NAMSA Replaces Manual, Paper-based System to Transform Its TMF into a
True Strategic Asset
PLEASANTON, Calif.--(BUSINESS WIRE)--
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.”
About NAMSA
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.
Additional Information
For more on Veeva Vault eTMF, visit: veeva.com/vaultetmf
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About Veeva Systems
Veeva Systems Inc. is a leader in cloud-based software for the global
life sciences industry. Committed to innovation, product excellence, and
customer success, Veeva has more than 400 customers, ranging from the
world's largest pharmaceutical companies to emerging biotechs. Veeva is
headquartered in the San Francisco Bay Area, with offices in Europe,
Asia, and Latin America. For more information, visit www.veeva.com.
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Source: Veeva Systems