“The industry is struggling with legacy technology, disconnected applications, and process silos across clinical operations,” Jennifer Goldsmith, Senior VP of Veeva Vault, Veeva Systems, told Outsourcing-Pharma.com.
In a recent survey of eTMF owners, 49% cited integration between their eTMF and CTMS applications as a key need. According to Goldsmith, Veeva Vault CTMS solves a big need in unifying clinical information, documentation, and processes globally.
“When you combine CTMS with eTMF and Study Startup, that’s a real-game changer for customers that have traditionally struggled to share information between these systems,” she said.
“With the addition of CTMS, now we can provide them a unified clinical suite of applications,” added Goldsmith, which she said is the “the first and only one.”
Demand
The demand for next-generation CTMS solutions is driven by a number of factors. Mainly, there is a lack of real-time visibility into trial or portfolio statuses.
“There is also a lack of confidence in the integrity of clinical operations master data because it lives in so many different systems and is often duplicated from one system to the next,” added Goldsmith.
She also added that there is an inability to view and access clinical operations data from a single system, which makes collaboration between sponsors, CROs, and investigator sites difficult. “This all creates significant limitations in how clinical trials are planned and executed,” Goldsmith said.
Vault CTMS is expected to be available in the first quarter of 2017.