Clinical operations are heading for a unified digital platform, but how fast?

At this year’s DIA Annual Meeting (Chicago, June 18-22), Veeva released the results of its latest global survey of clinical operations managers (respondents were two-thirds trial sponsors, and lesser numbers from CROs and consultants). The picture painted by the Unified Clinical Operations Survey is one where the number of software platforms are expanding, but the number of operational problems are keeping pace with that expansion. A software platform that could bring interoperability and standardization to these functions is desirable, but it’s an open question whether the various vendors in this field have the wherewithal and customer support to do so.

The survey notes that most digitization efforts in clinical trials started with electronic data capture (EDC), now in use by 82% of respondents (amazingly, manual process are still in use industry-wide). Clinical trial management systems (CTMS) and electronic trial master files (eTMFs) trail behind, with a variety of other tools for trial startup, outcomes assessments, interactive voice response and the like. Respondents indicate that spending on CTMS will be rising by 15% annually for the next several years; however, integrating EDC and TMF reporting with the CTMS are near the top of ongoing problems with these systems.

Veeva itself started in the clinical arena with a eTMF offering, but has since expanded to the Vault Clinical Suite, which includes CTMS and study startup among other elements; the Vault platform is multitenant cloud-based and intended to streamline interaction among the various applications. At DIA, Veeva announced major client wins with Regeneron and at least four other clients for the recently announced CTMS offering. “The industry’s transition toward a unified clinical environment is being driven by its need to address the silos legacy systems have created,” said Jennifer Goldsmith, SVP of Veeva Vault. “Life sciences companies are taking steps to streamline their end-to-end processes and systems with modern applications so they can execute faster and improve visibility across their study portfolios.”