Welcome! In the last three posts, we have covered our Top 10 benefits of electronic trial master files (eTMFs), going into detail on how:
- Electronic Trial Master Files save time
- Electronic Trial Master Files save money
- Electronic Trial Master Files increase visibility
In our experience with a wide variety of systems, we know that not all eTMFs are created equal. We also know that realizing the benefits is not solely dependent on careful technology selection, but also includes assessment and management of the related changes for process and people. With the right planning and execution, eTMF benefits are within reach of any company. When embarking on the road to a new or improved eTMF, you need to identify and quantify the benefits for your organization. We believe a focus on benefits is a critical component of TMF Maturity modeling and is essential to both executive sponsorship and end-user acceptance.
Since we can take a perfect world, clean slate perspective, we’ll wrap up this series by sharing with you our All Star Top 10 eTMF benefits.
Top Ten All Star Benefits of Electronic Trial Master Files
- Audit / inspection preparation happens just-in-time, not months or years after content is filed
- Content updates push to all parties with a single posting (e.g. amended protocols)
- 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
- Reduce printing, storage, and real estate costs – no massive file rooms of folders / binders
- 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
- Any users struggling with proper TMF use can be quickly identified, retrained and supported
- Search allows content to be actionable instead of static and unavailable
- Leveraging the information in the eTMF as part of your larger, integrated Clinical Architecture will improve operational decision making, and reduce compliance issues from redundant manual entry across systems
What are your top benefits of implementing a new or improved electronic trial master file (eTMF)? Where has your company seen the biggest gains/benefits? Has any anticipated benefit not yet been realized? Share your experiences with others via the comments. And let us know if you have other clinical trial master file Top 10 topics of interest.