Regulatory frameworks are shifting, patient expectations are rising, and the evidence base for data return is growing. We look at where the field is heading and what sponsors need to do now.
The revised Good Clinical Practice guideline signals a meaningful shift toward participant-centred research. EBB breaks down what ICH E6(R3) means in practice for data return obligations.
EBB is built on a stateless streaming model: participant data passes through to generate a report and is never retained. We explain why this matters for GDPR compliance and sponsor risk.