Veeva 2018 Unified Clinical Operations Survey

Unifying clinical applications is an industrywide priority

See new results from one of the industry's largest, global clinical operations surveys.

The report includes research and analysis on the following topics:

  • The use of unified solutions in improving study execution
  • The move towards more active TMF management
  • Streamlining study start-up
  • Improving clinical trial management processes
  • The use of metrics in driving performance improvements
Clinical Operations Leaders Are Taking Action to Unify Their Clinical Landscape

Findings show the industry is taking action to unify their clinical trial systems and drive end-to-end processes for better visibility and improved study execution. Nearly all (99%) respondents report the need to unify clinical applications, and 87% say their organizations have, or plan to have, an initiative in place to do so.

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“The life sciences industry sees a significant opportunity to run far more efficient and effective trials,” said Jennifer Goldsmith, senior vice president of Veeva Vault. “As organizations continue down the path toward a unified operating model, trial process will be transformed for greater visibility and improved trial execution across the clinical lifecycle.”
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A Unified Clinical Environment Increases Visibility

Better visibility is a top driver for unifying clinical applications for 77% of respondents. Over half of respondents cite faster study execution (67%), improved study quality (62%), and increased productivity (51%) among the primary reasons to unify their clinical applications.

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Industrywide Move to More Active TMF Management

The number of organizations now using an eTMF application has quadrupled since 2014. Half of sponsors (50%) now use a purpose-built eTMF application versus 13% in 2014, and 31% in 2017. The increase in the use of eTMF applications is matched by a sharp decline in the use of content management systems, signaling a shift away from general-purpose methods used in ‘passive’ models, towards ‘active’ TMF management.

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How does your TMF compare to the industry? Complete this short self-evaluation to benchmark the state of your organization’s TMF and gain insight into how active TMF management can improve inspection readiness and trial performance.
Benchmark your TMF
The Use of Metrics in Driving Performance Improvements

Organizations that use metrics (77%) report fewer challenges with clinical operations and are four times more likely to have programs in place to unify their clinical applications than those not using metrics. Those that have programs in place to unify their clinical landscape are also more likely to use operational metrics to measure performance, manage risk, and implement process improvements.

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Streamlining Study Start-up Is A Top Priority

Consistent with the aim on improving study execution, study start-up is a priority focus. The data shows that 83% of organizations have an initiative underway, or will within the next year or more, to improve study start-up processes.

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Improving Clinical Trial Performance

All respondents say they want to improve the use of CTMS in study operations. CTMS system issues are a limiting factor for 84% of respondents. The vast majority have CTMS applications that can’t fully support a range of key functions including governance and oversight (89%), resource management (88%), and issue and task management (86%).

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The industry sees tremendous opportunity to transform their operations by unifying their clinical environments. The change underway will enable the industry to better manage the growing complexity of trials, improve compliance, and leverage insights across the full trial lifecycle to accelerate time to market.
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