By now, you have probably heard of electronic Trial Master Files (eTMFs) and how they are gaining widespread adoption within the life sciences industry. You may have attended conferences, webinars, or simply talked to vendors who are telling you eTMFs will change the way you run clinical trials.
Too often we get hung up on talking about how revolutionary eTMFs are without examining the business benefits. In order to gain funding and project support for implementing a new or improved eTMF, you need to identify the benefits for your organization, and then measure your project’s results to those benefits in the execution. In order for users to adopt a new or improved eTMF you need to convince them that the benefits outweigh their perceived pain of change.
So, what are the benefits of a robust eTMF? They can be found in three main categories, each of which include both organization and end user benefits:
For the next few weeks, we’ll outline the top ten benefits in each category, and finish week four with our personal all-star top ten favorites. Let’s kick it off with the top 10 time-saving benefits of eTMF.
Electronic Trial Master Files Save Sponsors and Investigators Time
Audit / inspection preparation happens just-in-time, not months or years after content is filed
Site activation / initiation documentation is distributed with a few keystrokes
Content updates push to all parties with a single posting (e.g. amended protocols)
During Study Close-out, less time and effort for final file reconciliation
Content flow for Regulatory Submissions can be sped through automation
Reduced travel time to sites to inspect files (targeted monitoring)
Reduce time to establish a new clinical site / investigator
Less time filing paper at both site and sponsor
Cycle time to complete documents and tasks is reduced
Search and retrieval of information from TMF is much faster electronically.
Have you fully realized any of these time benefits in your eTMF, or have you embedded them in your future state plans? Do you have any other ways in which implementing an eTMF has saved you or your company time? Were there situations where eTMF adversely impacted timelines? Share your experiences with others so that we can all more accurately predict the future-state with eTMF.
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Fran joined Paragon Solutions in April 2012, and is currently Associate Director in the Clinical and Regulatory Optimization practice. She previously worked at Genzyme / Sanofi for more than a decade, and has more than 20 years of academic and industry clinical and process expertise. She presents frequently at industry conferences, and is a member of several industry initiatives, including TMF Reference Model, OASIS eTMF Interoperability, and ACRES.