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insights LIFESCIENCELEADER.COM 42 JULY 2014 CLINICAL TRIALS J E N N I F E R G O L D S M I T H & L I S A M U L C A H Y eTMFs: Moving From Electronic Filing Cabinet To Strategic Asset M cKinsey identified having a single document repository with workflow management and the ability to track cost, quality, and speed as a core factor for busi- ness transformation. Turns out, McKinsey was onto something. The growing functionality in electronic trial master file (eTMF) applications enables life sciences companies to stream- line many inefficient processes that can slow clinical trials. Moreover, today's eTMFs enable sponsors and CROs to bet- ter track a study's progress by tracking the status and completion of critical docu- ments. Doing so enables both types of organizations to proactively identify oper- ational challenges and avoid costly delays. In fact, advanced eTMF applications can become a crucial source of trial informa- tion and performance insights to help improve and speed clinical development. The eTMF — the electronic compila- tion of documents and other content that chronicle the conduct of a clinical trial — is gaining traction. According to the 2012 TMF Reference Model survey, 27 percent of respondents claim to be actively building or evaluating an eTMF, up from 17 percent in 2010. TMF management has evolved, too, from paper-based files to electronic "filing cabinets" of scanned documents and, today, to purpose-built applications, some of which have even moved to the cloud. Unlike their predecessors, mod- ern eTMF applications provide visibility into trial operations and help ensure that the TMF is always inspection-ready. The wealth of information these applications collect about a study's start-up, ongoing operations, and close-out allows the eTMF to function as a business planning tool. Widespread industry research high- lights how document-centric processes directly impact major benchmarks, such as study start-up and close-out. Paper- intensive processes, such as contract nego- tiations and ethics committee approvals, are top causes of study delay, suggests data from a 2011 global CenterWatch study. Furthermore, a collaborative study on trial start-up conducted by the Tufts Center for the Study of Drug Development reveals that, on average, a Phase 2/3 study takes 16.7 months from protocol approval to 100 percent approved sites initiated. Within this time frame, high volumes of paperwork tied to pre-study visits, site selection, contract negotiations, site ini- tiation, and first-patient visits are generat- ed. And, according to Veeva Systems' 2014 survey of TMF owners (n = 260), 63 percent of respondents say paperless study and site start-up processes would significantly shorten clinical development times. Recognizing the efficiencies that an eTMF application offers an organization is one thing. Transforming an eTMF into a truly strategic asset capable of improv- ing the bottom line is another matter. To extract the full potential of an eTMF, life sciences organizations must take a few important steps with the partner, the application itself, and their own organization. These include: Step 1 – Define the collaborative process among internal and external partners. Step 2 – Build a repeatable framework, outlining what documents are expected, what they are called, and who is responsible. Step 3 – Leverage performance met- rics involving study-related documents to provide visibility and early problem resolution. DEFINING A COLLABORATIVE PROCESS The growing number of trial stakeholders (CROs, trial sites, agencies, committees, patients) has dramatically increased the complexity of assembling the numerous In 2010, McKinsey & Company published a report on the need to reinvent drug development through technologies designed to streamline the clinical trials process. The report recommends implementing technologies that represent a "clean-sheet" or redesigned traditional clinical trial methodology. By J. Goldsmith, L. Mulcahy ETMFS: MOVING FROM ELECTRONIC FILING CABINET TO STRATEGIC ASSET 0 7 1 4 _ C l i n i c a l T r i a l . i n d d 1 0714_ClinicalTrial.indd 1 6 / 2 0 / 2 0 1 4 1 2 : 2 9 : 4 1 P M 6/20/2014 12:29:41 PM