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How electronic trial master files are streamlining the clinical trial process

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) defines a trial master file (TMF) as “the story of how a clinical trial was conducted and managed”. This means that it must contain all the essential documents for a regulator and inspectors to review and evaluate the conduct of a clinical trial.

GlobalData pharmaceutical technology writer Allie Nawrat looks at how electronic, cloud-based systems are replacing the old ‘paper chase’ methodology.

Increasingly pharma companies and charities carrying out clinical trials are embracing electronic TMF (eTMF) approaches in an attempt to drive cost savings and efficiencies in the back-end of the drug development process. However, the benefits of eTMF go even further.

Cancer Research UK (CRUK) head of clinical operations and data management Stephen Nabarro implemented Veeva Vault eTMF two years ago.

Nabarro tells GlobalData: “It’s easy to implement the technology and to write the processes of what people should be doing, but it’s hard to get people on board. The end users don’t think about how this is better in the eyes of the auditor or how it is saving the charity money.”

But he notes there are clear efficiencies of using an electronic version; everyone knows where the “single source of truth” regarding guidance about the drug and its clinical development is, thereby “ensur[ing] patient safety and data integrity.”

Adding: “You can instantly get a report or log from the system [and because the eTMF is web-based] you can access it from any computer anywhere in the world.” This means embracing digital can really drive quality on a permanent basis; we are always inspection ready as a result.

He concludes that in the future, hopefully, CRUK, and the industry as a whole, will leverage technology to drive further efficiencies in delivering clinical trials – perhaps by creating at least semi-virtual trials where patients are empowered to use technological solutions during their participation in trials.

Editor Details

  • Company:
    • MHRA
  • Name:
    • MHRA
Last Updated: 27-Nov-2019