Sponsors and CROs accelerate move to modernize and speed study execution
There is an industrywide drive to streamline trial processes and systems for better study visibility and collaboration, according to the Veeva 2019 Unified Clinical Operations Survey, one of the largest-ever surveys of clinical operations professionals.
New research from Veeva Systems (NYSE:VEEV) finds that all (100%) respondents surveyed report the need to improve information exchange among study partners. On average, they utilize at least three methods to share trial data and documents among sponsors, CROs, and sites, with email as the primary tool. Majorities say the move to streamline information exchange is driven by the need to reduce manual processes (71%), improve collaboration (66%), and increase visibility and oversight (64%) during trials.
Nearly all sponsors and CROs (99%) say they also need to unify clinical applications for greater visibility (70%) and easier collaboration (61%). Many of the challenges in managing trials stem from siloed processes and systems that prevent a complete view of study progress and slow trial execution. Integration (68%) and reporting (57%) are the top two issues cited – both are the direct result of clinical system silos.
Improving Study Start-up to Speed Trial Execution
Study start-up is one of the clinical areas with the most potential to improve trial efficiency and speed. 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 are increasingly adopting purpose-built study start-up applications to speed cycle times. Nearly one-quarter (23%) of respondents are now using newer, purpose-built study start-up applications.
Findings show that the majority cite faster study start-up times (71%) as the primary driver to improve study start-up processes. Half of respondents (50%) say easier collaboration during study start-up is also an area of improvement, highlighting the importance of collaboration in driving clinical trial efficiency and speed.
Steady Adoption of Advanced Clinical Applications
Over the past several years, sponsors and CROs have steadily adopted function-specific applications to improve study execution. The industry is modernizing its processes and systems in major clinical areas such as eTMF and are seeing positive impact. Sponsors and CROs, however, report challenges in other areas such as CTMS because of the prevalence of legacy systems.
Nearly all respondents (95%) say they need to improve the use of CTMS in clinical operations. For most, better analytics and reporting (68%) and increased visibility (60%) are among the primary reasons. Roughly half of sponsors and CROs (48%) also say easier collaboration is a top driver, underscoring the importance of streamlining communication and information sharing during execution.
The number of respondents using purpose-built eTMF applications has tripled since 2014. At the same time, the use of general-purpose methods to manage TMF processes has decreased, indicating the continued move from TMFs that act as static repositories to store and archive documents upon completion to modern purpose-built eTMF applications that enable more ‘active’ trial management. Those using purpose-built eTMF solutions report improved ability to maintain a constant state of inspection-readiness (60%) and visibility into TMF status (58%).
“There is a significant industrywide opportunity to improve study visibility and partner collaboration to speed trial execution,” said Jim Reilly, vice president of Vault Clinical. “As more sponsors, CROs, and sites focus on streamlining clinical processes and systems, drug development will become more efficient and stakeholders will be better aligned throughout the trial lifecycle.”
The Veeva 2019 Unified Clinical Operations Surveyexamines the life sciences industry’s progress toward a unified clinical environment by gathering the experiences and opinions of 461 clinical operations professionals from around the globe. The annual research examines 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.
The full results of the Veeva 2019 Unified Clinical Operations Surveywill be presented at the DIA 2019 Annual Meeting on June 24 at 1:00 p.m. in Innovation Theater 1 in the exhibit hall.