Global biopharmaceutical company enables real-time inspection
readiness and improves CRO collaboration
PLEASANTON, Calif.--(BUSINESS WIRE)--
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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Source: Veeva Systems Inc.