quest to standardize medical research. And today, we are thrilled to announce that these EQ-5D modular versions are now available for Castor EDC users! 

Under this partnership,  Castor users can now make use of pre-made Castor EDC forms for the EQ-5D surveys. This simplifies the process of accessing and sending these surveys by eliminating the need for screenshot review by EuroQol.

The surveys are available in both Dutch and English, for EQ-5D-3L and EQ-5D-5L. Castor users can obtain these surveys by registering their studies on the EuroQOL website. For academic studies, Castor EDC’s EQ-5D modules can be used for free (after registration). For commercial studies, a license fee will be charged according to EuroQoL’s user policy.

A demo version of the Castor EQ-5D surveys can be found here. Give it a spin and tell us what you think!

Demo Request

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Bridging clinical efficacy and real-world effectiveness in digital therapeutics trials

January 25th, 2022 by

How real-world data capture closes the gap

No matter how conclusive clinical evidence is for medical treatments, developers may struggle to see precisely how their treatment performs in the real world—outside the controlled environment of the clinic or office. Do patients take the medication as expected while immersed in busy schedules? How often do they practice the exercises the therapist prescribes?

Unfortunately, medical treatments proven to work in clinical trials do not always measure up in the real world. According to Simon Makin’s “A smarter way to treat” article, one quarter to one half of the global population doesn’t take medications as recommended. In the U.S., this failure links to up to 125,000 deaths and costs up to $289 billion.1 The gap between efficacy and effectiveness is a significant issue impacting many.

Digital therapeutics provide real-world data capture

Enter digital therapeutics (DTx) and their unique ability to capture real-world data remotely. DTx are software-based, evidence-driven treatments for managing, preventing, and treating a wide range of medical conditions or illnesses.2 Unlike conventional medical interventions such as medications or medical devices, DTx can constantly gather data on patients’ involvement and progress—giving a crystal-clear view of how the treatment is working outside of a clinical setting.

bridging-clinical-efficacy-and-real-world-effectiveness-thumbnail

DTx capture data via software on patients’ devices or connected wearables. App data includes any biometrics recorded in the app, patient-reported outcomes, patient progress through software modules, and other data stored in the app, such as clinic visits and test results. While more traditional data collection methods are periodic, real-world data collection can be continuous and ongoing.3 When used effectively, the detail captured improves the data quality and helps demonstrate how users interact with the treatment in their everyday lives.4

These examples illustrate DTx real-world data capture:

Tech helps manage real-world data capture

Tech tools help DTx maximize the impact of the real-world data they capture. Technology can assist in every aspect of handling patient data—from collecting responses from digital patient surveys to capturing, processing, and integrating data from varied sources to securely tracking patients’ consent. Software developed specifically for DTx streamlines data capture and management, making it easier for DTx to get products to market and into patients’ hands. DTx real-world data capture can bridge the gap between how well researchers think their treatment functions (efficacy) and how well their treatment performs (effectiveness) outside of a clinical setting. Regular, remote data capture can transform how effective treatments can be and the type of people they can reach.

 

1Makin S. A smarter way to treat. Nature. 2019;573. https://media.nature.com/original/magazine-assets/d41586-019-02873-1/d41586-019-02873-1.pdf. Accessed August 27, 2021.
2Understanding DTx. Digital Therapeutics Alliance. https://dtxalliance.org/understanding-dtx. Accessed August 26, 2021.
3Sverdlov O, van Dam J, Hannesdottir K, and Thornton-Wells T. Digital therapeutics: An integral component of digital innovation in drug development. Clin Pharmacol Ther. 2018;104(1):72-80. doi:10.1002/cpt.1036
4Van Norman G. Decentralized clinical trials: The future of medical product development? JACC Basic Transl Sci. 2021;6(4):384–387. doi: 10.1016/j.jacbts.2021.01.011
5DTx product case study: Propeller. Digital Therapeutics Alliance. https://dtxalliance.org/products/propeller/. Accessed August 26, 2021.
6The Mabu care insights platform. Catalia Health. http://www.cataliahealth.com/platform-ai/. Accessed September 8, 2021.
7Patient-centered solutions. Catalia Health. http://www.cataliahealth.com/solutions/. Accessed September 8, 2021.

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A Digital-First Mindset Shift on eConsent

September 26th, 2023 by

eConsent plays a pivotal role in optimizing modern clinical trials, but the nuance around eConsent adoption for pharmaceutical and medical device companies remains a consideration for implementation teams. Castor CEO & Founder – Derk Arts MD, Ph.D. recently sat down with Leanne Walsh of Northern Light Lifescience to talk about the challenges, processes, considerations, and mindset shifts that study teams must consider when reviewing eConsent for their trials.

From the conversation between Derk and Leanne, as well as the audience Q&A, it’s clear that the question of eConsent isn’t so much of a “Why?” but a “Why not?” As one attendee noted, “This sounds like people [are] using eConsent in exactly the same way as paper though—in the clinic alongside a face-to-face conversation. If it is used as a tool to provide information to potential participants ahead of a clinic meeting or as a follow-up to the clinic, then it could add more value.”

Here are some of the key themes from the discussion:

eSignature vs. eConsent vs. Digital Signature: Are they the same?

The first barrier to eConsent adoption is getting over regulatory uncertainty. On the sponsor and site ends—especially in terms of signature use, misconceptions about “eConsent is only the eSignature” are still very prevalent. eConsent allows for additional sources of information that the participant can review ahead of time. All of this capacity is contained within the eConsent ecosystem and can happen before a visit to the site. Educating study designers and IRBs to understand that the informed consent process is its own ecosystem rather than just the signature element is a crucial step to break out the parts of eConsent that go well beyond just eSignature.

An electronic signature is always integral to eConsent. However, eSignature requirements vary by country, impacting eConsent adoption. In countries that do not accept eSignature, Castor’s research indicates that a participant can often sign a paper form while on the video call and then mail in that form. Although this method entails paperwork, you retain two key benefits: the eClinical platform tracks the consent status, and participants can access trial information online at any time.

“People’s perceptions are different right down to the basics around a signature and digital signature. Are they the same thing? And do they mean the same in the regulations from the FDA versus in Europe? Vendors should be responsible to convey what it means, clarify those terminologies, and make it simple for the study teams to understand.“

– Leanne Walsh, Director, Northern Light Lifescience

Read more from the FDA on Informed Consent for Clinical Trials. 

Digital vs. analog systems: Can eConsent enhance data retrieval over traditional paper processes?

The shift from analog to digital systems in the consenting process is not merely a trend but a necessity. Picture the traditional paper-based consenting process: physical folders, stacks of papers, and the ever-present risk of misplacing a crucial document. This analog approach, although familiar, presents challenges. As the volume of participants grows, so does the paperwork, leading to an increased risk of data loss.

Building on the insights from the webinar, there is an undeniable “wait and see” approach when it comes to adopting new technologies. This hesitancy is often rooted in the challenges of implementing features and the perceived complexities of digital systems.

But let’s debunk a myth: digital systems, especially in the consenting process, are designed to secure data storage. With everything stored electronically, data accessibility becomes seamless. If the study team needs to pull up a specific patient’s consent form, it is only a click away.

“What’s stopping sponsors from engineering their way into accessing clinical data is the concern that all the paper will get digitized in some shape or form and stored somewhere that is completely untraceable […] There’s no way a response would break into a digital system and override whatever access they have to. Then review data that they are not supposed to have access to. So I think it is unequivocally true that digital systems are actually safer and better in restricting access to information or giving access to the right information than analogue analog systems.“

– Derk Arts, CEO & Founder, Castor 

Shifting to a “digital first” mindset creates a larger move toward eConsent adoption among sponsors

The “digital first” approach not only highlights the safety and security benefits of eConsent over paper, it also helps study designers and IRBs experience the expanded capabilities of the whole eConsent ecosystem out in the open. Seeing the eConsent capabilities allows the clinical staff and study designers to plan for how to deliver the extra information that is customized to specific needs of participants.

