Navigate Medical Device and Diagnostic Research with Ease
No matter your level of expertise, Castor’s eClinical suite allows medical device and diagnostic researchers to build a technology foundation that meets varying study and regulatory needs.
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Powerful solutions for medical device clinical trials
Go live with your study in as little as 4 weeks.
- Collect and exchange data with minimal training
- Navigate varying regulatory needs with a single compliant platform
- Make amendments to research protocols with ease
Flexible tech for the trials of today – and tomorrow
Pilot studies and beyond
Build a foundation of technology that meets your pre-clinical needs, and keep adding virtual elements as your research grows.
- Get started with Castor’s EDC as a launchpad for digitization success.
- Add eConsent or ePRO modules to enroll and engage with patients remotely.
- Access world-class support for your central study teams, as well as sites conducting data entry.
Pivotal and feasibility
Efficiently capture and manage data on one platform to accelerate delivery of FIH, Pivotal, and Feasibility studies.
- Support compliance with MDR, IVDR, CE mark, and FDA De Novo submissions.
- Set up studies on your own with no training required. If you need help, find out how to build a study for free with Castor Academy, or let our Professional Services team build it for you.
- Combine data with eCRF, eCOA, ePRO, wearables, and EHRs using Castor’s open API.
Post-marketing surveillance and PMCF
Continuously capture data to meet regulatory, marketing, and product development needs for post-market clinical follow-up (PMCF).
- Reuse eCRFs, surveys, and data integration services and deploy your study in 4 weeks.
- Enable participants to complete study assessments from their own devices with Castor Connect.
- Connect your devices through Castor’s API and support continuous real-world-evidence (RWE) generation.
- Monitor queries and validations in real-time with Castor’s comprehensive reporting dashboards.
Take your clinical data further, faster
Data capture (Castor CDMS / EDC) Accessible and self-service platform that empowers both novice and experienced users to design and build eCRFs, collect and manage data, and always feel in control of your study workflow.
Data capture (Castor CDMS / EDC) - Support and services
Castor offers 3-level SLA for ongoing support, as well as optional services to outsource study builds and other key activities when needed through TAM, training and IRB submission support services.
Support and services - ePRO, eCOA, and patient diaries
Increase patient engagement with an enhanced patient experience & relieve admin burden by improving data collection with Castor’s ePRO module and a dedicated ePRO mobile app.
- Sensors and API interoperability
Collect real-time biometric and other digital endpoints with Castor’s API-first approach.
ePRO, eCOA, and patient diaries 
Sensors and API interoperability - Hybrid eConsent for remote or onsite consent
Minimize patient visits while improving patient engagement and understanding with Castor’s eConsent solution.
- Security and compliance
Castor’s technology and services meet global regulatory and compliance certifications: FDA CFR Part 11, GDPR (EU), ICH GCP (HIPAA, US), ISO 27001, and ISO 9001.
Hybrid eConsent for remote or onsite consent 
Security and compliance 
Whitepaper
Will your device meet safety and performance requirements?
Learn the key tenets of MDR by device classification, and what items must be addressed to be fully compliant.
Generate compliant data, confidently
Castor’s technology and services meet global regulatory and compliance certifications on private and secure infrastructure. Our compliance ensures you have access to the validation documentation needed for each phase of your internal regulatory compliance process.
- Store data securely
- Save study data in real-time.
- Store it automatically on certified, compliant servers in any country.
- Protect your data with 15-year data retention, field-level encryption, and two-factor authentication.
Store data securely - Amend studies with less risk
- Simplify protocol amendments by using a tool that’s secure, trackable, and easy-to-validate.
- Easily create test environments for each of your subsequent studies.
Amend studies with less risk - Achieve global compliance
- Meet compliance certifications worldwide such as FDA CFR Part 11, GDPR (EU), ICH GCP (HIPAA, US), ISO 27001, and ISO 9001.
- Align with GCP, HL7 FIHR, and other regulatory guidelines.
Achieve global compliance - Gain real-time insights
- Get an overview of study statistics as your studies are ongoing.
- Track record data entry progress and outstanding queries.
- View Source Data Verification (SDV) status
Gain real-time insights 
Ready to get started?
Castor’s eClinical suite is uniquely designed to help medical device and diagnostic companies reduce administrative burden, accelerate timelines and guarantee compliance.
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