Why do you need to effectively manage your TMF?

Trial Master File (TMF) is the common term for a sponsor’s regulatory-required essential documents for a clinical trial. A quality and complete TMF is cornerstone to demonstrate clinical trial execution, and the key success factor for health authority GCP inspection. An optimized and actively managed TMF can speed study start-up, deliver signals for required trial actions, and support overall trial operations. Quality TMFs also streamline business development activity in both acquisitions and divestitures. Conversely, TMF quality gaps result in health authority observations, warning letters, delayed product marketing approvals, fines, and negatively impact the value of M&A activities.

Why CGI?

Choosing the right partner for your TMF project is critical to successfully meet your goals. CGI is the right TMF partner for four simple reasons:

  • We have the right team - Our team members have extensive and diverse TMF and operations experience which they leverage for client engagements
  • We have the right experience – Our team has worked with more TMF clients and platforms than any other consulting firm
  • We have the right insights – We stay on the cutting edge of innovation through partnership with all eTMF vendors and membership in industry consortiums
  • We have the right solutions – We focus on your goal, and deliver compliant solutions to fit your need, including process redesign, eTMF implementation, governance, record processing, inspection readiness and recovery