Electronic Trial Master Files Save Sponsors and Investigators Money
Reduce costs of site activation – no more need to print, copy and courier initiation documents back and forth with sites
Speeding up site start-up reduces the total clinical trial execution time, which saves resource dollars
Verifying site docs remotely can reduce the amount of travel costs and time spent at the site
Avoid fines levied by Health Authorities for GCP compliance failures
Repetitive tasks can be outsourced to lower cost resources
Reduce printing, storage, and real estate costs – no massive file rooms of folders / binders
Reduce paper printing and signing documents with electronic or digital approvals
Save with automated trial processes (e.g. product shipment green light)
Eliminate expensive, laborious, late game paper file rescues
Improve operational status reporting – remove the manually intensive merging of tracker spreadsheets for upper management status reporting
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.
Have you fully realized any of these cost (or last week’s time) savings 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.
Stay tuned for the next posting: Top 10 clinical trial master file eTMF benefits in transparency!
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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.