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New Survey Finds Fragmented Processes and System Silos Slowing Clinical Trials


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 Survey examines 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 Survey will be presented at the DIA 2019 Annual Meeting on June 24 at 1:00 p.m. in Innovation Theater 1 in the exhibit hall. The full report is available online at veeva.com/ClinicalSurvey.

Additional Information

Connect with Veeva on LinkedIn: linkedin.com/company/veeva-systems

Follow @veevasystems on Twitter: twitter.com/veevasystems

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About Veeva Systems

Veeva Systems Inc. is the leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 750 customers, ranging from the world's largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices throughout North America, Europe, Asia, and Latin America. For more information, visit veeva.com.

Forward-looking Statements

This release contains forward-looking statements, including the market demand for and acceptance of Veeva's products and services, the results from use of Veeva's products and services, and general business conditions, particularly in the life sciences industry. Any forward-looking statements contained in this press release are based upon Veeva's historical performance and its current plans, estimates, and expectations, and are not a representation that such plans, estimates, or expectations will be achieved. These forward-looking statements represent Veeva's expectations as of the date of this press announcement. Subsequent events may cause these expectations to change, and Veeva disclaims any obligation to update the forward-looking statements in the future. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially. Additional risks and uncertainties that could affect Veeva's financial results are included under the captions, "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations," in the company's filing on Form 10-Q for the period ended April 30, 2019. This is available on the company's website at veeva.com under the Investors section and on the SEC's website at sec.gov. Further information on potential risks that could affect actual results will be included in other filings Veeva makes with the SEC from time to time.

Research Highlights

Veeva 2019 Unified Clinical Operations Survey

The Veeva 2019 Unified Clinical Operations Survey examines 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.

Unifying Clinical Processes for Better Visibility and Collaboration

Improving Information Exchange Among Partners a Priority

Accelerating Study Start-up to Speed Execution

Streamlining TMF Processes and Trial Management to Improve Performance


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