Digital systems can enhance the patient experience by allowing researchers to develop tools that are more efficient, interactive, and personalized. They can give study participants enough flexibility and time to be better prepared for the consultation with clinicians, formulate questions, or use the waiting time efficiently if the tools are used in the waiting room.

However, the success of this approach hinges on timely adoption. By embracing the digital first mindset from the get-go, study teams can ensure that eConsent isn’t an afterthought but a foundational pillar of the study design. This proactive approach can catalyze conversations, ensuring that sponsors are aligned and onboard from the outset.

Watch the on-demand recording of eConsent from Sponsor to Site: Navigating Successful eConsent Adoption to take in the full conversation and hear about the impact of eConsent, real-world examples of eConsent evaluation, readiness, and implementation, and potential for future industry adoption. 

Discussion Highlights: 

 

Castor’s product suite ensures security, access, and ease of use for sponsors. Our ongoing innovations keep Castor software and technology poised to meet the expanding needs of clinical trials. Ready to learn more? Let’s chat.

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3 Ways eConsent Tackles the Challenges of Modern Clinical Trials

September 28th, 2021 by

Although eConsent struggled to gain momentum and wider acceptance pre-pandemic, it is actually powered by technology that is regularly used in daily life and is more approachable than one might think. Regardless, some researchers are still hesitant to embrace remote technology. In this article, we’ll explore three areas that researchers cite as obstacles when implementing eConsent: data safety; regulatory compliance; and identity verification. Read on to learn how these issues can be resolved safely and efficiently.

Playing it safe with data

Data integrity, safety, and privacy are of critical importance these days. And with good reason—never before has so much personal data been processed through online services. Since medical data is among the most private there is, clinical trials must adhere to the highest standards of data protection while offering their participants data privacy. Fortunately, there are several ways to accomplish this via  eConsent.

In order to keep data safe and secure, opt for an eConsent solution with:

When employing eConsent, investigators should use embedded HIPAA-compliant authorization forms to ensure FDA compliance. In the EU, the GDPR’s most recent guidance requires “an effective audit trail of how and when consent was given, so you can provide evidence if challenged” and “an appropriate cryptographic hash function to support data integrity.” 

Any video conferencing used as part of eConsent must be secure, traceable, and fully compliant. For example, it should be encrypted and US 21 CFR Part 11 compliant. 

Navigating the regulatory jungle

The regulatory jungle is complex enough to discourage researchers from changing established methods they know are fully compliant (or that they believe are fully compliant). . It doesn’t help that different countries and regions have their own regulations around the use of eConsent and acceptance of eSignatures. At the time of writing, the FDA’s most recent guidance was published in December 2016 and no EU regulation or guidance about eConsent in clinical trials exists.

Ensuring regulatory compliance is not hopeless, however. In general, Institutional Review Boards (IRBs) and ethics committee have consistent requirements for paper and electronic consent, such as:

Researchers need to familiarize themselves with their applicable IRB guidelines. (Find a handy overview of eConsent guidelines in twelve different countries here.) When making a submission for an eConsent-based study, it’s important to also address:

Checking IDs at the door

Clinical investigators need to confirm the identity of all participants in a trial according to regulatory requirements. But that doesn’t mean every participant needs to present themselves at the study site—video conferencing to the rescue!

An appropriate, secure video conferencing solution provides investigators with real-time, visual interaction with participants. This allows the study team to verify the identity and, if using a hybrid wet-signature with eConsent, witness the signature of each participant. But the benefits don’t end there—video conferencing allows a clinical researcher to answer questions directly, cementing trust with a participant and increasing retention. Importantly, investigators are able to observe the participant’s behavior and determine if they are capable of offering informed consent and are consenting of their own free will.

Castor eConsent is a flexible, user-friendly, and secure solution for your next trial. If you’re interested in learning more about putting eConsent to work in your next trial, reach out to one of our friendly Castorians here.

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EQ-5D in European Trials: When Generic QoL Measures Actually Matter

August 26th, 2025 by

Many European biotechs discover that FDA-focused PRO strategies overlook valuable reimbursement opportunities across European markets. Companies repositioning EQ-5D from “regulatory necessity” to “HTA advantage” often secure faster reimbursement approvals, while acknowledging that the same data contributes minimal value to FDA label claims.

This reality reflects the fundamental misalignment between vendor marketing and regulatory practice: EQ-5D’s value lies in European health technology assessment, not US regulatory acceptance.

The Regulatory Reality Check

Analysis of 735 FDA drug approvals found 0% included EQ-5D data in product labeling, while only 5% mentioned it in supporting documentation [Shaw et al. 2024]. Meanwhile, European Medicines Agency acceptance reached 5% for labeling support which is limited but measurably better than FDA’s complete resistance.

FDA‘s opposition to generic quality of life measures stems from fundamental concerns: generic instruments lack sensitivity to detect small therapeutic benefits and cannot distinguish treatment-specific adverse effects. Their preference for disease-specific PRO measures reflects regulatory pragmatism, not methodological bias.

Where EQ-5D Actually Succeeds

EQ-5D’s strength lies in European health technology assessment, not clinical outcome measurement:

German HTA Bodies: Analysis shows strong EQ-5D acceptance in German HTA processes, with IQWiG and G-BA demonstrating systematic usage when quality of life assessment is included [Shaw et al. 2024]. German bodies show notable acceptance for clinical outcome assessment among European regulators.

NICE Guidelines: NICE continues to recommend EQ-5D for cost-utility analysis while maintaining the 2019 position on EQ-5D-5L value sets, requiring mapping to 3L values for consistency [NICE 2019].

French HAS: Recognizes EQ-5D within their health economic evaluation methodology, though specific usage varies by therapeutic area and assessment context [HAS 2020].

Understanding EQ-5D’s Actual Structure

EQ-5D is a simple, 5-question static questionnaire. The instrument covers five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, plus the EQ-VAS rating overall health from 0-100.

No special site training or certification is required for standard administration. The 2-3 minute completion time reflects genuine simplicity, not algorithmic optimization. This simplicity explains both EQ-5D’s broad adoption and its regulatory limitations.

When EQ-5D Doesn’t Work

Avoid EQ-5D as primary strategy when:

  • FDA labeling claims are your primary objective (0% success rate)
  • Disease-specific outcome measurement is regulatory requirement
  • Ceiling effects are expected in your patient population
  • Sensitivity to small therapeutic benefits is crucial for approval

Implementation limitations to acknowledge:

  • Generic nature misses condition-specific improvements
  • Statistical analysis challenges affect many studies due to missing data and ceiling effects [Pickard et al. 2007]
  • No special training requirements means limited differentiation from competitor implementations

The Economic Reality

EQ-5D’s true value lies in quality-adjusted life year (QALY) calculations essential for European health technology assessment. The instrument provides standardized utility values across therapeutic areas, enabling cost-effectiveness analysis required by most European reimbursement bodies.

However, this economic value shouldn’t be confused with regulatory acceptance. Analysis shows clinical outcome assessment represents approximately 18% of EQ-5D usage in technology appraisals, with the majority focused on economic evaluation [Shaw et al. 2024].

