If you run clinical studies at a medical device, diagnostic, or IVD company, you know the trade-off. Enterprise EDC systems carry cost, complexity, and build time that a low-complexity study never needs. Spreadsheets are cheaper, but they hand an auditor nothing usable. Teams running early or low-complexity studies get stuck between the two.
In a recent 30-minute product spotlight, Lisa Charlton, Chief Product Officer at Castor, and Angie Martinez, Senior Solutions Consultant, showed a third path and built a compliant study live, with no code, on the Castor Essentials program. The value was not the feature tour. It was seeing how a device team gets from protocol to audit-ready data capture in weeks, and where that entry point leads as a program grows toward post-market evidence.
The dilemma, and the middle path
Lisa opened on what she called the med tech data dilemma. Systems built for large pharma programs bring complexity and long build times that a simpler device study does not need, which makes them a poor fit for the work. Castor Essentials is built for that gap: a unified electronic data capture system and ePRO platform with a native randomization module, self-service, and 21 CFR Part 11 compliant from the start. Lisa noted that low-complexity self-service studies average three to four weeks to build.
Angie then built a study live and framed the approach up front:
Everything you’ll see here today is designed to be self-service, low to no code, and 21 CFR Part 11 compliant right out of the box.
In the build, Angie showed data entry saving in real time, edit checks that flag a coordinator before they leave a field, and an immutable audit trail behind every action. Randomization was the standout. Rather than a separate contract, it runs inside the EDC:
Historically, if you wanted randomization, you might have to contract with an expensive third-party system and spend weeks building custom APIs. We have a native randomization module inside our EDC.
From there she moved through monitoring and risk-based source data verification, an ePRO survey completed on a phone, and on-demand data exports, all from the same platform.
What Castor Essentials includes
- Unified EDC, web-based ePRO, and a native randomization module
- No-code build, with Castor Academy training and support
- Three to four weeks to build for low-complexity studies
- GDPR compliant, ISO/IEC 27001 certified, and 21 CFR Part 11 compliant
- Data hosting across the US, EU, UK, and Australia for data residency
- Over 800 medical device studies supported to date
What the recording covers
The full session goes deeper than a summary can. Angie walks through the native randomization setup, including stratification by site and severity and variable block sizes, and how blinding is handled (11:32). She puts on a monitor’s hat to show the centralized query command center and how risk-based verification is configured with a single click (12:50). Later she demonstrates Form Sync, which creates a linked, non-live copy of a study so a team can test changes and merge them into production with no downtime (35:05). And the Q&A gets specific: moving an active trial from another EDC mid-study (28:40), and how eConsent, part of the fuller Castor platform, can create the EDC record while keeping patient identifiers separate and encrypted (43:35).
From entry point to evidence program
The session did not stop at the build. Lisa pointed to where an Essentials study goes next. As a device program moves toward post-market obligations, Castor’s data management team can take on the build and query management, and Castor Catalyst adds AI-assisted extraction of source records, with human review, for PMCF and direct-to-patient evidence. Essentials is the fast, compliant way in, and the same platform carries the program through to the evidence a post-market plan demands.
Watch the build, then map your path
Watch the full 30-minute live build on demand, then see where an Essentials study can go as your evidence needs grow.
Questions from the session
Can I migrate an active trial from another EDC to Castor?
Yes. The team explained that migrating an in-flight study mainly depends on the file type your current EDC exports (for example CDISC ODM, CSV, or Excel) and how many data points are involved, which drives the effort. Castor can convert and import that data in parallel while you build the study and prepare to go live.
If I upload a CSV, does the data map to existing fields or create new ones?
The form has to be built in Castor first. Not every column needs to match, as long as the system can match the participant ID and your variables are labeled correctly, it maps the columns automatically regardless of their order. If a participant record does not yet exist, the import creates it with the fields captured in the file.
How much of the build can the API do?
Castor is API-first, with publicly available APIs. You can build, push data, and pull data through them, and integrate with wearables, digital health devices, EHRs, and RTSM or IRT systems. Study structures can also be imported in XML and CDISC ODM formats.
Can Castor integrate with our CTMS?
Yes. The team confirmed CTMS integration is done regularly, using Castor’s APIs. The platform is built to be interoperable, whether you are exporting data or connecting to other systems.
Can I outsource EDC and data management together?
Yes. Castor has an in-house data management team that supports study build, query management, eCRF generation, data validation plans, and post-go-live activities, so you can outsource EDC and data management as one engagement.
What if we must host data only on EU-based servers?
That is supported. You choose the server region where your study is built and your data is stored. Castor offers data hosting across the US, EU, UK, and Australia to meet data residency requirements.