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.
PhlexTMF for Viewing answers that pressing need with secure, compliant, cloud-based TMF storage for closed and locked studies.
Note: Phlexglobal customers already have this capability as part of the PhlexTMF eTMF software.
April 21st, 2021
10am Eastern / 3pm GMT / 4pm Central Europe
It’s a common situation: Your drug study is closed, you need inspection-ready access to the Trial Master File, but your CRO is ready to get the TMF out of their system and wants to send you a zip folder full of documents. What do you do?
In this session, we will 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|
Many documents still printed out - even if the CRO is using an eTMF
|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|