Sponsors en CRO’s versnellen de overgang om systemen en processen te verenigen

COVID-19, waardoor het dringend nodig is om bestaande onderzoeken op schema te houden en nieuwe onderzoeken te versnellen

BARCELONA, Spanje – (BUSINESS WIRE) – Het moderniseren van klinische proefactiviteiten is een topprioriteit onder biowetenschappelijke bedrijven volgens het Veeva 2020 Unified Clinical Operations Survey Report, een van de grootste wereldwijde enquêtes ooit onder professionals in klinische operaties. Bevindingen van Veeva Systems (NYSE: VEEV) onthullen een industriebrede drive om processen te stroomlijnen voor meer efficiëntie, kwaliteit en snelheid in proeven.

De verschuiving naar modernisering is in volle gang op belangrijke klinische gebieden zoals eTMF, waar het aantal respondenten dat eTMF gebruikt sinds 2014 verviervoudigd is (68% versus 17% in 2014). COVID-19 versnelt nu de acceptatie door sponsors en CRO van geavanceerde applicaties om proeven naadloos te beheren en de studieprestaties te verbeteren. Dit onderzoek toont een aanzienlijke kans om klinische landschappen samen te brengen voor snellere uitvoering, vooral belangrijk omdat sponsors en CRO’s bestaande onderzoeken moeten laten draaien en het starten van nieuwe onderzoeken moeten versnellen.

Global Survey Shows Industrywide Priority to Modernize Clinical Trials for Faster Study Execution

Sponsors and CROs accelerate move to unify systems and processes

COVID-19 prompting urgent need to keep existing trials on track and speed new studies

BARCELONA, Spain–(BUSINESS WIRE)– 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/ClinicalSurvey.

About Veeva Systems

Veeva Systems Inc. is a leader in cloud solutions—including data, software, and services—for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 900 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. The company is headquartered in the San Francisco Bay Area, with offices throughout North America, Europe, Asia, and Latin America. For more information, visit veeva.com/eu.

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 (including the on-going impact of COVID-19), particularly within 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 July 31, 2020. 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 2020 Unified Clinical Operations Survey Report

The 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 globally. The 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.

Modernizing Clinical Operations to Speed Study Execution

• Most sponsors and CROs now utilize standalone, eClinical applications as they steadily adopt function-specific technologies to support clinical trials including, EDC (91%), eTMF (78%), and CTMS (64%).
• Nearly all (98%) respondents say they have significant challenges with their clinical applications. The top three challenges – integrating multiple applications (70%), managing trial information across applications (57%), and reporting across multiple applications (56%) – are likely the result of system and process silos.
• Most (98%) report the need to unify clinical applications, and 83% say their organizations now have initiatives planned or underway.
• The need to unify clinical application landscapes is driven by better visibility and oversight (70%), reduced manual processes (69%), improved study quality (60%), faster study execution (56%), and improved collaboration (52%).

Improving the Flow of Information in Trials for Better Collaboration

• All (100%) respondents say they need to improve information sharing between study partners to reduce manual processes (75%), improve visibility and oversight (58%), and speed trials (58%).
• Email is the predominant way sponsors and CROs exchange information with sites (78%), followed by paper shipments (40%), and portals (38%).
• Nearly all (99%) report significant challenges with the methods used to exchange information during clinical trials.
• Managing information exchange via email and other traditional methods contribute to issues respondents have with tracking and reporting (67%), manual processes (64%), and misfiled/missing documents (53%).

Streamlining Study Start-up to Accelerate Cycle Times

• All (100%) respondents say they need to improve study start-up processes.
• More than one-third say faster collection of site essential documents (44%) and easier collaboration (42%) will improve study start-up, highlighting the importance of streamlined information sharing and collaboration to trial performance.
• Majorities (81%) use spreadsheets to manage study start-up processes. Roughly half use eTMF (52%) and CTMS (50%) applications.

Digitizing Trial Processes for Higher Quality Results

• The number of respondents using an eTMF application has quadrupled since 2014 (68% vs. 17% in 2014). The growth in eTMF adoption comes as organizations increasingly move away from general-purpose methods to manage TMF processes.
• Sponsors and CROS using advanced CTMS applications to manage clinical studies report significant advantages over manual processes and other systems, including compliance with standards (58% versus 37%, respectively), governance and oversight (48% versus 38%, respectively), and study performance metrics and reporting (46% versus 32%, respectively).

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Contacts

Roger Villareal

Veeva Systems

925-264-8885

roger.villareal@veeva.com

Deivis Mercado

Veeva Systems

925-226-8821

deivis.mercado@veeva.com