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
CRIO’s regulatory experts reviewed ICH E6(R3), ICH E8(R1), and 21 CFR 312 to examine how Central eSource aligns with the principles of Good Clinical Practice. This white paper breaks down our findings into actionable insights for sponsors and CROs navigating modern clinical trial operations. In this white paper, you will find how Central eSource:
- Ensures Reliable Results with Fit-for-Purpose Systems
- Empowers Investigators and Fulfills Responsibilities
- Enables Sponsor Oversight and Quality Management
- Incorporates Quality by Design (ICH E8(R1))
In an era where trial efficiency, participant safety, and data reliability are paramount, central eSource is not just acceptable—it’s the embodiment of Good Clinical Practice for the next generation of global trials.
Download it now to see how Central eSource supports site compliance, enables real-time monitoring, and enhances quality in every stage of the trial lifecycle.