Decentralised Clinical Trials distribute study participation across remote patients, community pharmacies, and virtual investigator sites — dramatically expanding the network of endpoints, data entry devices, and clinical data flows that must be secured to GCP and 21 CFR Part 11 standards without the physical controls available in traditional trial sites. Zero Trust provides the identity-verified, device-validated access model that allows trial sponsors and CROs to enforce protocol-specific data access for remote investigators, patients, and monitors while maintaining the audit integrity required by FDA and EMA.
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