Build and test draft studies, then follow live study progress through natural-language requests.
Sequencing eConsent, EDC and ePRO on one patient record, and what a module-by-module rollout costs you.
What separates a clinical trial EDC from a registry platform: multi-year follow-up, multi-source collection, PMCF and PSUR reporting.
Thirteen EDC platforms grouped by the studies they fit, each with what it does well and where it stops.
Three EDC vendors all say they support MCP. One searches the manual, one reads your numbers, one builds your eCRF. Four levels for telling them apart.
Patient database, digital recruitment, visit scheduling, participant communications and payments. Live product session on October 1, 2026.
V5 is a full rewrite of the Datacapt EDC Builder. Form templates, AI-assisted design, readable edit checks, live preview and your own AI over MCP.
An AI agent connects to an EDC through MCP, builds an eCRF and reads monitoring metrics. No clinical data reaches the model.
What EMA and FDA 21 CFR Part 11 ask of a validated system, the ALCOA+ principles behind it, and the steps that keep that state through releases.
MDR asks manufacturers to keep collecting clinical data after CE marking. How a PMCF plan is built, and how it links to PMS, CER and PSUR.
One tracks the study, the other captures the data. Where the two overlap, and how they work together on a trial.
What keeps participants in a study: retention drivers, ePRO and eConsent tools, and the effect on the data you collect.