Veeva Systems Unveils Clinical Trials Study Start-Up Solution

Barcelona, Spain (ots/PRNewswire) -

Top 20 pharma and top 10 global CRO sign on as first Veeva Vault
Study Start-Up

customers

At the Veeva 2015 R&D Summit today, Veeva Systems announced the
first fully integrated clinical trials study start-up solution. Veeva
Vault Study Start-Up will enable life sciences organizations to
manage both the content and the activities associated with activating
sites for clinical trials. This comprehensive solution will
accelerate time to first patient enrollment, automate manual
processes, and deliver seamless interoperability with eTMF for a
single source of trial-related content.

(Logo: http://photos.prnewswire.com/prnh/20120425/527164 )

Life sciences organizations have made strides in adopting advanced
solutions to increase speed and efficiency in many areas of the trial
process. According to the 2015 TMF Reference Model Survey [https://tm
frefmodel.files.wordpress.com/2015/10/2015-tmf-survey-overview.pdf ],
a majority of respondents (61%) are either using or actively planning
on using an eTMF. And according to the Veeva 2015 Paperless TMF
Survey [http://go.veeva.com/tmfsurvey2015 ] , speeding study start-up
is cited by 56% of the respondents as a top driver of eTMF adoption
in their organization.

"The life sciences industry has long struggled with manual and
inefficient processes for study start-up," said Kathryn King, vice
president of Vault Clinical at Veeva. "Existing solutions managed
either documents or start-up activities, but never both together.
This created significant challenges in identifying and addressing
issues during start-up, resulting in longer study durations and
impacting overall time to market."

Traditional solutions exacerbated the problem by focusing on
either site start-up documentation or site initiation data, but were
unable to bring the documents and data together. Further, these
systems were often disconnected from the eTMF applications that also
needed that information as part of the trial's history. The
fragmented landscape contributed to lengthy site initiation
timelines, a process that, on average, took 17 months to complete
according to research from the Tufts Center for the Study of Drug
Development.

"Sponsors and CROs have typically used unsophisticated, disparate,
and incompatible proprietary and customized approaches and eClinical
solutions to manage study start-up and initiation activities," said
Ken Getz, associate professor at CSDD Tufts University School of
Medicine. "This has contributed to the historically high level of
inefficiency and inconsistency that we've observed in investigative
site engagement and activation."

Vault Study Start-Up will bring together site start-up documents
and site initiation in a single solution, while providing seamless
interoperability with Veeva Vault eTMF
[https://www.veeva.com/products/rd-cloud/vault-etmf ] . This
combination of capabilities will ensure a single source of truth for
all start-up related content and data. Sites, sponsors, and CROs will
be able to access the same clinical information, simplifying
collaboration and increasing efficiency. Vault Study Start-Up will
also provide advanced capabilities to better manage start-up
processes, including a complete, reliable electronic audit trail.

Veeva Vault Study Start-Up will be available in early December
2015. A top 20 pharmaceutical company and a top 10 global CRO have
already signed on as early Vault Study Start-Up customers.

Veeva Vault RIM [https://www.veeva.com/products/rd-cloud/vault-rim
] was also announced today [https://www.veeva.com/resources/new-rim-s
olution-will-unite-registration-information-documents-and-dossiers-to
-transform-regulatory-operations-globally ] at the 2015 Veeva R&D
Summit. Vault RIM is a next-generation regulatory information
management suite that unites submission documents, published
dossiers, product registrations, and agency commitments into a single
authoritative source for the global organization. For details, or to
arrange an interview, contact pr@veeva.com

Additional Information

- Stay updated on the latest Veeva news on LinkedIn:
linkedin.com/company/veeva-systems
[http://www.linkedin.com/company/veeva-systems ]

- Follow @veevasystems on Twitter: twitter.com/veevasystems
[https://twitter.com/veevasystems ]

- Like Veeva on Facebook: facebook.com/veevasystems
[http://www.facebook.com/veevasystems ]

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, regulatory, 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 190
customers rely upon Vault to manage their most important content.

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 300 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 http://www.veeva.com/eu.

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
July 31, 2015. This is available on the company's website at
http://www.veeva.com/eu under the Investors section the SEC's website
at http://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.

Contact:
Sue Glanville / Cate Bonthuys
Veeva Systems Inc.
sue@catalystcomms.co.uk / cate@catalystcomms.co.uk

Photo:
http://photos.prnewswire.com/prnh/20120425/527164

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