Last week we reviewed the Top 10 cost-saving benefits of eTMF. This week will be examining the top 10 ways an eTMF can increase visibility.
Electronic Trial Master Files Increase Visibility
Poor quality / incorrect documents can be quickly discovered and repaired
Content gaps in required documents, version control, expired documents are readily surfaced
Any users struggling with proper TMF use can be quickly identified, retrained and supported
Milestones can be managed for site activation in order to trigger drug shipment; site status can be updated by the progress of milestones
Broader TMF health views via dashboard status reports: sites, countries, % complete, etc.
Automatic notifications / task lists make team members aware of eTMF next step to-dos
Search allows content to be actionable instead of static and unavailable
Sponsors have on-line oversight for CRO-delegated tasks
Quality personnel have on-line access for audits
Leveraging the information in the electronic trial master files as part of your larger, integrated Clinical Architecture will improve operational decision making, and reduce compliance issues from redundant manual entry across systems
Have you fully realized any of these visibility benefits in your eTMF, or have you embedded them in your future state plans? What about the benefits for time or costs?
Do you have any other ways in which implementing an eTMF has increased visibility? Were there situations where eTMF obscured data? Share your experiences with others so that we can all more accurately predict the future-state with eTMF.
We know that not all eTMFs are created equal. Benefits must be identified and quantified for your organization as a critical component of TMF Maturity modeling when embarking on the road to new or improved eTMF.
See you next week for our wrap up: All Star Top 10 eTMF benefits!
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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.