Your Practical Implementation Plan

Immediate Assessment (This Week)

  1. Clarify regulatory objectives: Determine whether your primary need is FDA labeling, European regulatory support, or HTA economic modeling
  2. Review current PRO strategy: Assess whether disease-specific measures are already planned for regulatory endpoints
  3. Evaluate HTA requirements: Identify which European markets require QALY data for reimbursement decisions

Strategic Planning (Next 2-4 Weeks)

  1. HTA body consultation: Engage with NICE, G-BA, or relevant bodies on EQ-5D requirements for your therapeutic area
  2. Platform assessment: Ensure your clinical trial solutions support both EQ-5D data collection and economic analysis
  3. Budget allocation: Plan implementation costs focusing on health economic value rather than regulatory claims
  4. Timeline integration: Coordinate EQ-5D deployment with broader European market access strategy

Implementation Excellence (Following 12-22 Weeks)

  1. HTA-focused deployment: Prioritize data quality for economic modeling over regulatory claim support
  2. Country-specific optimization: Apply appropriate value sets and preference weights by market
  3. Economic analysis preparation: Generate QALY calculations supporting reimbursement submissions
  4. Realistic outcome measurement: Track HTA acceptance rates rather than regulatory approval metrics

Frequently Asked Questions

Why do vendors position EQ-5D as “regulatory accepted” if FDA acceptance is 0%?

Vendor marketing often conflates HTA acceptance with regulatory approval. While EQ-5D has established HTA positioning, particularly with NICE’s continued preference, this differs significantly from regulatory labeling acceptance. The distinction matters for setting realistic expectations and budget allocation.

Should I avoid EQ-5D entirely for US trials?

Not necessarily. EQ-5D can provide valuable health economic modeling data for US payers and HTA bodies like ICER. However, expect zero contribution to FDA labeling claims and plan disease-specific measures for regulatory endpoints.

How do I maximize EQ-5D’s value in European trials?

Focus on health economic evaluation rather than clinical outcome assessment. Ensure your platform supports QALY calculations with country-specific preference weights, and coordinate with HTA bodies early in protocol development.

What’s the most efficient EQ-5D implementation approach?

HTA-optimized implementation (12-16 weeks) provides the highest return on investment by focusing on EQ-5D’s established strengths rather than attempting to overcome its regulatory limitations.

References

[1] Shaw, J.W., et al. (2024). A Review of the Use of EQ-5D for Clinical Outcome Assessment in Health Technology Assessment, Regulatory Claims, and Published Literature. The Patient. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC11039499/

[2] Pickard, A.S., et al. (2007). Psychometric comparison of the standard EQ-5D to a 5 level version in cancer patients. Medical Care, 45(3), 259-263. Available at: https://pubmed.ncbi.nlm.nih.gov/17304084/

[3] Sampson, C. (2022). NICE and the EQ-5D-5L: Ten Years Trouble. PharmacoEconomics – Open, 6, 5-8. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC8807740/

[4] Ciani O, et al. (2023). The Assessment of Patient-Reported Outcomes for the Authorisation of Medicines in Europe: A Review of European Public Assessment Reports from 2017 to 2022. Pharmacoeconomics, 41(11), 1411-1426. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC10627987/

[5] NICE. (2019). Position Statement on Use of the EQ-5D-5L Value Set for England (updated October 2019). Available at: https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/technology-appraisal-guidance/eq-5d-5l

[6] Haute Autorité de Santé (HAS). (2020). Choices in Methods for Economic Evaluation. Available at: https://www.has-sante.fr/jcms/r_1499422/en/methodological-guide-for-health-economic-evaluation

[7] Devlin, N., et al. (2018). Valuing health-related quality of life: An EQ-5D-5L value set for England. Health Economics, 27(1), 7-22. Available at: https://pubmed.ncbi.nlm.nih.gov/28833869/

[8] Janssen, M.F., et al. (2013). Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups. Quality of Life Research, 22(7), 1717-1727. Available at: https://pubmed.ncbi.nlm.nih.gov/23184421/

[9] EuroQol Research Foundation. (2023). EQ-5D-5L User Guide. Available at: https://euroqol.org/information-and-support/euroqol-instruments/eq-5d-5l/

[10] FDA. (2024). Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Available at: https://www.fda.gov/media/77832/download

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ePRO, eCOA 101: Everything You Need to Know About ePRO and eCOA

July 31st, 2025 by

What is eCOA?

Electronic Clinical Outcome Assessment (eCOA) represents the digital transformation of patient outcome measurement in clinical trials. Rather than relying on traditional paper forms, eCOA technology encompasses all electronically captured clinical outcomes data, fundamentally changing how trials collect and manage patient-reported information.

The shift from paper to digital has revolutionized clinical trial data collection, creating new opportunities for real-time monitoring and improved data quality. Modern electronic data capture systems integrate with eCOA platforms to create comprehensive clinical data ecosystems supporting both regulatory submissions and real-world evidence generation.

Understanding ePRO Within the eCOA Framework

Electronic Patient Reported Outcomes (ePRO) represents the patient-centric component within the broader eCOA framework. While these terms are often used interchangeably, ePRO is actually one of four distinct assessment types within the eCOA ecosystem:

  • ePRO (electronic Patient Reported Outcomes): Patient-reported symptoms, quality of life measures, and treatment experiences
  • eClinRO (electronic Clinician Reported Outcomes): Healthcare provider assessments and clinical observations
  • eObsRO (electronic Observer Reported Outcomes): Caregiver or family member observations, particularly important in pediatric or cognitive studies
  • ePerfO (electronic Performance Outcomes): Objective measurements captured through digital tools and devices

ePRO has gained particular prominence in patient journey optimization due to its direct connection to patient experiences and regulatory emphasis on patient-centered drug development. Decentralized clinical trials increasingly rely on ePRO data to capture patient experiences outside traditional clinic settings.

The Implementation Reality: Beyond Technology

eCOA implementation involves significantly more complexity than deploying a simple electronic survey. The process requires careful coordination of regulatory compliance, intellectual property management, and operational planning across multiple stakeholders.

Regulatory Framework: Regulatory agencies continue emphasizing electronic data collection approaches in clinical trials, with updated guidance supporting eCOA implementation. The FDA defines Clinical Outcome Assessments as measures that describe or reflect “how a patient feels, functions, or survives,” encompassing the four eCOA categories [FDA 2024][1]. The industry has responded with remarkable growth – the global eCOA solutions market reached $1.94 billion in 2024 and is projected to grow at 16.1% annually to $4.78 billion by 2030 [MarketsandMarkets 2024][2].

Intellectual Property Management: Many clinical trials utilize copyrighted assessment instruments that require specific licensing agreements. These instruments often carry usage restrictions and approval processes that can significantly impact implementation timelines and platform selection decisions.

System Integration Requirements: eCOA platforms must integrate with existing clinical trial infrastructure including EDC systems, clinical trial management systems, and regulatory submission processes. This integration requires sophisticated technical architectures and security protocols that meet clinical research standards.

Data Integrity and Compliance: Clinical trials require comprehensive audit trails, electronic signatures, and data lineage capabilities that support regulatory inspections. Organizations must ensure their eCOA platforms integrate with electronic consent processes and maintain data integrity throughout the study lifecycle.

BYOD vs. Provisioned Devices: Strategic Considerations

The choice between Bring Your Own Device (BYOD) and sponsor-provisioned device strategies represents a critical implementation decision with implications for patient experience, data quality, and operational complexity.

Provisioned Device Approach

Sponsor-supplied devices offer controlled environments with standardized hardware, operating systems, and security configurations. This approach provides consistency across all participants but introduces logistical challenges including device distribution, technical support, and patient training requirements.

BYOD Strategy Considerations

BYOD approaches leverage patients’ existing smartphones and tablets, potentially improving engagement through familiar interfaces and integration into daily routines. However, BYOD implementation requires careful attention to device variability, security protocols, and data equivalency validation across different platforms and operating systems.

BYOD adoption is accelerating rapidly, driven by cost-effectiveness and patient familiarity with personal devices. Research demonstrates the importance of patient-centered design and user experience for successful eCOA implementation, with electronic methods showing superior compliance compared to traditional paper-based approaches [Clinical Leader 2024][3]. Organizations considering BYOD strategies should evaluate current regulatory expectations and validation requirements for their specific study contexts.

