eTMF application use doubles amid industry-wide drive to improve
inspection readiness and shorten clinical trial time
PHILADELPHIA--(BUSINESS WIRE)--
DIA 2016 Annual Meeting - Today, at the Drug Information
Association’s (DIA) Annual Meeting, Veeva Systems (NYSE:VEEV) reported
the latest findings of the industry’s largest, annual global survey of
trial master file (TMF) owners, the Veeva
2016 Paperless TMF Survey. The new research study reveals
significant change is underway as the industry shifts from passive to
active TMF management and adopts advanced electronic TMF (eTMF)
applications to improve inspection readiness and shorten clinical trials.
Transition from passive to active TMF management accelerates
Maturity of TMF processes varies widely from passive TMF management –
where TMF documents are simply stored and archived in file systems and
other static repositories – to more advanced active TMF management –
where purpose-built eTMF applications manage documents and processes in
real-time as the TMF is being generated. Documents are created,
reviewed, and acted upon in one system that is accessed by all study
partners.
Since the first Paperless TMF Survey in 2014, there has been a major
shift from passive to active TMFs, as sponsors’ adoption of advanced
eTMF applications has increased nearly twofold to 24%. Sponsors using
local file systems as their eTMF dropped from 26% in 2014 to just 8%
today. During the same period, clinical operations departments cut the
use of paper for most or all TMF documents from 41% to 28%.
Sponsors move to unify systems, processes, and stakeholders
As life sciences companies move to more active TMFs, there is not only a
marked reduction in paper and manual process in favor of electronic
means to manage the TMF, but the use of centralized systems to
collaborate with trial partners is also on the rise.
One in four (23%) sponsors now use their eTMF application to share
documents with CROs, up from 14% in 2014. Similarly, more sponsors use
eTMF applications to exchange documents with sites (16%, up from 11% in
2014). On the heels of the MHRA’s mandate for TMF accessibility1,
the majority (80%) of sponsors using an eTMF application now provide
remote access to inspectors and auditors or plan to do so within the
next year.
The clinical operations landscape remains highly fragmented with
duplicate content and data in multiple systems across different
functional areas and partners. Clinical leaders want full visibility and
greater control, prompting rapid change toward unifying clinical
operations for one process, one system, and one view. This is
underscored by the growing demand to integrate eTMF applications with
other clinical systems. Half (49%) of sponsors cite integration of their
eTMF application with their clinical trial management system (CTMS) as a
key need.
TMFs growing role in advancing clinical operations goals
Improving inspection-readiness and speeding study startup are the two
most cited business benefits driving eTMF adoption among sponsors (67%
and 53% respectively). Remote oversight of the TMF (48%) and better
visibility into performance metrics (40%) also rate high as motivators
for eTMF adoption.
The data show the drivers prompting eTMF adoption are indeed the
benefits realized by those using purpose-built eTMF applications. eTMF
application users report significant improvements in several areas,
including inspection readiness (61%), improved central and remote
monitoring (59%), and better visibility into performance metrics (55%).
Users of other types of eTMFs such as local or cloud file shares are
significantly less likely to see these benefits.
When asked about the specific benefits in key inspection areas, nearly
all (98%) respondents with an eTMF application saw major improvements in
at least one area, including duplicate, missing, or incomplete documents.
In addition, organizations that extensively use metrics to improve trial
processes see more benefits than those who do not, such as improved
audit and inspection readiness (67% vs. 29%), better visibility into
performance metrics (53% vs. 14%), and cost savings (47% vs. 10%).
Metrics also play an important part in speeding time to market.
Respondents using an eTMF and extensively using metrics experienced
faster study startup and shortened clinical time as compared to those
not collecting data (20% vs. 5% and 23% vs. 5%, respectively).
“eTMF applications are becoming an integral component of clinical
operations as sponsors mature their TMF processes,” said Jennifer
Goldsmith, senior vice president of Veeva Vault. “As the industry pushes
toward unifying systems, processes, and stakeholders across clinical
operations, the speed of clinical trial execution will continue to
accelerate.”
In
related news last week, Veeva introduced the industry’s first true
multitenant cloud solution for clinical trial management, Veeva Vault
CTMS, to unify information, documentation, and processes across clinical
operations globally. Together with Veeva Vault eTMF, Veeva will offer
the first and only suite of clinical applications that combines CTMS and
eTMF on one cloud platform to accelerate trial execution and gain
real-time visibility into clinical operations.
Survey Methods
The survey consisted of 13 questions, many of which included
sub-questions with response matrices. Survey questions were designed for
individuals with knowledge of TMF document processes and with partial or
full responsibility for a TMF within their organization. The survey was
commissioned by Veeva Systems and conducted by Fierce Markets.
Completion of the survey was voluntary, and a $5 donation was made to
Doctors Without Borders for each valid completion of the full survey.
All respondents were offered a summary of the survey results. No other
compensation was offered or provided.
The full results of the Veeva 2016 Paperless TMF Survey will be
presented at the DIA 2016 Annual Meeting on Tuesday, June 28 at 3:25pm
in the Innovation Theater, Exhibit Hall B. DIA attendees can also visit
Veeva’s booth, #1308 for a copy of the executive summary. The report is
also available online at veeva.com/TMFSurvey2016.
Additional Information
For more on Veeva 2016 Paperless TMF Survey, visit: veeva.com/TMFSurvey2016
For more on the Veeva suite of clinical products, visit: veeva.com/clinical
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About Veeva Systems
Veeva Systems Inc. is a leader in cloud-based software for the global
life sciences industry. Committed to innovation, product excellence, and
customer success, Veeva has more than 400 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 www.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, 2016. 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.
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1 United Kingdom Medicines and Healthcare products Regulatory
Agency. Good Clinical Practice for Clinical Trials. December 18,
2014.
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Source: Veeva Systems