Beyond Compliance: How Sponsors Can Drive Success With Central eSource At Investigator Sites

As global clinical trials grow more complex, sponsors and CROs are increasingly seeking innovative tools that enhance quality, compliance, and efficiency. Centralized electronic source (eSource) systems—designed to provide investigator sites with protocol-aligned, preconfigured source documentation—are emerging as a powerful solution. This article explores how the central eSource model aligns with key regulatory frameworks, including ICH E6(R3), ICH E8(R1), and 21 CFR 312, to meet the highest standards of Good Clinical Practice (GCP).

ICH E6(R3) emphasizes the importance of fit-for-purpose systems, built-in quality, data integrity, and proactive risk-based approaches to trial oversight. ICH E8(R1) reinforces the need for operationally feasible study designs and efficient data collection—goals central eSource inherently supports. Far from conflicting with regulatory expectations, central eSource operationalizes them. Sponsors retain responsibility for data quality and oversight, while investigators maintain control and access to data, fulfilling their compliance obligations. Ultimately, central eSource is not just a novel efficiency tool—it is a forward-looking, regulation-aligned strategy for embedding quality and compliance into every layer of trial execution, setting a new standard for modern clinical research.