Modernizing clinical trial operations is a top priority among life sciences companies according to the Veeva 2020 Unified Clinical Operations Survey Report, one of the largest-ever global surveys of clinical operations professionals. Findings from Veeva Systems (NYSE: VEEV) reveal an industrywide drive to streamline processes for increased efficiency, quality, and speed in trials.
The shift to modernize has been well underway in major clinical areas such as eTMF, for example, where the number of respondents using eTMF has quadrupled since 2014 (68% vs. 17% in 2014). COVID-19 is now accelerating sponsor and CRO adoption of advanced applications to seamlessly manage trials and improve study performance. This research shows a significant opportunity to bring together clinical landscapes for faster execution, especially important as sponsors and CROs need to keep existing trials running and accelerate new trial starts.
Almost all sponsors and CROs report a need to unify their clinical applications, and most respondents (83%) now have initiatives planned or underway. The top drivers include better visibility and oversight, reduced manual processes, and improved study quality, underscoring the industry’s need to streamline end-to-end clinical processes and simplify information sharing for better trial performance.
Streamlining Collaboration and Information Exchange
Sponsors, CROs, and sites share a large amount of timely information that impacts trial outcomes. An over-reliance on manual methods, such as email and paper shipments, creates significant challenges with tracking and reporting, manual processes, and misfiled/missing documents.
All respondents report the need to simplify information exchange with study partners, signaling an urgency to find easier and more connected ways to collaborate. Reducing manual processes (75%), greater visibility and oversight (58%), and faster study execution (58%) are among the top drivers to improve information sharing during trials.
Advanced Clinical Applications Becoming the Norm
Many organizations have made progress in modernizing clinical processes and systems by adopting purpose-built applications. eClinical solutions such as EDC (91%), eTMF (78%), and CTMS (64%), are utilized by most sponsors and CROs, as function-specific technologies to support clinical trials become the industry standard.
Those using advanced clinical applications are reporting significant benefits. Sponsors and CROs using purpose-built CTMS applications see considerable improvements in compliance with standards, governance and oversight, and study performance metrics and reporting. CTMS applications are the most effective tool for managing end-to-end clinical trial processes compared with homegrown systems and manual spreadsheets.
Consistent with the industry’s effort to streamline information sharing, more than one-third of respondents say faster collection of site essential documents and easier collaboration will improve study start-up. Manual processes like email and paper shipments to exchange trial documents with sites cause delays. Automating areas like contracts and budgets and site essential document collection are key to accelerating trials.
“Life sciences companies recognize the significant opportunity to improve how trials are run and are modernizing their clinical operations,” said Jim Reilly, vice president, Vault R&D at Veeva Systems. “COVID-19 is accelerating the transition to more connected ways of working that will have a long-term positive impact on the efficiency and speed of drug development.”
The Veeva 2020 Unified Clinical Operations Survey Report examines the life sciences industry’s progress toward modernizing clinical operations by gathering the experiences and opinions of more than 500 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 trial systems and processes, and increase stakeholder engagement throughout study execution. The full report is available online at veeva.com/eu/ClinicalSurvey.