|By Business Wire
|August 20, 2014 07:03 AM EDT
Improving audit readiness is one of the top goals for life sciences
companies implementing a new electronic TMF solution today, and Pharma
Start is no exception. Since adopting Veeva Systems’ cloud-based Vault
eTMF solution, the contract research organization (CRO) is now prepared
for inspection at all times and has the visibility needed to establish
collaborative relationships with sponsors. Vault eTMF enables real-time
information sharing in the cloud between Pharma Start teams, clinical
partners, and its 75+ investigator sites around the globe. Additionally,
Vault eTMF supports Pharma Start’s steadfast commitment to minimize its
carbon footprint by eliminating the environmental impact of shipping
paper, especially important in clinical work, where a single study can
yield 5,000+ reams of paper a year, equal to 295 or more trees.
“We wanted to find a way to eliminate paper and improve process
efficiency while complying with global requirements for a trial master
file and adhering to our footprint goal,” explained Tom McGrady, Pharma
Start’s vice president of quality assurance. The company turned to Vault
eTMF for its flexible cloud architecture, ease of use, and ability to
comply with 21 CFR Part 11. Plus, with TMF documents always up to date
in Vault’s centrally accessible system, Pharma Start is better prepared
for audit at all times. “We had a lot of criteria but Vault eTMF met all
of them,” said McGrady.
Pharma Start initially considered other eTMF applications, but a cloud
solution proved critical in order to remain true to its environmental
goal. An in-depth study conducted by Accenture and Microsoft determined
that the average 100-person company can reduce energy consumption and
emissions by more than 90 percent by deploying all business applications
in the cloud.1 Multitenant cloud applications, specifically,
have proven to be greener alternatives to traditional systems, as they
serve many customers that would otherwise each utilize their own
resources to power, cool, and maintain the required infrastructure.
Further, Veeva’s data centers use advanced technologies to optimize
temperature control and reduce energy consumption.
“Securely accessible in the cloud and as easy to use as Amazon, Vault
eTMF ensures both external and internal teams can fully leverage the
system. Everyone can work in parallel so we don’t wait, for example,
while physical documents are shipped to sites or a wet signature is
captured via courier from locations all around the globe,” explained
Rebecca Moraris, Pharma Start’s director of clinical operations. “Vault
eTMF also provides total transparency and a better vantage point for
sponsors, sites, and internal groups to identify problems early and fix
Since implementing Vault eTMF, Pharma Start has experienced major
efficiency gains. “It really comes down to improved productivity,” added
Moraris. “With Vault eTMF, processes and workflows can be automated so
individual sites don’t have to recreate the wheel but simply pull down a
template, complete it, and upload it back into Vault for all to see in
real time. Placement into the eTMF happens automatically.”
Moraris continued, “We see tremendous hidden cost savings because TMF
documents are uploaded, QC’d, and approved in the system all along the
way. For study start-up, there’s less chasing documents and signatures,
and at study close-out, we’ll eliminate the painful document
Vault eTMF is part of Veeva’s Development Suite, a cloud-based line of
integrated content management applications for the life sciences
industry. Supporting the R&D process from clinical trials to quality and
regulatory submissions, the Veeva Development Suite provides
pharmaceutical, biotechnology, and medical-device companies the ability
to deploy a single content management system globally.
Pharma Start has joined the many life sciences organizations making the
switch from paper to an electronic TMF and is working through the common
challenges associated with change. “People always fear change, primarily
because they worry about a loss of control. We’ve done training and
adjusted our SOPs, but truly the best way to help the team make this
transition has been to demonstrate the value of Vault eTMF. As soon as
they see how much faster, easier, and more efficient it makes their
jobs…change is easy. There’s no turning back now,” concluded Pharma
Start President Christina Fleming.
For Additional Information:
About Pharma Start
Pharma Start provides outsourcing services, including preclinical
assessment, clinical development, clinical pharmacology, translational
medicine, medical writing, and regulatory submission and lifecycle
management, supporting global pharmaceutical, biotechnology, and
medical-device companies. For further information on Pharma Start,
About Veeva Systems
Veeva Systems Inc. (NYSE:VEEV) 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 200 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.
This release contains forward-looking statements, including statements
regarding benefits from the use of Veeva's solutions and general
business conditions. 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, 2014, which
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
1 “Study of Cloud’s Impact on Environment,” commissioned by
Accenture, Microsoft and WSP Environment and Energy, November 2010. For
® 2014 Veeva Systems Inc. All rights reserved. Veeva and the Veeva logo
are trademarks of Veeva Systems Inc. Veeva Systems Inc. owns other
registered and unregistered trademarks.
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