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| home > white papers > Points to Consider When Developing a TMF (Trial Master File) Strategy - Phlexglobal Ltd |
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 WHITE PAPERS |
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Phlexglobal Ltd
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Points to Consider When Developing a TMF (Trial Master File) Strategy
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Many organizations are currently outsourcing clinical trial activities
to one or more contract research organizations (CROs). This strategy
enables companies to leverage specialized expertise and take advantage
of flexible resourcing throughout the conduct of a clinical trial.
Outsourcing minimizes the costs of recruiting experts, building a team
and maintaining an infrastructure. However, it can also add complexity
as the organization looks to meets its compliance obligations regarding
clinical trial documentation.
The documentation referred to in
Article 15(5) of Directive 2001/20/EC as the trial master file shall
consist of essential documents, which enable both the conduct of a
clinical trial and the quality of the data produced to be evaluated.1
This essential study specific documentation is also known as the TMF. As
organizations try to minimize their reliance on paper files, the
electronic TMF (eTMF) has emerged. A current industry initiative to
standardize the organization of this content is known as the TMF
Reference Model. This model is helping standardization efforts across
paper and electronic systems.
As companies implement outsourcing
strategies, CROs and sponsor organizations look for a common foundation
on which to build their TMF capabilities. The following paper outlines
some of the challenges organizations face when outsourcing clinical
trial activities to multiple contract research organizations and a
strategy to facilitate partnering and management of trial information
between sponsors and CROs.
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