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Contract research organizations (CROs) are making significant progress in advancing the industrywide move to improve clinical trial performance, according to the Veeva 2019 Unified Clinical Operations Survey: Annual CRO Report. The findings from Veeva Systems reveal that CROs are eliminating manual processes and modernizing key areas of clinical trial execution to enhance partner collaboration and improve study performance.
All CROs surveyed cite the need to streamline information exchange among study partners. Today, CROs share trial data and documents with sponsors and sites in multiple ways, many of which are manual. Email is CROs’ primary method to exchange information with sites and sponsors, and most still use paper shipments and file shares.
CROs say the state of information exchange causes major challenges with tracking and reporting (71%), misfiled or missing documents (59%), and a host of other issues that limit collaboration and compliance.
As a result, CROs are initiating change to simplify information exchange with study partners, which they expect to yield significant benefits, including reduction in manual processes (77%), streamlined collaboration (65%), improved study quality (64%), and faster study execution (64%).
Study start-up is one of the most resource-intensive phases of clinical trials and has the most opportunity to drive greater efficiency and speed. All CROs report significant challenges with study start-up and more than three-quarters use spreadsheets to manage this area.
Site contracting and budgeting is the most cited and fastest growing issue during the study start-up process. The majority of CROs (70%) say it is their top challenge, up 11 percentage points since 2018. It is also among the primary drivers for change.
For most (80%), faster study start-up time is also a primary driver. Majorities say fewer spreadsheets and manual processes (60%), easier collaboration with sponsors and sites (55%), and better resource planning (55%) would also speed the study start-up process.
CROs are adopting more clinical technologies to eliminate manual processes and improve operational performance. The use of RTSM, eTMF, and CTMS systems has increased the most since 2017. In addition, more CROs are adopting purpose-built study start-up applications than sponsors to speed cycle times (35% of CROs vs. 23% of sponsors).
Replacing manual processes with technology for specific functions has created efficiencies, but it has also created silos. Integration (73%) and reporting across multiple applications (64%) are the top two challenges reported as a result of application silos.
CROs cite the need to streamline fragmented clinical processes and systems to improve study execution. All CROs say they need to unify clinical applications (100%). Better visibility and oversight (74%), faster trials (68%), and easier stakeholder collaboration (63%) are the top drivers to unify.
“CROs are leading the industrywide drive to improve execution and collaboration for faster clinical trials,” said Jim Reilly, vice president of Vault Clinical. “As more organizations reduce the manual and fragmented processes that are prevalent today, drug development will become much more streamlined and study partners will improve how they work together throughout the course of a trial.”
The Veeva 2019 Unified Clinical Operations Survey Report: Annual CRO Report examines CROs’ progress toward a unified clinical operating environment by gathering the experiences and opinions of CRO respondents from around the world. This annual research details the drivers, barriers, and benefits of a unified clinical operating model and tracks the industry’s progress toward unifying clinical systems and processes and aligning stakeholders throughout study execution. The full report is available online at veeva.com/CROreport