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NAMSA Replaces Manual, Paper-based System to Transform Its TMF into a True Strategic Asset
PLEASANTON, CA – March 22, 2016– NAMSA, a leading global medical research organization, partnered with Veeva Systems to replace its paper-based system for managing clinical trial documents. Live with Veeva Vault eTMF in less than eight weeks, NAMSA gained real-time, global access to vital trial data for improved inspection readiness and efficiency.
Before Vault eTMF, NAMSA’s clinical trial documents were manually entered into a storage system after trials were completed. Recognizing a more active approach to TMF management would increase compliance and speed, NAMSA began its search for a new solution. “In order to better serve our clients’ TMF needs, we required an electronic solution that would allow us to proactively manage and collaborate on TMF documents throughout the study,” said Jennifer Mischke, director of consulting and data services for NAMSA. “The industry is just starting to recognize the strategic value of a well-managed TMF, so we wanted to get ahead of the curve.”
NAMSA selected Vault eTMF to enable real-time inspection readiness, provide visibility into study status to its clients, and increase overall TMF efficiency. Vault eTMF’s workflows ensure adherence to standard operating procedures (SOPs) and correct filing of all documents for a higher level of TMF quality. Further, Vault eTMF supports all versions of the TMF Reference Model, including version 3.0. The dashboards and reporting features allow NAMSA and sponsors to track study progress overall and drill into individual site and document status as needed.
Vault eTMF allowed NAMSA to quickly experience the benefits of collaboration on TMF documents with sponsors, sites, clinical laboratories, and other partners – with minimal training. NAMSA also streamlined its clinical trials by giving all global teams real-time access to TMF documents. Mischke explained, “Vault eTMF reduces the time we spend handling files by at least one-third, which lowers costs and frees staff to focus on more value-add work for clients. As important, our TMF is always inspection-ready, saving additional time and improving productivity.”
NAMSA is not alone in seeing marked improvements in inspection-readiness after adopting an eTMF solution. More than half of respondents (57%) in the Veeva 2015 Paperless TMF Survey: Annual CRO Report reported improved audit- and inspection-readiness as a result of eTMF adoption. In fact, almost all surveyed organizations that use an eTMF reported improvements in the number of missing documents (92%); misfiled documents (89%); duplicate documents (86%); incomplete documents and/or missing signatures (84%); and expired documents (81%).
“Life sciences organizations demand a high level of coordination on TMF activities. Cutting-edge service providers, like NAMSA, that provide sponsors direct access to the TMF with full visibility into study status can deliver higher quality clinical documentation and services with fewer resources,” said Michael Burton, Veeva director of CRO Alliances. “It’s exciting to see NAMSA’s transformation as a result of actively managing its TMF in real time with Vault eTMF.”
NAMSA is a Medical Research Organization (MRO), accelerating product development through integrated laboratory, clinical and consulting services. Driven by our regulatory expertise, NAMSA's MRO® Approach plays an important role in translational research, applying a unique combination of disciplines-consulting, regulatory, preclinical, toxicology, microbiology, chemistry, clinical and quality-to move client’s products through the development process, and continue to provide support through commercialization to post-market requirements, anywhere in the world. For more information, visit www.namsa.com.
For more on Veeva Vault eTMF, visit: veeva.com/vaultetmf
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