White Papers

Understanding the Humans of the TMF

Evaluating TMF stakeholder attitudes to achieve inspection readiness. Any solution to the problem of TMF inspection readiness must consider more than just the hardware and software of the eTMF, but must also consider how electronic tools augment the human roles, processes, and relationships that author the narrative within each TMF. This whitepaper, utilizing original survey…

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How to Apply the Golden Rule of Research to Your Trial Master File

The Trial Master File (TMF) is the foundation of every clinical trial, and a strong foundation is essential to the overall health and stability of any clinical trial. The Golden Rule in clinical research (which also applies to the TMF) is, “If it’s not written down, it didn’t happen.” Click here to read the White…

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