Licensing and Validation Considerations

Copyright and licensing management represents one of the most complex aspects of commercial eCOA implementations, particularly for studies utilizing established clinical assessment instruments.

Licensing Requirements: Many clinical outcome assessments are copyrighted materials requiring study-specific licenses for electronic deployment. These licensing processes often involve multiple stakeholders and can require technical documentation, translation reviews, and approval workflows that extend implementation timelines.

Validation Processes: Electronic implementations of established instruments may require validation studies to demonstrate equivalence with paper-based versions. These studies ensure that electronic formats maintain the measurement properties and clinical validity of the original instruments.

Multi-Language Considerations: Global clinical trials require linguistic validation processes that extend beyond simple translation. These processes involve cultural adaptation, cognitive testing, and formal validation studies to ensure conceptual equivalence across different populations and languages.

Implementation Planning and Timeline Management

Successful eCOA implementation requires realistic planning that accounts for the various regulatory, technical, and operational requirements involved in electronic data collection deployment.

Timeline Variables: Implementation schedules depend on multiple factors including study complexity, regulatory requirements, licensing needs, translation requirements, and organizational readiness. Early identification of these variables helps establish realistic project timelines and resource allocation.

Change Management: Modifications to electronic systems after initial deployment often require coordination across multiple study components including visit schedules, data transfer processes, site training materials, and regulatory documentation. Planning for potential changes during the implementation process helps minimize disruption to ongoing studies.

Optimization Opportunities: Organizations with established eCOA capabilities may achieve implementation efficiencies through standardized processes, pre-validated instrument libraries, and streamlined approval workflows. These approaches can provide time savings when appropriate for specific study requirements.

Patient Engagement and Data Quality Benefits

The transformation from paper-based assessments to electronic systems addresses fundamental challenges in clinical data collection, particularly patient compliance and data accuracy.

Compliance and Completion Rates: Research has demonstrated that patients are significantly less compliant with paper diaries than previously assumed, with studies showing higher completion rates and more accurate data capture with electronic methods [Stone et al. 2002][4]. Electronic systems provide real-time data validation, immediate feedback to patients, and automated reminders that improve protocol adherence.

Patient-Centered Design: Modern eCOA platforms prioritize intuitive user interfaces and patient-facing technology improvements that accommodate diverse patient populations, including considerations for age, technical literacy, and accessibility requirements. This patient-centric approach recognizes that patients are experts in their own experience and should be empowered to provide accurate, meaningful data.

Real-Time Data Quality: Electronic capture enables immediate data validation, range checks, and consistency monitoring that identifies potential issues before they impact study integrity. This real-time capability supports both patient safety monitoring and regulatory submission requirements.

Implementation Best Practices and Workflow

Successful eCOA implementation requires systematic planning that addresses both technical and operational considerations throughout the study lifecycle.

Pre-Implementation Planning: Effective eCOA deployment begins with comprehensive assessment of patient populations, study requirements, and operational capabilities. This includes evaluating patient technology access, site infrastructure, and regulatory requirements across all study regions.

User Experience Validation: Testing eCOA interfaces with representative patient populations ensures usability across diverse demographics and technology comfort levels. This validation process should include cognitive interviews and usability testing to identify potential barriers to completion.

Training and Support Infrastructure: Comprehensive training programs for both sites and patients, supported by accessible technical support, are critical for successful adoption. This includes developing multilingual support materials and establishing clear escalation procedures for technical issues.

Data Integration and Monitoring: eCOA platforms must integrate seamlessly with electronic data capture systems and provide real-time monitoring capabilities that support both operational oversight and patient safety monitoring.

Technology Evolution and Future Considerations

Emerging Technologies: The eCOA field continues evolving with advances in mobile technology, wearable devices, and digital therapeutics integration. Organizations are increasingly exploring how these technologies can enhance patient engagement while maintaining regulatory compliance and data integrity.

Regulatory Adaptation: As regulatory agencies gain experience with electronic data collection approaches, guidance continues evolving to address new technologies and implementation approaches. Staying current with regulatory expectations remains essential for successful eCOA deployment.

Industry Standardization: Professional organizations and industry consortiums continue developing best practices and standardized approaches that can improve implementation efficiency and reduce regulatory review timelines across the industry.

 

Looking to implement eCOA solutions for your clinical trials? Discover how Castor’s integrated eCOA platform combines regulatory compliance with patient-centered design to accelerate your clinical research objectives.

Frequently Asked Questions

What is the difference between eCOA and ePRO?

eCOA (Electronic Clinical Outcome Assessment) serves as the umbrella term for all electronically captured clinical outcomes data. ePRO (Electronic Patient Reported Outcomes) represents the patient-reported component within the eCOA framework, alongside eClinRO (clinician-reported), eObsRO (observer-reported), and ePerfO (performance-based) outcomes.

How long does eCOA implementation typically take?

Implementation timelines vary significantly based on study complexity, regulatory requirements, licensing needs, translation requirements, and organizational capabilities. Early identification of these factors and realistic project planning help establish appropriate timelines for specific study contexts.

What are the key considerations for BYOD vs. provisioned devices?

The choice depends on study requirements, patient populations, regulatory considerations, and operational capabilities. BYOD approaches may improve patient engagement through familiar interfaces, while provisioned devices offer controlled environments. Both strategies require careful attention to data quality, security, and regulatory compliance.

How do licensing requirements affect eCOA implementation?

Many clinical assessment instruments are copyrighted materials requiring study-specific licenses for electronic deployment. These licensing processes can involve multiple stakeholders and approval workflows, making early planning and stakeholder engagement important for realistic timeline management.

 

References

  1. U.S. Food and Drug Administration. (2024). Clinical Outcome Assessment (COA) Frequently Asked Questions. Available at: https://www.fda.gov/about-fda/clinical-outcome-assessment-coa-frequently-asked-questions
  2. MarketsandMarkets. (2024). Electronic Clinical Outcome Assessment Solutions Market Growth, Drivers, and Opportunities. Available at: https://www.marketsandmarkets.com/Market-Reports/ecoa-solutions-market-87857774.html
  3. Clinical Leader. (2024). The Rise of Electronic Clinical Outcome Assessments (eCOAs) in the Age of Patient Centricity. Available at: https://www.clinicalleader.com/doc/the-rise-of-electronic-clinical-outcome-assessments-ecoas-in-the-age-of-patient-centricity-0001
  4. Stone, A.A., et al. (2002). Patient non-compliance with paper diaries. BMJ, 324(7347), 1193-1194. Available at: https://www.bmj.com/content/324/7347/1193

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Why eCOA Still Fails in Clinical Trials: Practical Strategies to Fix Baseline Data Problems

July 18th, 2025 by

Electronic COAs were meant to protect data quality and capture the patient voice. But missing baseline data, poor site preparation, and unrealistic timelines continue to break studies. In a frank discussion hosted by Castor, Derk Arts (Castor), Katja Rudell (Kielo Research), and Ari Gnanasakthy (RTI Health Solutions) unpacked where the breakdowns really happen — and how to address them practically.

“When you have 40% missing at baseline, you pretty much lost the study.” Ari Gnanasakthy

What Goes Wrong, Repeatedly in eCOA Clinical Trials

For over 20 years, eCOA has been positioned as a fix for data quality in clinical trials. But under pressure to launch quickly, the fundamentals still fail. Platforms aren’t validated in time. Sites are unprepared to train patients. Devices get stuck in customs. Sponsors overload studies with endpoints without checking whether sites can realistically execute them.

Ari gave a stark example: nearly half of baseline data lost because provisioned devices didn’t arrive on time. That kind of problem can destroy confidence in the entire trial, yet it keeps happening because sponsors focus on checklists rather than operational readiness.

