Few CROs offer compliant maintenance of the Trial Master File following study close closeout, usually returning the eTMF on unsecure and hard-to-track media such as USB drives or even printed out. These Trial Master Files are difficult to review and inspect, and force sponsors to keep their own study documents separate. Sponsors had limited options for compliance with regulatory requirements – until now.
The graphic below was inspired by an MHRA presentation from 2018 by Andy Fisher.
Note: Phlexglobal customers already have this capability as part of the PhlexTMF eTMF software.
In this session, we explore an innovative new way to ensure your TMF stays secure while remaining accessible to audits and inspectors so you can focus on getting your drug to market and not on finding documents.
| Usual Industry Approach | PhlexTMF for Viewing Provides | |
| TMF is often returned to sponsor on unsecure and hard-to-track media such as USB drives. |  |
Fully compliant, secure, cloud-based storage |
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Many documents still printed out - even if the CRO is using an eTMF |
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Easy for sponsors to review at any time from anywhere |
| Difficult for sponsors to review | |
Facilitates streamlined access for inspectors, which has become an expectation among regulatory agencies |
| Sponsor documents are typically separate | |
Sponsor documents can be added directly to PhlexTMF for Viewing |
Introduction We have been on a journey you and me, we started off by understanding the purpose of a clinical trial and the multiple phases to get products to market. We then looked at the Trial
Introduction Awww it warms my heart you came back to read the third blog. I hope you are finding these helpful, don’t forget to send any of your feedback or questions to rtjones@phlexglobal.com. We
Introduction You came back, great! I hope you enjoyed our first blog in this series which was all about the basics of a clinical trial. In this blog we are going to get into the Trial Master File,