Business Wire

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

Additional Information

Connect with Veeva on LinkedIn:
Follow @veeva_eu on Twitter:
Like Veeva on Facebook:

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

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 under the Investors section and on the SEC’s website at 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

  • Standalone, eClinical applications, including EDC (88%), eTMF (69%), and CTMS (61%) are now utilized by most companies as sponsors and CROs steadily adopt function-specific technologies to run clinical trials.
  • Nearly all (97%) respondents say they have at least one major challenge with their clinical applications, and more than three-quarters (83%) have two or more challenges.
  • The top two issues – integrating multiple applications (68%) and reporting across multiple applications (57%) – are the direct result of clinical application silos.
  • Nearly all respondents (99%) say they need to unify their clinical trial systems and processes. Main drivers include better visibility (70%), faster study execution (63%), easier collaboration (61%), and improved study quality (56%).

Improving Information Exchange Among Partners a Priority

  • All respondents (100%) report the need to simplify information exchange in clinical trials between sponsors, CROs, and sites. The primary drivers are reducing manual processes (71%), improving collaboration (66%), and increasing visibility and oversight (64%).
  • On average, sponsors and CROs use three methods for information exchange, and one-quarter (25%) use at least four methods. Email is the predominant way sponsors exchange information with CROs (78%), followed by portals (51%), file share (51%), and eTMF applications (38%).
  • The majority (96%) of respondents say they have significant challenges with the methods used to exchange information during clinical trials. Tracking and reporting (71%), misfiled or missing documents (56%), and manual document exchange (47%) are the biggest challenges with information exchange.

Accelerating Study Start-up to Speed Execution

  • All respondents (100%) report challenges with the study start-up process. Almost three-quarters (73%) say site contracting and budgeting is one of the most challenging study start-up processes, followed by site identification and selection (49%) and IRB/ethics committee approval and planning (42%).
  • More than half of respondents cite faster study start-up times (71%), streamlined site contracting and budgeting (60%), and better site feasibility and selection outcomes (52%) as primary drivers to improve study start-up processes. Half of survey respondents (50%) say easier collaboration between sponsors, CROs, and sites is essential to improve study start-up.
  • Most (81%) use spreadsheets to manage study start-up, followed by CTMS (38%), eTMF (35%), internally developed applications (29%), and online survey tools (25%). Nearly one-quarter (23%) now have adopted newer, purpose-built study start-up applications.

Streamlining TMF Processes and Trial Management to Improve Performance

  • The number of sponsors and CROs using an eTMF application has tripled since 2014. More than half (56%) now use a purpose-built eTMF application, versus 17% in 2014.
  • The increase in the use of eTMF applications is matched by a sharp decline in the use of content management systems, signaling a shift away from general-purpose methods where TMFs act as static repositories, to modern purpose eTMF application that enable more ‘active’ trial management. Today, only 8% use content management systems for TMF management, versus 31% in 2017.
  • Those using active purpose-built applications report a significant positive impact on inspection-readiness (60%), increased visibility into TMF status (58%), and centralized auditing (36%). They also report fewer challenges complying with standards (8% for purpose-built TMF users versus 31% using other methods) and TMF tracking and reporting (47% versus 64%, respectively).
  • Nearly all sponsors and CROs surveyed (90%) say they have at least one major challenge with their CTMS applications, and three-quarters (74%) report two or more challenges. Integrating CTMS applications with other clinical systems (63%) and study performance metrics and reporting (53%) are the most frequently cited challenges.
  • One-third say challenges with CTMS applications limit efficiency across key clinical trial management processes, including monitoring (38%), resource management (36%), and issue and task management (31%).
  • Nearly all (95%) report the need to improve the use of CTMS in clinical operations. A majority cite better analytics and reporting (68%), increased visibility (60%), and proactive risk identification and mitigation (58%) among the primary reasons to improve CTMS. Almost half of sponsors and CROs (48%) say easier internal and external collaboration is a top driver to improve clinical operations.

Contact information

Roger Villareal
Veeva Systems

Kiran May
Veeva Systems

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

New Spanish OTT Provider Plataforma Multimedia de Operadores Selects Verimatrix for Optimal Video Streaming Security21.11.2019 16:40:00 CETPress release

Regulatory News: Verimatrix, (Paris:VMX), a global provider of security and business intelligence solutions that protect content, devices, applications and communications, today announced that Plataforma Multimedia de Operadores has joined a long list of customers that trust Verimatrix Multi-DRM. The Spanish OTT video provider selected the solution to provide a complete multi-screen security solution for its brand-new OTT service. Plataforma Multimedia de Operadores is a new company created by the main players of the historical cable industry in Spain offering a purely OTT-based TV platform delivered via Android set-top boxes, smartphones, tablets, laptops and smart TVs. Supported by Verimatrix partners Mirada and Anevia, the platform delivers content with a cutting-edge viewing experience and offers unique tools for content discovery, personal recommendations, session transfer, cloud DVR and much more. “We developed our platform to provide Spanish audiences with a flexible, reliable,