“Defaulting to ePRO is fine. But when execution fails, confidence collapses.”

eCOA Organizational Friction and Clinical Operations

Many of these issues have little to do with the technology itself. They are organizational. Procurement departments pick eCOA vendors without involving scientific leadership. Clinical teams don’t leave enough time between protocol sign-off and first-patient-in. Multiple business units push conflicting priorities: commercial, HTA, regulatory, patient engagement — all pulling studies in different directions.

Katja noted even well-designed eCOA systems collapse when no one is coordinating translations, site training, device shipments, and ongoing data monitoring. When those hand-offs fail, secondary endpoints suffer, leaving massive data gaps no statistician can fix after the fact.

“Different teams chase different goals. That’s how data gets lost.” Katja Rudell

Practical Steps to Simplify eCOA Implementation

Derk challenged the group to question the myth of unavoidable complexity. In industries like aviation, change and surprises are planned for systematically. Clinical trials tolerate known failure points again and again — customs delays, missing devices, untrained staff — and act surprised every time.

The panelists pointed to several actionable ways forward:

Sponsors should also push vendors for true contingency planning. There is no excuse for having no Plan B in a study with critical endpoints.

“We act surprised every time these issues happen. That’s on us.” Derk Arts

A Path to Consistency and Patient-Reported Outcomes Success

No one suggested eCOA is fundamentally flawed. Quite the opposite: when done well, it supports high-quality patient-reported outcomes that add enormous value to a study. Ari reminded the audience that many trials do succeed — but those that fail, fail for predictable, preventable reasons.

Sponsors, CROs, and vendors should share lessons across studies, build repeatable playbooks, and train site staff continuously. Patients will only deliver quality data if their participation is practical and realistic — no matter what the protocol says on paper.

“If you expose patients to a product, you owe it to them to ask how they feel about it.” Katja Rudell

Key Takeaways

Watch the full webinar on-demand here for unfiltered, practical insights you can apply to your next clinical trial.

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Building Biotech: From Science to Scale – Strategic Lessons from the Frontline

May 28th, 2025 by

Biotech isn’t for the faint-hearted. As Derk Arts, CEO of Castor, and Professor Thomas Wurdinger discussed in their recent LinkedIn Live session, building a successful biotech company demands more than just groundbreaking science. Their conversation, titled “Building Biotech: From Science to Scale,” peeled back the layers on what truly drives success in early-stage biotechs. Spoiler: it’s less about having the best data and more about narrative, execution, and alignment.

Biotech, they argue, is the survival of the funded. It’s a terrain where the loudest story often drowns out the best science. Wurdinger’s own journey underscores this paradox. From his days as an RNA researcher to founding ThromboDx—a diagnostics company acquired by Illumina—and watching it evolve into Grail, his career exemplifies the rare but critical blend of academic depth and commercial savvy.

“Having the best data doesn’t guarantee funding, while poor data can often get you funded fast.”— Thomas Wurdinger

One of the most telling themes from the conversation is how market sentiment frequently trumps scientific merit. The Illumina-Grail case highlights this reality. Regulatory friction, misaligned expectations, and timing can vaporize billions in value overnight. In such a volatile landscape, a great idea needs more than validation; it needs strategy.

Wurdinger’s transition from the lab bench to the boardroom reveals the critical early decisions that separate promising biotechs from perishable ones. His threefold advice? First, founders must seek strong mentors who can help navigate intellectual property (IP), licensing, and fundraising. Second, never sign licensing or investment documents without independent legal counsel—no matter how friendly the university seems. And third, founders need brutal self-awareness: not everyone is meant to be a CEO, and clinging to titles can stall progress.

The tension between data quality and funding viability also took center stage. Many startups, especially those emerging from academic labs, struggle to convince VCs because their innovation doesn’t fit into the typical biotech investment playbook. Unlike therapeutic programs with clear regulatory and clinical pathways, platform or diagnostic companies must often invent their own roadmap—and articulate that roadmap convincingly to investors.

“Pride is your worst enemy when you’re in a startup.”— Thomas Wurdinger

This is where storytelling matters. Investors aren’t just betting on data. They’re betting on a vision, a team, and a well-crafted narrative that explains why now is the time, why this team is the right one, and why this solution matters. That’s why Wurdinger’s investment fund includes a filmmaker as one of the partners—to help founders construct that narrative arc. Because in biotech, your pitch deck is more than a slide show. It’s the first act of a story that investors must want to see through to its final scene.

While robust data underpins credibility, it’s often not the first thing investors see. Especially in early-stage funding, decisions are made based on the team, the problem-solution fit, and the ability to scale. Once a startup progresses, though, clinical readiness becomes critical. This includes preclinical validation, manufacturing scalability via CDMOs or CROs, and FDA registration planning. Without these, clinical trials are non-starters—and timelines slip fast.

Explore Castor’s tools for decentralized and hybrid trials

Wurdinger also offered pragmatic insight into fundraising phases. Many companies bridge the early-stage “valley of death” with government grants (like Eurostars) and local loans. Family, friends, and early believers play a crucial role, albeit a risky one. But to attract serious venture capital, companies need credible leadership, not just science. A seasoned CEO, clear go-to-market strategy, and defensible IP position are often the deciding factors.

Team-building was another recurrent theme. Founders should avoid perfectionism when assembling their leadership team. Instead, they need people who are aligned, resilient, and pragmatic. Equity dilution is not failure; it’s the price of momentum. The value lies in execution, not in retaining 100% of a stalled startup.

“You can’t get the best people in when you’re a startup and basically a nobody in startup land.”- Thomas Wurdinger

For first-time founders, Wurdinger left a final checklist: seek out mentors who challenge you; retain your own legal counsel; build your story before your data; and hire for your blind spots. Passion fuels the journey, but structure sustains it. No matter how disruptive your science, startups don’t scale themselves. They are built, step-by-step, through smart strategy, clinical readiness, and investor trust.

Platforms like Castor play a pivotal role here. As Wurdinger and Arts both noted, accelerating clinical operations through tech-enabled solutions is one of the few defensible edges in an increasingly competitive biotech ecosystem. With modern EDC systems, decentralized trial capabilities, and scalable workflows, Castor helps bridge the gap from hypothesis to human evidence.

The path from science to scale is long, but it’s navigable. With the right story, the right data, and the right team, even the most complex ideas can become transformative companies.

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From Hype to Health: What Sword Health Got Right About Evidence

June 26th, 2025 by

Most digital health companies struggle to prove they work. Sword Health didn’t. In this conversation, Fernando Correia (CMO, Sword) explains what they did differently—and why it mattered.

This article is based on a live webinar between Fernando and Castor CEO Derk Arts. You can watch the full conversation on-demand here: Watch the webinar.

Start with the Problem, Not the Pitch

MSK conditions affect 1 in 2 Americans. Sword saw that early and focused on building programs for large, well-defined problems—not niche use cases. They didn’t start with technology. They started with what clinical guidelines already said worked: exercise, education, and behavior change. Then they asked: how can we digitize and scale this without losing impact?

Proof Beats Hype

Back in 2015, digital care wasn’t taken seriously. Sword ran their first RCTs on paper to prove they could match in-person PT. It took three years to publish those first results. They knew they had to show outcomes before anyone would pay attention.

As they scaled, Sword invested in real-world data collection. They worked with product teams to embed validated outcomes into the user flow. They collected baseline and follow-up data at scale. Today, they have datasets with over 200,000 patients—including the largest real-world sample of low back pain patients in digital care.

Not Just a Tech Stack

Sword didn’t just build an app. They built a care delivery model—with humans, hardware, and AI. Their product includes motion capture, a CBT module, and Phoenix, an AI assistant. Clinicians manage 600+ patients with tech that flags risks and adapts plans. The goal: quality care at scale.

