Global biopharmaceutical company enables
real-time inspection readiness and improves CRO collaboration
Veeva Systems (NYSE: VEEV) announced today that Debiopharm
International SA, part of Swiss-based biopharmaceutical company
Debiopharm Group™, selected Veeva Vault eTMF to improve oversight
across its trial master file (TMF) processes and work closely with
contract research organizations (CROs) by collaborating on a
single, cloud-based application.
“Veeva is helping us streamline our clinical operations,” said
Christian A. Aeschlimann, director of clinical operations at
Debiopharm. “Veeva Vault eTMF will help us maintain an
always-accurate, up-to-date TMF and align with external partners by
working in the same system.”
As a sponsor, Debiopharm is required by ICH E6(R2) to maintain
oversight throughout clinical trials. External partners were unable
to access the company's previous, on-premise eTMF, so CROs used
their own systems and transferred documents periodically. This
meant that Debiopharm did not have full, real-time visibility into
the CROs’ TMF activities.
Veeva Vault eTMF provides a single source of truth for trial
documentation. Sponsors and CROs can manage TMF documents and
processes in the same system, in real-time, as they are being
executed. Now Debiopharm can keep its TMF in a constant state of
inspection readiness and ensure partners adhere to its standard
operating procedures.
“In our quest for continuous improvement, we selected Veeva
Vault eTMF to help us work more efficiently and maintain high
quality trial documentation,” said Vincent Demeautis, clinical
operations manager at Debiopharm. “Sharing a single system with
CROs to drive all TMF processes will eliminate the need to manage
and reconcile multiple TMF sources while improving our
responsiveness and collaboration with external and internal study
team members.”
Veeva Vault eTMF will also provide Debiopharm with reports and
dashboards for visibility into TMF completeness, timeliness, and
accuracy. This will help the company to check the status and
quality of documentation and proactively resolve any issues that
arise.
"Veeva Vault eTMF was the best solution on the market to meet
our current and future needs," said Sofie Lemmens, senior clinical
trial associate at Debiopharm, who led the implementation of Veeva
Vault eTMF. "It was a critical investment across our internal teams
to improve TMF quality and access."
By adopting Veeva Vault eTMF, Debiopharm has taken its first
step toward a unified clinical model to streamline end-to-end
processes and systems, increase collaboration, and improve
performance across trials. This reflects an industrywide shift,
with nearly all (99%) respondents to the Veeva 2017 Unified
Clinical Operations Survey reporting the need to unify their
clinical operations.
“Sponsors are unifying systems and processes to improve study
quality and execution while managing a growing number of trials and
increasing complexity across the clinical lifecycle,” said Rik Van
Mol, vice president, R&D Strategy, Europe at Veeva. “Veeva
Vault eTMF lets Debiopharm improve trial visibility and compliance
as well as begin a journey toward unified clinical operations.”
Veeva Vault eTMF is part of Veeva Vault Clinical Suite, the
industry's first suite of applications that combines eTMF with EDC,
CTMS, and study start-up to unify clinical data management and
operations. To learn how organizations are eliminating system silos
across clinical operations with Veeva Vault Clinical Suite, visit
veeva.com/Clinical.
Additional Information
For more on Veeva Vault eTMF, visit: veeva.com/eTMF
Connect with Veeva on LinkedIn:
linkedin.com/company/veeva-systems
Follow @veevasystems on Twitter: twitter.com/veevasystems
Like Veeva on Facebook: facebook.com/veevasystems
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 600
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.
About Debiopharm International SA
Part of Debiopharm Group™ – a Swiss-headquartered global
biopharmaceutical group including five companies active in the life
science areas of drug development, GMP manufacturing of proprietary
drugs, diagnostic tools and investment management – Debiopharm
International SA is focused on the development of prescription
drugs that target unmet medical needs. The company in-licenses and
develops promising drug candidates. The products are commercialized
by pharmaceutical out-licensing partners to give access to the
largest number of patients worldwide. For more information, please
visit debiopharm.com or follow @DebiopharmNews on Twitter.
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
October 31, 2017. 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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version on businesswire.com: https://www.businesswire.com/news/home/20180417005598/en/
Veeva SystemsRoger Villareal,
925-264-8885roger.villareal@veeva.comorLisa Barbadora,
610-420-3413pr@veeva.comorDebiopharm International
SAChristelle von Büren, +41 (0)21 321 01
11christelle.vonburen@debiopharm.com
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