The Veeva 2019 Unified Clinical Operations Survey Report examines the life sciences industry’s progress toward a unified clinical operating environment by gathering the experiences and opinions of 461 clinical operations professionals from around the globe. The annual research details the drivers, barriers, and benefits of a unified clinical operating model and tracks the industry’s progress in its move to unify clinical systems and processes and align stakeholders throughout study execution.
Findings show the industry is making progress in unifying clinical systems, streamlining end-to-end processes, and aligning stakeholders to improve trial performance.
- Standalone, eClinical applications, including EDC (88%), eTMF (69%), and CTMS (61%) are now utilized by the majority of sponsors and CROs as they steadily adopt function-specific technologies to support clinical trials.
- Nearly all (99%) respondents report the need to unify clinical applications to achieve better visibility and oversight (70%), faster trials (63%), and easier stakeholder collaboration (61%).
- Consistent with the aim to improve collaboration, all respondents say they want to improve methods of information exchange between sponsors, CROs, and sites. Primary reasons include reduced manual processes (71%), improved collaboration (66%), and better visibility and oversight (64%).
- All respondents report significant challenges with study start-up, likely due to the heavy reliance on manual processes since most (81%) use spreadsheets to manage this area.
- Sponsors and CROs have made progress modernizing major clinical areas such as eTMF to ensure a constant state of inspection readiness (60%) and increase visibility into TMF status (58%).
- Most respondents (95%) cite the need to improve the use of CTMS in clinical operations. Top drivers are improved reporting (68%), increased visibility (60%), and more proactive risk mitigation (58%).
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