RCTs + RWE = Reimbursement

Sword’s trials showed they could match or outperform in-person PT—even when time and intensity were equal. Their real-world evidence showed sustained outcomes and lower healthcare utilization. That data got them contracts with payers and employers. Today, over 13 million people in the U.S. have access to Sword through their benefits.

Why Castor?

When Sword outgrew paper and spreadsheets, they needed a system their clinical team could own. Castor’s EDC let them build and run trials without code. During the pandemic, they ran two U.S.-based RCTs on Castor. The platform helped them publish faster, work more independently, and meet quality standards without bloated CRO costs.

Takeaways for Digital Health Teams

Sword didn’t just survive the hype cycle. They outlasted it. Evidence was the reason.

👉 Watch the full webinar on-demand

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How a 3-Person Team Got to Phase 3 — Without the Overhead

June 26th, 2025 by

A Hands-On Approach to Global Trial Execution

Gameto is a 20-person biotech. Their clinical operations team? Just three people. Yet that trio has designed and run nine studies across Peru, Mexico, Australia, and the United States—on their own infrastructure, without a big-box CRO, and without hiring dedicated data managers. They’re now in Phase 3 in the U.S. and already have commercial access in several countries.

What makes this story worth your time is how little was outsourced. Gameto didn’t hand off trial setup to consultants. They trained embryologists during live egg retrievals, used existing site relationships for implementation, and configured studies directly in Castor. Fast, focused, and regulator-ready.

“You’d be surprised what you can accomplish when there’s no other choice.”

— Sabrina Piechota, Clinical Ops, Gameto

Study Build in Weeks, Not Months

One randomized trial in Peru went from protocol to go-live in three weeks—in Spanish. It covered patient demographics, hormone labs, embryology results, pregnancy data, adverse events, image uploads, and randomization. The build came from Castor’s documentation and helpdesk—no special training, no delays.

“We don’t have six months to set up a database. We have three weeks.”

— Christian Kramme, CSO, Gameto

Data That Passes FDA Review

A 38-patient dataset—30 Fertilo, 10 control—moved the product straight into FDA Phase 3. Clean audit trails and rapid CRF versioning kept regulators comfortable.

“We’re constantly learning, so the platform had to let us adjust on the fly without losing quality.”

— Christian Kramme

Localization Without the Bottleneck

Modular CRFs with multilingual support let the team reuse core forms while adding local fields. Most issues were spotted through direct CRF review and fixed in real time—no extra headcount required.

A Global Head-to-Head Study, Run Lean

Next, Gameto will compare Fertilo to conventional IVF in Europe, Australia, the Middle East, and Southeast Asia. Same three-person core team, same platform, bigger impact.

“We’re not trying to build a giant apparatus. We want to stay nimble, stay close to our data, and scale smart.”

— Christian Kramme

Long-Term Follow-Up Built In

Maternal safety and two-year infant development metrics are already embedded in the registry. Patients complete milestone questionnaires every six months, feeding directly into the Castor database.

Watch the Full Conversation

This article distills key points from the fireside chat between Derk Arts (Castor CEO), Christian Kramme (Gameto CSO) and Sabrina Piechota (Gameto, Embryology Department Manager). For the complete discussion—including audience Q&A—watch the on-demand webinar here:

How Gameto’s Team Built a Phase 3 Trial Engine from the Ground Up (On-Demand)

What Larger Teams Can Learn

Speed is only half the story; precision is the other. By keeping data close to the scientists and trusting a flexible EDC, Gameto shows that lean execution can satisfy regulators and accelerate timelines. For sponsors tired of bloated vendor chains, this is proof that smaller, smarter teams can win.

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The Catch-22 of eConsent: The Missed Opportunity for Improved Clinical Trials

March 13th, 2025 by

eConsent technology is often praised for its potential to revolutionize clinical trials, yet it remains underutilized. The promise is clear: better comprehension leads to better satisfaction, retention, and protocol adherence. But the reality is much bleaker. Many implementations fail to deliver on this promise because they treat eConsent as a digital version of paper forms rather than as a transformational tool. This article explores the barriers holding eConsent back, backed by evidence from scientific literature, and proposes actionable solutions.

Why eConsent Matters: The Evidence

Multiple studies have demonstrated that interactive eConsent tools enhance patient comprehension compared to traditional methods. Taylor et al. (2021) showed that video-based consent interventions significantly improved participants’ understanding of trial concepts compared to standard consent forms. Their randomized trial across six clinical studies found:

“Participants exposed to the video had better understanding scores compared to those exposed to the standard consent form process.” (p = 0.020).

Moreover, Glaser et al. (2020) highlight that 85% of interactive, teach-back-based digital interventions successfully improved comprehension outcomes. They concluded:

“Interactive interventions, particularly with test/feedback or teach-back components, appear superior.”

Retention is another critical metric tied to eConsent. Skea et al. (2019) emphasize that participants drop out when they don’t feel adequately informed or when trial demands are misaligned with their expectations:

“Initial decisions to participate may not have been fully informed, leading to mismatched expectations and eventual attrition.”

These findings align with broader educational research demonstrating that interactivity and multimedia boost knowledge retention. For example, multimedia learning theory shows that combining visuals, text, and interactivity engages multiple cognitive pathways, enhancing understanding.

The Catch-22: Barriers to eConsent Adoption

Despite these proven benefits, eConsent remains stuck in a vicious cycle:

“The term ‘eConsent’ is often misunderstood, with many platforms offering only weak ‘design’ functions, which do not fulfill the full promise of digital tools.”

“Current practices often fail to define adequate patient comprehension and to ensure its assessment as part of the informed consent process, leading to frustration among sites.”

Breaking the Cycle: Unlocking eConsent’s Full Potential

  1. Example 1: Incorporating Interactive Features
     Taylor et al. (2021) demonstrated that video-based eConsent significantly improved satisfaction and understanding. If we give patients a short a video explaining key trial concepts, followed by an interactive quiz, we have already made real progress. This approach not only improves comprehension but also creates an audit trail for compliance.
  2. Example 2: Leveraging Educational Theory
     Studies on digital learning suggest that chunking information into bite-sized pieces and using visual aids enhances retention. A trial sponsor could use animated videos to explain randomization or potential side effects, coupled with glossary tools to define medical terms. Such tools could reduce dropout rates and enhance patient confidence.
  3. Example 3: Quantifying ROI
     Consider a large, global trial where dropout rates are reduced by just 5% through better eConsent. This could save millions in recruitment and operational costs. To encourage adoption, sponsors should calculate and share these savings, framing the initial investment as a long-term cost-saving measure.

Finally: just doing the right thing

Beyond the financial and operational arguments, eConsent represents an ethical obligation. As Pietrzykowski and Smilowska (2021) emphasize:

“The informed consent process actually leads to patients’ full comprehension of what they are consenting to. Unless this assumption is demonstrably true, the ethical viability of current medical experimentation practice is seriously flawed.”

This is also where I feel strongly. We are submitting patients to incomprehensibly long consent forms, knowing that comprehension will be low, but at least we’ve covered our legal bases.

Using multimedia and personalized tools isn’t just about better trials—it’s about respecting participants’ autonomy. When patients fully understand what they’re agreeing to, every stakeholder reaps the rewards.

To summarize, we must:

It’s time to move beyond treating eConsent as a checkbox and realize its full potential. The technology is ready—now the industry must commit to using it to create better, more ethical, and more successful clinical trials. Let’s break the cycle.