Optiv and Veracode to Bolster Application Security at Development Stage with Software Assurance as-a-Service21.11.2019 16:05:00 CETPress release

Optiv Security, a security solutions integrator delivering end-to-end cybersecurity solutions, today announced it has partnered with Veracode to improve application security at the development level. The new Software Assurance as-a-Service (SAaaS) offering leverages Optiv’s industry-leading cybersecurity knowledge and Veracode’s robust program management framework and software testing automation technology to help organizations secure web applications without slowing down the speed of development. “Considering that the majority of web applications are released without being tested for security, our new foundational application security program, in partnership with Veracode, gives organizations confidence to release secure software while reducing risk, time to market and reactive costs,” said Bryan Wiese, division vice president, advisory services for Optiv. “As a security solutions integrator, Optiv is uniquely positioned to help organizations’ plan, build and run any element of their

Enconnex Acquires Active Energy Solutions Division of Methode Electronics, Inc.21.11.2019 16:00:00 CETPress release

Enconnex announced today that it has acquired assets of Active Energy Solutions (AES), a division of Methode Electronics, Inc., solidifying the long-term relationship between the two firms. Under an exclusive distribution agreement with AES, Enconnex has been offering the AC6000 uninterruptible power supply (UPS) to its customers. Enconnex has established a new manufacturing facility in its Reno, Nev., headquarters and incorporated the product into its integrated data center solutions. This press release features multimedia. View the full release here: Strategic Acquisition Solidifies Long-Term Relationship and Enables Efficient Manufacture and Delivery of Innovative Lithium-Ion UPS. (Graphic: Business Wire) “This acquisition is the logical extension of our strategic partnership with AES,” said Thane Moore, Director of Product Line Management, Enconnex. “The AC6000 is a robust yet eco-friendly UPS that offers the advanced featur

Arch Re to Acquire Global Credit & Surety Renewal Rights From Aspen Re21.11.2019 15:51:00 CETPress release

Arch Reinsurance (Arch Re), a wholly owned subsidiary of Arch Capital Group Ltd. (ACGL), and Aspen Reinsurance (Aspen Re), the reinsurance business segment of Aspen Insurance Holdings Limited (Aspen), jointly announced that Arch Re has entered into a renewal rights agreement with Aspen Re on its global credit and surety reinsurance business after Aspen Re’s decision to exit the line. In addition to the renewal rights on the portfolio, the parties have agreed to initiate additional discussions about the potential novation of the existing book in the coming months. Arch has extended employment offers to all of Aspen Re’s Zurich-based credit and surety employees to join Arch Re’s existing credit and surety team based in Zurich. “This is a unique opportunity for us to not only augment and diversify our credit and surety portfolio through the acquisition of Aspen Re’s renewal rights, but to also add talented employees to our team,” said Michael Hammer, President and CEO of Arch Re Europe. “

Daisy Wins AI Company of the Year at the Canadian FinTech & AI Awards21.11.2019 15:50:00 CETPress release

Daisy Intelligence was named AI Company of the Year at the prestigious Canadian FinTech & AI Awards. Daisy provides AI-powered solutions for the insurance and retail industries that deliver dramatically improved business results. “With Canada regarded as one of the global leaders in artificial intelligence, this award is a major accomplishment for Daisy,” said Gary Saarenvirta, founder and CEO of Daisy. “It reflects the growing recognition of our unique technology, and it is a step towards our vision of becoming the world’s largest and most respected AI company.” The Canadian FinTech & AI Awards recognize and celebrate Canadian innovation in financial technology and artificial intelligence. The awards were presented at the 5th Annual Canadian FinTech & AI Awards gala hosted by the Digital Finance Institute, a think tank that covers the nexus between FinTech, financial innovation, AI, financial regulation, and financial inclusion. “Daisy has established itself as one of the very few com

New CloudBlue Connect Delivers Omni-Product Platform that Unifies Multiple Channels21.11.2019 15:12:00 CETPress release

CloudBlue, an Ingram Micro business, today announced the global launch of CloudBlue ConnectTM, an omni-product platform aimed at helping vendors and service providers expand their reach and decrease time to market with minimal overhead costs. The CloudBlue Connect platform is capable of helping a company use only one system to manage its go-to-market channels – direct and indirect – supporting both traditional and recurring digital products and services. Furthermore, the platform automates many of the time-intensive tasks of managing a go-to-market channel, including contract management, maintaining product information, fulfillment, usage management and subscription services. “Vendors and service providers have long been struggling to manage multiple integrations for their partnership and channel programs and have been forced to invest a huge amount of resources in development and maintenance,” said Tarik Faouzi, vice president of CloudBlue. “CloudBlue Connect alleviates these issues,