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CHICAGO - DIA 2017 Annual Meeting - June 19, 2017 - There is an industrywide drive toward a unified clinical operating model, according to the Veeva 2017 Unified Clinical Operations Survey, one of the industry’s annual surveys of clinical operations professionals. The latest findings from Veeva Systems reveal that nearly all respondents (99%) cite the need to unify applications, including CTMS, EDC, and eTMF, across clinical operations. Faster study execution (65%) and improved study quality (63%) are the top drivers for a unified clinical model, which is characterized by end-to-end processes and systems, collaboration among stakeholders, and greater insights across the clinical lifecycle to improve study performance.
Streamlining Clinical Systems and Processes
Life sciences organizations recognize the need to create end-to-end operational processes for greater efficiency and effectiveness across the clinical ecosystem. But, nearly all survey respondents (99%) report at least one major challenge with their clinical applications, most often stemming from application and process silos where 69% cite integrating multiple applications as their biggest issue. Most say (76%) unifying their applications will drive improvements in three or more important areas, including study speed and quality.
In CTMS, half (49%) of sponsors say the challenge of integrating their eTMF or EDC applications with CTMS limits their organization’s ability to improve clinical operations. In the case of study start-up, the greater the number of applications used, the greater the number of challenges reported. Three-fourths of sponsors using two or more applications more frequently experience issues with site contracting and budgeting (60%), site identification (49%), and study planning during protocol design (40%).
Simplifying Internal and External Collaboration
Easier collaboration (52%) among global stakeholders is a top driver to unify clinical applications. One out of three sponsors (33%) report that the limited ability to collaborate with external partners is one of the biggest challenges with their current clinical applications. One area that is reliant on collaboration is study start-up, where 95% of sponsors report challenges.
Regarding Trial Master Files (TMFs), sponsors are moving away from manual systems and relying less on paper in an effort to streamline collaboration. One in three (31%) now use an eTMF application (up from 13% in 2014) and only 16% of sponsors say their clinical operations departments use paper for most or all TMF documents, down significantly from 41% in 2014. Consistent with the drive to streamline collaboration, the number of TMF documents managed on paper is down by at least half among sponsor companies since 2014 across almost all functional areas measured.
Modern, cloud-based eTMF applications have a direct impact on improving collaboration. When asked what benefits were achieved after implementing an eTMF application, almost half (45%) of sponsors report easier collaboration with partners.
Improving Visibility Into End-to-End Processes
A major challenge many organizations (61%) face is reporting across multiple applications, which limits visibility into data and insights across clinical operations. Half of respondents (51%) cite better study visibility as one of the most important drivers for unifying clinical. In addition to data across many systems, 30% say that tracking data outside their clinical systems is a major issue as a result of users working around established clinical processes, which creates further visibility challenges.
On the other hand, organizations that extensively use data to improve clinical trial processes see more benefits than those not leveraging data, including easier collaboration (50% to 25%, respectively), central and remote auditing (50% to 31%, respectively), and automated tracking and reporting of documents (54% to 38%, respectively).
“The industry’s progress toward a unified clinical environment is being driven by the need to address the growing complexity in clinical trials,” said Jennifer Goldsmith, senior vice president of Veeva Vault. “Life sciences companies are taking steps to streamline their end-to-end processes and systems to execute faster, improve quality, and simplify collaboration across their study portfolios.”
The Veeva 2017 Unified Clinical Operations Survey examines the life sciences industry’s progress toward a unified clinical environment by gathering the experiences and opinions of 300 clinical operations professionals from around the globe. Evolved from the annual Veeva Paperless TMF Survey, this research examines the drivers, barriers, and benefits of a unified clinical operating model and tracks the move to streamline clinical systems and processes.
The full results of the Veeva 2017 Unified Clinical Operations Survey will be presented at the DIA 2017 Annual Meeting on June 20 at 9:45 a.m. in Innovation Theater #1 in the Exhibit Hall. The report is also available online atveeva.com/ClinicalSurvey.
For more on Veeva 2017 Unified Clinical Operations Survey, visit: veeva.com/ClinicalSurvey
For more on Veeva Vault Clinical Suite, visit: veeva.com/Clinical
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About Veeva Systems
Veeva Systems Inc. creates cloud-based software for the global life sciences industry. Veeva has more than 525 customers, ranging from the world's largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices in Europe, Asia, and Latin America. For more information, visit veeva.com.