Electronic Trial Master File (eTMF)

The Trial Master File is a structured set of files used by sponsors and CROs to demonstrate proof of regulatory and ethical requirements for conducting clinical trials. It includes documentation of the following items:* Regulatory and ethical requirements for the trial* Data management plan* Quality control procedures* Clinical protocol* Statistical analysis plan* Safety reporting plan* Protocol deviations* Other relevant documentationThe Trial Master File is designed to provide an audit trail of the entire clinical trial lifecycle from start to finish.

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    Why trust Agatha Life during your clinical trials?

    Every day, more than 200 companies trust Agatha to manage their clinical trial documentation
    Mablink
    Gustave Roussy
    Beyond Spring
    Clinical Services
    NS Pharma
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