Industry-wide survey shows eTMF applications improve inspection
readiness and seen as key to shortening development time
WASHINGTON--(BUSINESS WIRE)--
New research shows life sciences organizations are increasing their use
of advanced electronic trial master file (eTMF) applications and
clinical operations departments are moving away from paper processes in
managing their trial master file (TMF). Some business processes have
been slower to make the move from paper, but TMF owners say barriers to
conversion are low and increased use of electronic processes could speed
time to market.
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These are some of the findings of the Veeva
2015 Paperless TMF Survey: Annual Report, released today at the
Drug Information Association’s (DIA) Annual Meeting. The global study of
TMF owners found a striking reduction in paper used by clinical
operations since 2014. Today, 31% of respondents are managing “most or
all” TMF documents on paper, down 12 percentage points from 43% last
year.
One in four respondents now report using eTMF applications to exchange
TMF documents between sponsors and CROs, up nine percentage points from
2014. With the use of more advanced technology, trial sponsors and
contract research organizations (CROs) are now relying considerably less
on paper shipments and fax to exchange documents with sponsors, both
down 10 percentage points in just one year.
“ClinOps is responsible for more than half of all documents in the TMF;
therefore, their move off of paper is vital,” said Jennifer Goldsmith,
vice president of Veeva Vault at Veeva Systems. “After moving to an
electronic format, the next phase is implementing electronic processes.
Not surprisingly, the first advances are in sponsor-CRO collaboration,
which has been a significant pain point for many companies. When we look
at the transformation in sponsor-CRO document exchange, we see
significant, measurable progress.”
However, there is considerable variation in the adoption of eTMF
processes. Less than one third of respondents are “mostly or always”
using electronic methods for e-signature of documents (21%), electronic
creation of source documents (25%), and electronic collaboration with
external partners (30%).
The majority of respondents see benefits to shifting additional
activities to electronic processes. For instance, 63% of those surveyed
said they believe managing TMF filing in an eTMF would shorten
development time, while 57% believe managing study/site start-up in an
eTMF would shorten development time.
Given the growing expectations from health authorities like the
Medicines and Healthcare Products Regulatory Agency (MHRA) around
inspection readiness and TMF accessibility, the survey provides some
positive indicators. Half of all eTMF users (49%) and 61% of those using
eTMF applications cited improvements in inspection readiness due to
using an eTMF. Users of eTMF applications are also more than twice as
likely (57%) to grant auditors and inspectors remote access to the TMF
than respondents as a whole (26%). Two-thirds (65%) of all respondents
expect to grant remote access within the next two years.
The survey found only a small number of organizations (14%) are
extensively using TMF data to improve trial processes. But as an
increasing number of clinical documents are managed electronically, the
use of metrics to improve study processes is expected to rise.
Organizations that use eTMF applications or content management systems
are more than twice as likely to extensively use metrics than those
using less advanced cloud file share and local file systems.
“Despite reports that eTMF metrics lead to critical study process
improvements, Veeva’s 2015 study reveals that most companies are still
not actively using metrics,” said Linda Sullivan, chief operating
officer of Metrics Champion Consortium, an association dedicated to
standardized performance metrics. “As more data is collected over time
and across multiple trials, it will be possible to identify important
trends about study performance. The eTMF can inform business decisions
by capturing an array of quality, performance, and operational metrics,
internally and externally, across multiple sites and studies.”
The full results of the Veeva 2015 Paperless TMF Survey: Annual
Benchmark will be presented at the DIA Annual Meeting on Tuesday,
June 16 at 1 p.m. EDT in the Innovation Theater. DIA attendees can also
visit Veeva’s booth, #1203, for a copy of the executive summary. The
report is also available online at veeva.com/2015tmfsurvey.
Additional Information:
About Veeva Vault
Veeva Vault is the first cloud-based regulated content management
platform and suite of applications designed for life sciences. It spans
clinical, quality, commercial, medical, and every major part of a global
life sciences company to ensure one trusted source for content and data
across the enterprise. Helping companies connect securely in the life
sciences cloud, Vault provides complete control from start to finish, as
well as the easy accessibility, visibility, and agility needed to speed
time to market. All Vault applications offer real-time reporting and
dashboards; an intuitive, consumer-web interface; and a true multitenant
cloud architecture that continuously delivers rapid innovation. Today,
more than 135 customers rely upon Vault to manage critical content and
the number of Vaults has grown threefold in just one year.
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 275 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, 2015. This is available on the
company’s website at www.veeva.com
under the Investors section and on the SEC’s website at www.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.