Understanding True eTMF Requirements

Meeting Today’s Expectations of Industry and Regulatory Agencies

Download Whitepaper

By clicking ‘Submit’ button, you are agreeing to opt-in to communications from ArisGlobal and use of the above information for ArisGlobal products, news & updates.

Note: You can unsubscribe to email communication from ArisGlobal any time.

Life sciences companies must meet the expectations of regulatory agencies in their oversight of the design, conduct, recording and reporting of clinical trials. The Trial Master File (TMF) is the cornerstone of what is examined by inspectors to demonstrate the compliance of the sponsor, trial monitor and the investigators with Good Clinical Practice (GCP) standards and regulatory requirements.

This white paper explores why the life science industry continues to struggle with the handling and storing of essential documents and the benefits that can be made from unifying eTMF solutions with eClinical solutions.

Download this paper to learn about:

  • The purpose of the TMF and the rise of standards for greater understanding of what it should contain
  • Critical inspection findings and the need for mature electronic trial master file solutions
  • Addressing compliance and other issues including electronic signatures, as required for 21 CRF Part 11, the process for destruction of documents and managing delocalized eTMFs
  • Overcoming the challenges with the right solution that keeps the eTMF up to date through close integration with CTMS