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.