By Jennifer Goldsmith, VP of Vault, Veeva Systems
According to a 2012 TMF Reference Model survey of 500 sponsors, CROs, and consultants, 28 percent of respondents are currently using an electronic TMF (eTMF) while 57 percent are in the process of planning, building, or evaluating an eTMF – a twelve percentage point jump since 2010.1 Most eTMFs today are used like electronic filing cabinets, merely a scanned archive of TMF information. Only a small fraction leverage the eTMF’s ability to deliver business insights that provide true strategic value to the organization.
Consider the advantages of knowing which sites perform best in which therapeutic areas, or how protocol amendments affect outcomes across multiple studies. Obtaining these types of eTMF-derived insights, however, is not a given. The recipe for leveraging your eTMF as a strategic asset includes four key ingredients, each of which is essential.
Step 1 – Get Fully Digital
Going electronic is the first step to harnessing an eTMF’s full potential. Organizations must transition from sending and storing paper documents to authoring and processing electronic documents. Replacing paper provides significant early gains that can speed clinical trial startup and improve inspection readiness – including the ability to find information quickly for inspectors and collaborate with partners efficiently. Without electronic documents, moving to the next step is almost impossible.
Step 2 – Define Collaborative Processes
Many organizations are still using eTMFs as an electronic filing cabinet while maintaining paper-based processes, such as printing and scanning documents. With electronic processes, individuals no longer send paper to a central Records Management team. Rather, the responsibility for filing documents into the eTMF is distributed across the clinical ecosystem, making it critically important to assign and communicate ownership of TMF documents. When all parties have defined roles, sending files electronically and ensuring task completion is quick and efficient. A cloud-based eTMF offers the highest level of collaboration, with all players easily accessing trial documentation in real time. As clinical trials grow more complex, the ability to come together and work effectively with multiple players is crucial – and a globally accessible eTMF can provide that common ground.
Step 3 – Build a Repeatable Framework
When processes are codified as workflows, templates, and configurations within the eTMF application, you build a repeatable framework and eliminate the variability that causes error and delay. Imagine trying to complete a task with a team of individuals who each have a different word for every document involved. At best, it’s difficult. At worst, it’s impossible. But this is exactly what happens in clinical trials every day. The DIA TMF reference model provides a common nomenclature that all participants can understand and support. Plus such a repeatable framework will operationalize standard operating procedures, building them directly into workflows and lifecycles. Standardized processes improve communications between sponsor and CROs teams around the world, dramatically increasing operational efficiency. While these benefits are significant in their own right, they are also the precursors to gaining strategic value.
Step 4 – Gain Valuable Insights
Next-generation eTMFs give organizations 360-degree visibility into trial activities. Organizations can assess completeness, accuracy, and timeliness by both task and functional area, allowing managers to track critical metrics while the study is in progress so delays or mistakes are caught early. Dashboard metrics help trial managers keep fellow team members on task. Tracking contract execution and consumption of site training materials, for instance, can give organizations the insight they need to get sites started more quickly. Further, in the case of cloud-based eTMFs, the system houses data from all parties, and all studies, in one place. With consolidated data, organizations can look at trends and quality metrics across functional areas, therapeutic areas, partners, or sites, to inform business decisions or process improvements.
Organizations can no longer afford to chase papers between departments, CROs, and distant sites: they need a point of convergence and collaboration. A truly sophisticated TMF is more than just a record. A convenient way to file documents, yes, but that’s just scratching the surface. Fully employed, the eTMF can be a strategic asset that not only guides and automates the collection of documents to reduce costly errors but also reveals insights that lead to long-term process improvements that streamline the entire study process.
About the author:
Jennifer Goldsmith, vice president of Vault at Veeva Systems, is a pioneering thinker with a long history of leadership in life sciences and technology. Goldsmith spearheaded the development of the first cloud-based regulated content management solution for the life sciences, the Vault product line. Goldsmith oversaw the vision, implementation, and marketing of Vault, which is revolutionizing the life sciences industry. Organizations that had been storing information on aging on-premise systems now have the opportunity to utilize a modern consumer web paradigm designed to help speed time-to-market for new drugs. Vault’s industry cloud applications for regulated content management have received widespread acclaim for combining a focus on supporting regulatory compliance with the flexibility of cloud computing.