Not Just a Midsummer Night’s Dream: Digital Transformation for Your TMF

Now that summer has come to an end, we are rolling up our sleeves and working hard to solve your most pressing TMF challenges. As part of our mission to ensure TMF success for all, we’re attending two important conferences: The Veeva R&D Summit, September 8th through the 10th in Philadelphia, Pennsylvania, and the Trial Master File & Clinical Document Management Conference, September 10th through the 12th, in Anaheim, California. At the Anaheim TMF Conference, we’re proud that our very own Jackie Morrill, Director of Clinical Operations at LMK, will be speaking on the crucial topic of TMF digital transformation. If you aren’t sure what digital transformation is or what digital transformation means for your TMF, please keep reading—or better yet, if you are able—join us in Anaheim. We’d love to see you there and look forward to discussing your specific TMF challenges.


What is Digital Transformation?

Digital transformation is a simple concept: it means refreshing ideas and processes to take advantage of cutting-edge digital tools. Emerging technologies like cloud computing, IOT (Internet of Things), artificial intelligence, and of course, prevailing technologies like the eTMF, have changed and will continue to change essential document collection. Digital transformation means dispensing the physical (paper documents) and embracing new digital tools. It requires letting go of preconceptions and old habits rooted in the past. The goal of digital transformation is to nimbly harness the power of new digital tools and to orient your team or company to work in harmony with, rather than in opposition to, this ever-growing digital universe.


How Can I Digitally Transform My TMF Today?

In a recent journal article, we discussed how clinical operations professionals are using clinical applications begrudgingly or in parallel with email and Excel. In fact, despite the widespread adoption of electronic data capture (EDC) systems, randomization and clinical supplies management software (RTSM) applications, and eTMF systems, 81%  of respondents to a recent Veeva survey report the ongoing use of manual processes (like spreadsheets and emails) to manage study start-up.[1] 81% of respondents, therefore, most of whom also reported having many digital tools at their fingertips that could manage (or even automate) aspects of study start-up, cannot harness their existing powerful digital tools because their organizations’ antiquated processes have not empowered them to.  

Digital transformation depends on one key term: integration. Even the most advanced TMF system cannot achieve TMF success without the integration of a forward-thinking team and modernized processes. Digital transformation of today’s TMF means integration of disparate clinical applications, teams, tools, and processes to build an intelligent eTMF ecosystem capable of harnessing actionable insights from the data produced by the eTMF and other digital tools. LMK’s experienced TMF professionals know how to most efficiently update your processes and clinical operations philosophy to leverage the digital tools you already have at your disposal—transforming your clinical applications from inefficient liability into a competitive advantage. LMK’s team is also adept at matching eTMF naive organizations with the tools that best suit the size, structure, and goals of their team. Reach out to LMK today to turn your TMF digital transformation dream into a reality!