New Survey Finds Fragmented Processes and System Silos Slowing Clinical Trials

Sponsors and CROs accelerate move to modernize and speed study
execution

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

Additional Information

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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

• 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.

Contacts

Roger Villareal
Veeva Systems
925-264-8885
[email protected]

Kiran May
Veeva Systems
+44-796-643-2912
[email protected]