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Beyond Compliance: How Sponsors Can Drive Success with Central eSource at Investigator Sites

Beyond Compliance: How Sponsors Can Drive Success with Central eSource at Investigator Sites

Running efficient, high-quality clinical trials is paramount in drug development. Too often, sponsors and CROs face opposition when evaluating tools that defy the status quo, thinking that regulatory guidance does not support novel and innovative methods in clinical research.

Luckily, your experts from CRIO have scrutinized relevant regulations and guidelines to debunk just that.

We’ve analyzed ICH E6(R3), ICH E8(R1), and 21 CFR 312 to provide the reader with a clear understanding on how these regulations align with the central electronic source (eSource) approach. Central eSource is the concept of providing clinical research sites with centrally developed protocol driven eSource forms to ensure consistent and compliant data collection that also enables centralized monitoring and better sponsor oversight, while at the same time reducing site burden.

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Beyond Compliance
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