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Survey: Universal CRO need to have unified clinical model

Wednesday, September 6, 2017

According to a global industry survey from Veeva Systems, CROs are leading an industry-wide shift to modernize clinical systems and streamline end-to-end trial processes. The Veeva 2017 Unified Clinical Operations Survey: CRO Report reveals that CROs are making progress in moving away from manual processes and legacy systems and increasingly adopting purpose-built clinical applications. However, all CROs surveyed report the need to unify their clinical applications, including their CTMS, EDC, and eTMF, to speed study execution, reduce cost and improve study quality.

Overall, CROs utilize more clinical applications than sponsors to manage their trial processes, with 50% of CROs using five applications or more compared to 38% of sponsors. Among all clinical applications, EDC (86%) is the most commonly used among CROs, followed by eTMF (62%).

However, application and process silos are creating significant difficulties, with nearly three quarters (72%) of CROs reporting integration of multiple applications as the biggest challenge they face with their clinical solutions.

In fact, nearly all (96%) CROs say challenges with their current CTMS application limit their ability to improve clinical operations. Integration with EDC (50%) is one of their most frequently reported issues, and two-thirds of top CROs (64%) say integration with eTMF is also a challenge.

Despite these challenges, CROs are modernizing their clinical environments at an accelerated pace compared to sponsors. More CROs (42%) use a purpose-built eTMF application versus sponsors (31%) and a third (32%) of CROs are adopting study start-up applications faster, compared to only 9% of sponsors.

The use of data and metrics is key to improving trial processes. This is an area where CROs are leading the industry, as the survey found that a third (35%) of CROs extensively use eTMF data compared to a quarter (27%) of sponsors. CROs that extensively use data to improve trial processes reported greater benefits, including better visibility into performance metrics (59%) and automated tracking and reporting of documents (65%).

However, one third (30%) of CROs still report challenges with clinical data being tracked outside of clinical systems. This is likely due to technology limitations such as system silos and poor integration. Consequently, reporting across multiple applications is one of the biggest challenges CROs face when asked about their use of clinical systems. That is why half (54%) of CROs report the need for better visibility.

“There is an overwhelming need to address the application and process silos that are holding the industry back,” said Jennifer Goldsmith, senior vice president of Veeva Vault. “CROs are taking significant steps to modernize the clinical environment and playing a pivotal role in moving the industry toward a unified operating model.”

The Veeva 2017 Unified Clinical Operations Survey: CRO Report examines CROs’ progress in unifying clinical operations by gathering the experiences and opinions of 50 CRO respondents from around the world. This research examines the drivers, barriers, and benefits of a unified clinical operating model and tracks the move to streamline clinical systems and processes.

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