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Electronic Trial Master File-eTMF

ELECTRONIC TRIAL MASTER FILE – eTMF

The Trial Master File (TMF) is an essential part of managing clinical trials in a regulated environment. Moving to a purpose-built web-based system – an electronic Trial Master File (eTMF), allows for ongoing surveillance of the TMF contents to ensure compliance and audit readiness throughout the trial.


Trial Documentation made better

McDougall manages your trial documents with the same sophistication as it manages your data. Using accepted standards – i.e. The Trial Master File Reference Model (eTMF-RM), or your custom document architecture, certified document managers work with you to document your unique needs in the eTMF Plan.

 

The resulting eTMF validated repository:

  • Provides access control – from ‘read-only’ (only view the reports) to full rights to upload documents and easily ‘file’ them via easy to use meta data fields.
  • Documents progress through a Sponsor-driven QA/QC lifecycle until approved
  • All documents can be monitored through the lifecycle with pre-programmed views, email alerts and status reports to ensure ongoing audit readiness
  • Navigation is intuitive and familiar and is fully integrated with your Outlook e-mail system, not only for notifications, but for document retrieval and filing.
  • At the end of the trial, the completed approved and fully documented eTMF can be exported electronically to easily integrate into your submission software
  • McDougall can also arrange for long-term digital archiving options if requested.

Trial documentation made better, through ongoing transparency and validated processes. Managing your research information is what we do – and we do it very well.

 


REQUEST eTMF INFORMATION

Easily schedule a call, request pricing or a demo to learn more about how McDougall Scientific’s eTMF solution can impact the management of your Clinical Trial.



CONTACT

McDougall Scientific

789 Don Mills Road, Suite 802, Toronto, Ontario M3C 1T5 Canada
Phone: (416) 424-2092

McDougall Scientific

Providing over 30 years of quality service, McDougall Scientific is one of the most experienced Contract Research Organizations around. We look forward to speaking with you about your Clinical Trial needs.

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