More than 50 life sciences organizations move to Veeva Vault eTMF for
complete access, visibility, and control of TMF content and processes
PLEASANTON, Calif.--(BUSINESS WIRE)--
In the face of increasing clinical trial cost and complexity and
changing regulatory guidelines, life sciences companies are turning to
cloud-based Veeva Vault eTMF to improve clinical trial master file (TMF)
timeliness, completeness, and inspection readiness. In just over a year,
five of the world’s top 20 pharmaceutical companies have standardized on
Veeva Vault eTMF, joining more than 50 Vault eTMF customers – from
emerging biotechs to CROs and large pharmas – gaining better access,
visibility, and control over clinical trial content and processes.
Regulatory authorities worldwide are placing higher levels of scrutiny
on the TMF. The United Kingdom’s Medicines and Healthcare Products
Regulatory Agency (MHRA) updated its definition of a critical good
clinical practice (GCP) finding to include trial master files that are
incomplete and inaccessible. There is also a growing recognition of the
role TMF management can have in speeding time to market. These changes
have prompted an increased focus on actively managing the clinical trial
master file throughout the trial process.
Lacking deep, industry-specific capabilities for TMF collaboration,
collection, and management, many eTMFs today are simple file shares that
serve as document storage. To increase efficiency while strengthening
inspection readiness, companies are moving toward process-driven eTMF
applications—and seeing major benefits. Those using advanced eTMF
technologies report greater audit readiness, visibility, compliance, and
cost savings from their eTMF than those using local or cloud file
systems.1
“A major transformation in TMF management is underway,” said
Jennifer
Goldsmith
, vice president of Veeva Vault. “The industry is rapidly
moving away from TMFs as simple, static archives. Companies are
utilizing TMFs more strategically to improve trial management and
long-term trial design and planning, allowing them to bring products to
market more quickly and efficiently.”
By proactively guiding processes, quality, and visibility at every
stage, Vault eTMF is helping companies streamline the clinical
development process from start to finish. “Veeva Vault eTMF is becoming
the standard for the industry,” said Jaime O’Keefe, vice president of
Paragon’s R&D practice. “Before Veeva, a typical eTMF implementation
took 12 to 18 months and only produced a document archive. With Veeva
Vault eTMF, implementations take a fraction of the time, and
organizations gain an eTMF application that manages process, provides
global collaboration, and ensures inspection-readiness.”
Veeva Vault eTMF is part of Veeva Vault, a cloud-based content
management platform and suite of life sciences-specific applications.
Vault eTMF enables real-time collaboration between external partners,
internal teams across clinical and regulatory, and study sites globally
to deliver a single source of the truth for content. It eliminates the
risk and ineffectiveness of manual processes, improving efficiency,
visibility, and control. Additionally, Vault eTMF’s comprehensive
reporting and configurable dashboards provide actionable insights to
drive ongoing clinical trial improvement and ensure inspection readiness
at all times, in compliance with global health authorities.
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 life sciences companies rely upon Vault to manage their
most important content.
Additional Information:
• For more information on Veeva Vault, please visit: www.veeva.com/vault/
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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 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 the Veeva Vault eTMF product, the results
from use of the Veeva Vault eTMF product, 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, 2014, which is available on the
company’s web site 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.
1 Veeva Systems, “Veeva 2014 Paperless TMF Survey: An
Industry Benchmark,” October 2014. http://www.veeva.com/tmf-survey-2014/.
Source: Veeva Systems Inc.