References

  1. Taylor et al. (2021). Randomized comparison of two interventions to enhance understanding during the informed consent process for research. Clinical Trials, 18(4), 466–476. doi:10.1177/17407745211009529
  2. Glaser et al. (2020). Interventions to improve patient comprehension in informed consent for medical and surgical procedures: An updated systematic review. Medical Decision Making, 40(2), 119–143. doi:10.1177/0272989X19896348
  3. Skea et al. (2019). Exploring non-retention in clinical trials: A meta-ethnographic synthesis of studies reporting participant reasons for drop out. BMJ Open, 9(6), e021959. doi:10.1136/bmjopen-2018-021959
  4. Vanaken et al. (2024). Effective eConsent strategies for every study: Utilizing the eConsent fit-for-purpose study framework. Applied Clinical Trials. Available online.
  5. Pietrzykowski & Smilowska (2021). The reality of informed consent: Empirical studies on patient comprehension—Systematic review. Trials, 22(1), 57. doi:10.1186/s13063-020-04969-w

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Measuring the true patient experience in Cancer Trials with eCOA / ePRO

March 22nd, 2024 by

Our recent webinar featuring PRO expert Ari Gnanasakthy, RTI Health Solutions, and Derk Arts, CEO & Founder, Castor, sheds light on the complexities and advancements in measuring PROs, drug tolerability, and quality of life in cancer trials. Here, we distill the insights shared and explore the implications for future research.

Cancer studies are not what they used to be

Derk and Ari kicked off their conversation by discussing how cancer research is getting more and more complex and with this ever-evolving landscape, a focus on patient-reported outcomes (PROs) and clinical outcome assessments (COAs) has never been more critical. With the emergence of innovative treatments such as plasma-derived therapies, CAR-T therapies, reductions in chemotherapy cycles, and a surge in novel oral medications, the shift towards more personalized and targeted therapies underscores the necessity to move beyond traditional PRO methodologies.

In this new era, a more patient-centric approach is needed, ensuring that treatment strategies not only combat the disease effectively but also offer real-time insights into treatment efficacy, patient well-being, tolerability, and quality of life (QoL).

“Let’s stop talking about patient reported outcomes, instead let’s talk about the patient experience and the ways we measure QoL within all the nuances of cancer trials.“

– Ari Gnanasakthy, RTI Health Solutions

Navigating the regulatory landscape

The webinar delved into the changing regulatory landscape for cancer trials, particularly for measuring PROs. As treatments like CAR-T cell therapy become more prevalent, capturing the authentic patient journey has become more crucial for understanding both efficacy and safety. Regulatory bodies are increasingly emphasizing the importance of real-world evidence, pushing for a more comprehensive view of treatment impacts. This shift necessitates meticulous planning in data collection, not only to meet regulatory approval requirements but also to address the downstream needs of payers. Having this dual focus ensures that the collected information serves both immediate regulatory purposes and future payer evaluations, facilitating a smoother transition from clinical approval to market access. With the rise of personalized and targeted therapies, the reliance on outdated PRO methodologies is no longer viable. Clinical trial design needs to reflect a balance between scientific rigor and patient-centricity, ensuring research outcomes are both scientifically valid and meaningful to patients’ lives.

Who says the drug is tolerable?

The Patient. A critical aspect of the discussion between Ari and Derk centered on the concept of measuring treatment tolerability and QoL within cancer research. The conversation highlighted a need to shift perspectives, with emphasis on understanding how tolerability influences patient adherence and overall treatment outcomes. Ari emphasized the importance of viewing tolerability through a comprehensive lens and throughout treatment cycles.

“Tolerability is not something that can be measured at the beginning of each cycle when patients are reasonably healthy. Tolerability is something that needs to be measured when patients are having issues and when the drug is at peak, during cycles…probably on a weekly basis.”

– Ari Gnanasakthy, RTI Health Solutions

But how do we consistently measure something so subjective in a scientific way? Tolerability is not just one measure but a number of elements that need to be considered, including safety data, treatment data and PROs (like physical and role function, side effect burden or even hair loss). It is clear we need to consider both the physical and psychological nuances of patient experiences when assessing treatment tolerability.

Elements of treatment tolerabilityWhat does the future hold for ePRO?

Finally, Derk and Ari spent time looking ahead at how the role of technology and ePRO in cancer research is expected to expand. Wearables, BYOD (Bring Your Own Device) strategies and advanced scheduling for data collection will play pivotal roles, enabling real world data collection that reflects the true impact of cancer treatment on patients’ lives.

This digital-first approach is anticipated to improve data quality and drive more patient engagement. By engaging patients through their own smartphones and leveraging technology they are familiar with, clinical trials can more accurately measure the true patient experience, thereby improving participation and adherence. Additionally, ePRO technology offers solutions to challenges around data integrity and overcoming the “parking lot effect,” where responses may be influenced by the immediate environment of data collection. This evolution marks a pivotal step towards more patient-centric research and ultimately better outcomes.

“It’s now clear that we’re dealing with three layers of data. Initially, we have the core data that has been the focus for the past two decades. Added to this are scheduled QoL and tolerability data. The final layer encompasses wearable and ad hoc data, enriching our understanding of tolerability. This stratified approach presents a significant opportunity to enhance patient outcomes.”

– Derk Arts, Castor Founder & CEO

And, from the sponsor side, it’s imperative to consider the influence of Quality of Life (QoL) and tolerability measures on the drug’s value proposition. For sponsors, overlooking this aspect could lead to a significant gap in their value proposition.

The single line item from the FACT-G questionnaire, GP5, which asks patients if they are “bothered by side effects of treatment,” has demonstrated a strong predictive value for both patient dropout and disease progression when patients report being troubled by side effects. This underscores the importance of integrating patient-centric measures into clinical trial design and evaluation to enhance patient retention and treatment outcomes.

Getting started with Castor eCOA / ePRO

To deepen the understanding of eCOA / ePRO technology for sites and sponsors, and to ensure fast study builds, Castor welcomes study teams to explore our eCOA / ePRO platform by offering early access, and allowing them to personally navigate the patient experience. Our comprehensive onboarding process and dedicated customer support play a pivotal role in this commitment. Additionally, we provide the option to work with synthetic data upfront, offering a proactive approach to risk mitigation.

At the heart of our platform is a patient-centric approach, designed to significantly improve the trial experience for participants. By prioritizing the patient perspective, we aim to enhance engagement and collect valuable real-world data. This data is crucial for gaining insights into treatment effectiveness, patient well-being, tolerability, and quality of life, in the ever changing landscape of cancer research.

For more information, watch our on-demand webinar:
eCOA / ePRO and Cancer Research – Measuring the true patient experience

Follow us on LinkedIn: Castor

Learn more about Castor eCOA / ePRO

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The Place of COAs / PROs in the Future of Healthcare

March 9th, 2024 by

Over recent decades, we’ve witnessed a pivotal shift in the global healthcare landscape. As chronic conditions have become more prevalent, nations worldwide have been reevaluating their healthcare delivery models, moving away from traditional fee-for-service models towards a more outcomes-focused approach. Both governments and private payers are now pondering a critical question: “How can we reimburse healthcare providers based on the positive outcomes for patients, rather than just for the services they provide?”

Value-Based Care

Value-Based Care (VBC) programs represent a transformative approach in the healthcare industry, aimed at improving patient outcomes, enhancing care quality, and reducing healthcare costs. Unlike traditional fee-for-service models, which reimburse healthcare providers based on the quantity of care services delivered, VBC focuses on rewarding providers for the quality and effectiveness of care they provide to their patients. This model aligns financial incentives with patient outcomes, encouraging healthcare providers to offer care that is both efficient and tailored to the individual needs of patients.

The impact of VBC on the healthcare ecosystem is multifaceted. Firstly, it prompts a shift in the focus of healthcare delivery from treatment to prevention and patient wellness. By incentivizing positive patient outcomes, VBC encourages providers to invest more in preventive care measures, chronic disease management, and holistic approaches to patient health. This can lead to a decrease in hospital readmissions, fewer unnecessary medical procedures, and overall, a more sustainable healthcare system.

