CROs leading industrywide drive to improve the efficiency and speed
of clinical trials
BOSTON--(BUSINESS WIRE)--
Outsourcing in Clinical Trials New England – Veeva
Systems (NYSE:VEEV) today unveiled the results of the Veeva
2016 Paperless TMF Survey: CRO Report. The global industry
survey of trial master file (TMF) owners shows growing use of electronic
trial master file (eTMF) solutions among clinical research organizations
(CROs) as a result of benefits in audit and inspection readiness. In
addition, findings reveal that CROs are leading the drive toward active
TMF management and making strides in the use of performance metrics and
data to improve the efficiency and speed of clinical trials.
eTMF Solutions Significantly Improve Inspection Readiness
eTMFs are helping CROs to maintain complete and accessible trial master
files to reduce the number of inspection findings. CROs who use eTMF
applications are achieving significant improvements across major
inspection finding categories such as fewer duplicate documents (61%),
misfiled documents (53%), and incomplete documents (51%).
Given these benefits, one of the top drivers of eTMF adoption among a
majority of CROs (65%) is improved audit and inspection readiness. At
the same time, CROs are now less reliant on document exchange methods
that are more difficult to track and provide little to no audit trail.
For example, the use of email for document exchange is down
significantly from 80% in 2014 to 61% today, while almost a third (31%)
are using an eTMF application to share TMF documents with sponsors (up
from 24% in 2014).
CROs Leading Transition to Active TMF Management
With a focus on improving inspection readiness, CROs are shifting to an
active TMF management approach, a trend that has increased since the
first Veeva Paperless TMF Survey in 2014. In active TMF
management, purpose-built eTMF applications manage documents and
processes in real-time as the TMF is being generated and provide global
access for stakeholders. Conversely, in passive TMF management, TMF
documents are simply stored and archived in file systems and other
static repositories at the end of a trial rather than as part of the
trial workflow.
Nearly one-third of CROs (30%) now use purpose-built eTMF applications
that enable active TMF management, up from 21% in 2014. At the same
time, there was a significant drop in the use of passive eTMF systems,
including cloud file shares (9% in 2016 vs. 21% in 2014) and local file
systems (16% in 2016 vs. 26% in 2014). In addition, CROs have
significantly reduced the amount of TMF documents managed on paper, with
less than a quarter (22%) reporting that most to all TMF documents are
managed on paper (down from 47% in 2014).
eTMFs Provide Better Visibility into TMF Performance
Another key driver of eTMF adoption among a majority of CROs (57%) is
improved visibility into performance metrics. CROs are not only
capturing metrics but also making large strides in putting the data to
use, with a quarter of CROs (24%) now extensively using TMF data to
improve trial processes (up from 16% in 2015) and another 46% leveraging
data in some cases (up from 40% in 2015).
In terms of other key benefits of eTMF adoption, 44% of CROs find that
they have better visibility into performance metrics. In addition, a
majority of CROs have achieved significant improvements in central and
remote auditing (56%) and automated tracking and reporting of documents
(56%), both of which are key in providing timely and accurate status
updates to sponsors.
“Over the past several years CROs have played a pivotal role in moving
the life sciences industry toward more efficient clinical trial
processes,” said Jill Johnston, vice president of Veeva Vault Clinical.
“As clinical trials become increasingly outsourced, we’ll see that trend
continue especially as demand grows for unifying systems, processes, and
stakeholders across clinical operations.”
To hear the full results of the Veeva 2016 Paperless TMF Survey: CRO
Report, see Veeva’s presentation at the Outsourcing in Clinical
Trials New England conference on September 7 at 3:15 p.m. Conference
attendees can also visit Veeva booth #7 for a copy or download
it here.
Survey Methods
The Veeva 2016 Paperless TMF Survey: CRO Report 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.
Additional Information
For more on Veeva Vault eTMF, please visit: veeva.com/etmf
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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 450 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 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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Source: Veeva Systems Inc.