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.
Use cases, practices and preparation steps for moving clinical data between systems without a manual export.
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Building patient questionnaires, automating reminders and reading the compliance dashboard. Replay of the product session.
The FDA framework, eIDAS levels, and what an ethics committee expects to see behind a patient signature.
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Recruitment reach, site burden and monitoring cost pull in different directions. Criteria for picking a model for your protocol.