Secondly, VBC fosters collaboration among healthcare providers. Since the model rewards the improvement of patient outcomes across the continuum of care, it encourages different providers to work together more closely. Hospitals, primary care physicians, specialists, and even non-medical support services are motivated to share information and coordinate care more effectively, ensuring that patients receive the right care at the right time.

Patient-Reported Outcomes (PROs) play a crucial role in the success of VBC programs. PROs are direct reports from patients about how they feel in relation to a health condition and its therapy, without interpretation of the patient’s response by a clinician or anyone else.

This information is invaluable because it provides insights into the patient’s perspective on their health status, quality of life, and the effectiveness of treatments.

In the context of VBC, PROs help to ensure that care delivery is genuinely patient-centered, enabling healthcare providers to tailor their interventions to meet the specific needs and preferences of each patient.

PROs contribute to the measurement and assessment of healthcare outcomes, which is central to VBC. By incorporating PROs into their assessment criteria, VBC programs can use this data to evaluate the effectiveness of care from the patient’s viewpoint. This ensures that healthcare interventions not only achieve clinical objectives but also improve the quality of life for patients. Consequently, PROs are essential for the continuous improvement of healthcare services, guiding providers towards interventions that offer the greatest benefit to patients’ health and well-being.

PROs in Clinical Trials

When life sciences companies present data from clinical trials that include PROs, they provide a more comprehensive picture of a product’s benefits. This evidence is particularly persuasive to payers and healthcare providers, who are increasingly looking for treatments that offer meaningful improvements in patients’ lives, not just clinical metrics. For payers, such information supports decision-making related to coverage and reimbursement, as it aligns with the shift towards outcomes-based reimbursement models. Products that demonstrate a positive impact on patients’ quality of life are more likely to be covered and recommended within these frameworks, ensuring broader access for patients.

Similarly, healthcare providers, who are integral to the VBC ecosystem, are more likely to prescribe products that have been shown to enhance patient outcomes and satisfaction. In the context of outcomes-based care, providers are rewarded for delivering high-quality, patient-centered care, which includes prescribing treatments that patients are more likely to adhere to because of their favorable impact on quality of life. Therefore, clinical trial data enriched with PROs can significantly influence prescribing behaviors by highlighting the patient-perceived benefits of a treatment.

The inclusion of PROs in clinical trials signals to both payers and providers that a life sciences company is committed to understanding and addressing the holistic needs of patients. This can strengthen the company’s position in negotiations with payers and foster trust among healthcare providers, facilitating the successful adoption of new products.

PROs bridge the gap between clinical efficacy and patient experience, enabling life sciences companies to better meet the demands of the evolving healthcare landscape where the patient’s voice is increasingly central to care decisions.

Leveraging PROs in clinical trials is not just about enhancing the evidence base for new medical products; it’s about aligning these products with the fundamental principles of VBC and ensuring they meet the real-world needs of patients, payers, and providers. In doing so, life sciences companies can enhance the marketability of their products, ensuring they are well-positioned for successful adoption, coverage, and use in a healthcare environment that values and rewards meaningful improvements in patient health and quality of life.

For more information, follow us on LinkedIn: Castor | Kristen Harnack

Learn more about Castor’s eCOA / ePRO

References:

  1. CMS (Centers for Medicare & Medicaid Services). “Value-Based Programs.” [CMS website]
  2. Health Affairs. “Value-Based Care and Population Health: Opportunities and Challenges.”
  3. HHS (Department of Health & Human Services). “About the Affordable Care Act.” [HHS website]
  4. FDA (Food and Drug Administration). “Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims.” [FDA website]
  5. Journal of Managed Care & Specialty Pharmacy. “Patient-Reported Outcomes in Performance Measurement.”

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6 Steps for Using eCOA / ePRO & Physician Surveys to Fulfill MDR PMCF

March 5th, 2020 by

To ensure ongoing regulatory compliance under the EU MDR, medical device manufacturers must demonstrate the safety and performance of marketed devices with data obtained through Post-Market Clinical Follow-up (PMCF) studies, which often include patient and physician surveys.

ePRO & Physician Surveys consulting graphic

When your PMCF plans include surveying physicians and other healthcare professionals or administering questionnaires to patients, physician survey forms or electronic Clinical Outcome Measures (eCOA) must be created to prepare for PMCF execution. The Regulatory Affairs Professionals Society (RAPS) described PMCF planning under EU MDR as a burden to manufacturers in an article dated 12 September 2019. To ease this burden, Castor’s technology can help automate PMCF execution so that the entire process can run smoothly and efficiently.

Physician Surveys

Depending on the type of device under PMCF scrutiny, electronic Physician Surveys may be the most effective route to submit relevant PMCF data on medical devices. This might be the case with devices used during certain surgical or endovascular procedures, or with devices that are implanted and require follow-up assessments with a healthcare provider (HCP). In such cases, HCPs may be invited to answer surveys focused on device clinical performance and safety outcomes in either a prospective or retrospective fashion using Castor-generated eCOA called a Clinician Reported Outcome (ClinRO) or Performance Outcome (PerfO) forms.

ePROs

Certain devices may benefit from a different approach in PMCF data collection. For example, devices intended for patient use such as insulin pumps or wearable devices may be better suited for ePRO or Observer Reported Outcome (ObsRO) forms, where patients themselves or their guardians submit PMCF data either prospectively or retrospectively. In such cases, patients/guardians can be recruited through marketing campaigns or via their providers to answer PMCF-tailored questionnaires in the form of ePROs/ObsROs.  

Just five steps can help you become compliant with PMCF requirements. Download our whitepaper to learn how.

How do you create Physician Surveys and ePROs?

With Castor, you can easily set up Physician Surveys or ePROs and send them to survey participants via email in a few, simple steps.

1. First, you will determine the structure of the survey by choosing the survey type as either a Physician Survey or an ePRO and by indicating the device type. For instance, you could identify your survey as an “Angioplasty device” as illustrated below:

PMCF_Structure

2. Second, you will type in the survey questions as in the example below: 

PMCF_Forms

Alternatively, you may be able to import existing survey samples from the Castor Form Exchange by downloading the survey structure and importing it into your PMCF study in Castor.

3. Once the survey structure and questions have been set up, a survey package should be created. You will be prompted to enter the sender’s name, the email subject, email text, and other survey properties as illustrated below:PMCF_survey_package

4. The survey package is now ready to be sent to participants. You can send your PMCF survey to a group of participants in bulk after importing their email addresses. Alternatively, you may send your PMCF survey to single participants. Surveys can be sent on a certain date or according to a specific follow-up schedule of your choice, for instance once every month for four months as illustrated below:

PMCF_survey_invitation

5. The respondent will receive an email with a unique link, which will redirect to the PMCF survey.  PMCF data collection will begin immediately as participants start responding, and their answers will be saved in real time in your Castor PMCF study. During PMCF data collection, you will be able to track the progress of your study at any time, as illustrated below.

Study Health Dashboard showing inclusions over time:PMCF_Study_Health_Dashboard

Study Health Dashboard showing record progress:PMCF_record_progress6. When the expected volume of PMCF data has been collected, you can export and analyze the data in your preferred format, for example SPSS, Excel, CSV, Restful API, HTML, or as a PDF.

Here is an example of an Excel export:

PMCF_excel_export

Here is an example of a PDF export for a single survey:PMCF_PDF

Here is an overview of survey response frequency:

In conclusion, when your PMCF plans require sending surveys to physicians or questionnaires to participants, physician survey forms or electronic Patient Reported Outcome (ePRO) forms must be created to prepare for PMCF execution. Castor helps you efficiently execute your PMCF plan through ePRO and electronic Physician Surveys. Contact our team to discuss how Castor’s technology can help you fulfill MDR and PMCF data requirements.

PMCF 5 Steps

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