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Advanced eTMF systems offer CROs advantages

Sunday, February 15, 2015

It’s no secret competitive pressures are mounting for CROs. Life sciences companies need to get to market faster and more efficiently. Although sponsors are actively investing in CRO partnerships, they want to establish fewer, more strategic partners to improve efficiency. As a result, the financial stakes for CROs are high. Those CROs that find a way to offer higher Trial Master File (TMF) quality, improved collaboration and increased inspection-readiness while lowering costs undoubtedly will have an advantage.

Advanced, cloud-based electronic Trial Master File (eTMF) systems give CROs the technology foundation needed to provide real-time visibility, increased control and improved compliance throughout the clinical trial process. By eliminating the paper-based and file share systems that lead to costly delays, errors and inefficiencies, CROs can establish a foundation for sustainable collaboration with sponsors that will serve them well moving forward.

According to a 2014 Veeva survey, one in five CROs is using a purpose-built eTMF and reaping the benefits. Those reported in inspection-readiness after converting to an eTMF system were particularly telling; 76% of CROs saw an improvement in missing or misfiled documents; 72% cited reductions in duplicate documents; and progress in reducing the number of incomplete and expired documents were cited at 65% and 62%, respectively. Improved collaboration with other CROs (49%) and sites (45%) also were reported.

Ironically, the CROs that have gone paperless reported greater benefits and cost savings than sponsors. Sponsors benefit from real-time visibility, improved quality and inspection readiness, but CROs benefit from a scalable model they can leverage across hundreds of trials and thousands of sites.

By tapping the technology of advanced eTMF systems, CROs can more effectively do their job while reducing costs, making them a stronger competitor and more viable future partner.


Written by Guest Writer Jennifer Goldsmith. Goldsmith, vice president of Vault at Veeva Systems, is a pioneering thinker with a history of leadership in life sciences and technology. She spearheaded development of the first cloud-based regulated content management solution for the life sciences, the Vault product line, launched in 2011. She has worked in the life sciences for more than 15 years, across the value chain from early R&D to commercial operations.

This article was reprinted from Volume 22, Issue 02, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns  focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact editorial@centerwatch.comSubscribe >>

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