Bring Your Medical Device to Market: Fast, Reliable and Low Risk
Castor is your full-service partner for medical device and diagnostic studies. Our modular platform and expert services accelerate your feasibility, pivotal or PMCF study while ensuring full regulatory compliance.
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Your Journey to Regulatory Success
End-to-end support across every study phase.
- Design and Launch: Launch studies in as little as 6-8 weeks through expert-led builds, dedicated site onboarding and ongoing support.
- Engage Sites and Patients: Minimize burden through video-enabled eConsent, and mobile-friendly ePRO.
- Capture High-Quality Data: Real-time capture via EDC, ePRO, wearables, and integrated APIs, with built-in edit checks and compliant exports.
- Analyze and Submit: Export submission-ready files in CDISC, Excel, SAS. Reuse structures and automate amendments with Form Sync.
Reliable technology and expert services for medical device studies
Pilot and feasibility
Build your technology foundation early with Castor’s EDC and grow with our virtual tools as your research evolves.
- Get started with Castor EDC to digitize and streamline early-stage data collection.
- Add eConsent or ePRO modules to enroll and engage with patients remotely.
- Access world-class support for site onboarding and central study teams.
Pivotal
Capture clean data and deliver submissions with confidence using one unified platform.
- Meet compliance needs for MDR, IVDR, CE Mark, and FDA De Novo.
- Confidently outsource your study build to Castor’s expert Professional Services team.
- Trusted with 800+ MedTech Studies Worldwide.
Post-marketing surveillance and PMCF
Drive RWE with continuous, real-time data collection that meets regulatory and market demands.
- Efficiently capture and manage PMCF data through Castor’s eCRF and ePRO modules.
- Benefit from pricing models tailored for running multiple PMCF studies at scale.
- Confidently onboard your internal teams with Castor’s training and support.
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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See Castor and our partners in action
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