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Manage data for your entire medical device and diagnostics development lifecycle
Post-Market Surveillance (PMS)
Continuously capture data from devices, patients (ePRO), and EMR systems to meet regulatory, marketing and product development needs, including PMS, PMCF, and RWE.
Castor for PMCF →
Preclinical Studies
Capture high-quality data from the start on a secure and compliant platform. Seamlessly transfer your study designs to the next development stages.
Clinical Studies
Efficiently capture and manage all data in one place to simplify and accelerate delivery of FIH, Pivotal and Post-Marketing studies, supporting compliance with MDR, IVDR, CE mark, and FDA De Novo submissions. Easily build studies on your own or let us do it for you.
Tailored for device and diagnostics trials
- Easily set up studies on your own — no training required
- If you need help, we can conduct study design, build, and data management for you
- Real-time validation and edit checks
- Easily edit forms mid-study to accommodate protocol amendments
- Capture patient data (ePRO & eCOA) and clinician data (eCRF) on a centralized platform
- Integrate your devices and wearables using our API
- Our cloud-based platform enables secure access worldwide
- Remote-monitoring and granular user access rights
- Randomize patients with our validated IWRS module
- Competitive pricing
- Bundle discounts for multiple studies
- Get visibility into study health with dynamic dashboards
- Track studies from start to finish
- Export in CSV, Excel, SPSS or R
- Analyze in the tool of your choice (SAS, STATA, SPSS or R)
- Get expert help in less than 30 minutes during business hours
- Ongoing support to the central study team as well as to the sites conducting data entry
Efficiently manage your internal regulatory compliance process
Our compliance package ensures you have access to the validation documentation needed for each stage of your internal regulatory compliance process.
Industry-leading security
Data security is paramount to protect your data. We are ISO27001 certified, and features like field encryption and user-management put you in control of data access.
Compliant with international laws and standards
Castor helps you comply with MDR and IVDR, and is FDA 21 CFR Part 11, EU GMP Annex 11, ICH E6 Good Clinical Practice, HIPAA, and GDPR compliant.
Reduce cost and information overload
With a qualified team of experts, Castor can support you with study design, setup, conduct, and regulatory processes.
Maximize value from data
Castor’s technology helps you maximize value from both internal and Investigator Initiated Study data to efficiently get your devices to market.
Our customers love us
"EDC system for our medical device study"
“Castor enabled us to securely capture and integrate data from many sources. We needed a user-friendly EDC to automatically capture data from our device and patients and accelerate our research. Castor’s solutions and support helped us to quickly complete our device study and get it on the market.”
-Peter Gaarde, RSP Systems
"EDC system with multifunctional capabilities"
“It’s been great working with Castor, and their customer service always responds so promptly and is always super helpful. Easy data download process and great interface.”
-Arick Wong, Lucira Health
"Reliable EDC system"
It’s really easy setting up the data collection process for your study. The customization is great. Castor also does not charge you until your study goes live, which takes a lot of pressure off of the set up time, which is ultimately the longest and most difficult part when getting started with an EDC system.
-Alexandra Krajcevska, Theranova
"Best value and also best product
“This product includes EVERYTHING you can find in all of the competing products, including the regulatory requirements, but is so much less expensive that it is not even worth checking out the other companies. This is my go to platform for all of my clients’ clinical trials.”
-Sharon Goldfarb, SGConsulting
"Intuitive platform, easy to set up"
“We found Castor EDC very easy to set up on our own and use. We always get an answer straight away when we have questions. It’s a cost-effective alternative to paper CRFs and much safer and easier to use.”
-Petra Jongmans, Atos Medical
"Excellent features"
“Impressive flexibility, ability to customize forms with (almost) any imaginable feature/data flow. Castor EDC is a great product with prompt and knowledgeable customer support.”
-Elena Allen, Rodin Scientific