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Top 10 Advantages of Electronic Trial Master Files: Part 2

By  Fran Ross Fran Ross  on 2013-04-22 06:46:00  |  Featured in  Life Sciences
Fran Ross
Posted By Fran Ross
in Life Sciences
on 2013-04-22 06:46:00

Welcome! As part of Paragon’s continuing series of posts on the top benefits of electronic trial master files (eTMFs), we are examining how:

In the last article we reviewed the Top 10 Advantages of Electronic Trial Master Files around the time-saving benefits of eTMF. This week we will be examining the top 10 financial benefits of eTMF.

Electronic Trial Master Files Save Sponsors and Investigators Money

  1. Reduce costs of site activation – no more need to print, copy and courier initiation documents back and forth with sites
  2. Speeding up site start-up reduces the total clinical trial execution time, which saves resource dollars
  3. Verifying site docs remotely can reduce the amount of travel costs and time spent at the site
  4. Avoid fines levied by Health Authorities for GCP compliance failures
  5. Repetitive tasks can be outsourced to lower cost resources
  6. Reduce printing, storage, and real estate costs – no massive file rooms of folders / binders
  7. Reduce paper printing and signing documents with electronic or digital approvals
  8. Save with automated trial processes (e.g. product shipment green light)
  9. Eliminate expensive, laborious, late game paper file rescues
  10. 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 Ross

Fran Ross

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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.

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