Today we open early access to Datacapt V5, a complete rewrite of the EDC Builder. Same platform, same audit trail, a new way to build a study. Here is what changes for your next protocol.
A structure that reads like your protocol
Visits and forms sit in a tree: screening, treatment cycles, unscheduled visits, plus common forms available at every visit. You build the study the way the protocol describes it.
Build a form once, reference it everywhere
Save a form as a template and reference it in each visit of the study structure. Edit the template and every visit follows. The item library works the same way: standards-coded items with code lists, units and edit checks attached, defined once and reused across studies.
Describe it, V5 drafts it
Type the protocol in natural language or attach the PDF. Datacapt AI drafts the eCRF, the visits and the edit checks. Give it a data validation plan and it writes every check with the query text your sites will read. Ask for a CDASH review and it flags each variable that does not comply. You validate every field before anything moves further.
Edit checks you can read out loud
Compose a check from blocks. Cross-form and cross-visit conditions use the same blocks, with no script to maintain. Formulas get a real expression language: IF, THEN and ELSE, functions, variables from any form or visit, validated as you type.
See the form the way the site will
Drag questions into place, set their properties in the side panel and switch to preview at any moment. Desktop and phone, filled with sample data, with every edit visible as you make it.
Plug in your own AI
V5 ships an MCP server, in beta. Connect Claude, ChatGPT or your in-house model with one key per user. It reads study metadata and aggregates, writes drafts only, and every call lands in the audit trail with its MCP origin. Read how we built it.
What else changed
- Five export formats: CSV, XLSX, SAS, JSON and PDF.
- Import forms, items and code lists from CSV and XLSX.
- Multi-language forms, translated in place.
- Granular roles for who designs, reviews and publishes.
- A faster engine: large studies open, edit and publish in a fraction of the time.
Study versioning with a change log arrives after the launch. Every builder action is already recorded in the audit trail, on EU hosting under ISO 27001 and HDS.
See it on your own study
Early access opens now. Explore Datacapt V5, then book a 30-minute demo and we walk you through the builder on a study like yours.
