ARTICLES BY KEN KEEFER
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ICH E6(R3) And Defining What Is Critical To TMF Quality4/9/2024
By applying Quality by Design to clinical trials, sponsor companies can rise to meet the elevated role and importance of the TMF in the face of ICH E6 (RF3).
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TMF Reference Model Affiliation With CDISC Could Improve TMF Interoperability3/20/2023
There is a growing desire within the clinical trials industry for better data integration — not just to help regulators, but also to help sponsors manage trials more effectively. The recent affiliation of the TMF Reference Model with the Clinical Data Interchange Standards Consortium (CDISC) may become key to making this possible.
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