samedi 8 août 2020


Veeva Announces EDC and eSource to Transform Clinical Data Management

Par Rédaction , dans Communiqués , le 13 octobre 2016

Thursday, October 13th 2016 at 11:03am UTC

Veeva Vault EDC and Veeva Vault eSource to improve the speed and
quality of data to cut cost and complexity in clinical trials

PLEASANTON, Calif.–(BUSINESS WIRE)– Veeva
Systems
(NYSE:VEEV) today introduced Veeva
Vault EDC
and Veeva
Vault eSource
, the first applications for clinical data management
on a single cloud platform. Together with Vault
CTMS
, Vault
eTMF
, and Vault
Study Startup
, Veeva is expanding the Veeva
Vault Clinical Suite
, the industry’s only suite of unified cloud
applications to streamline clinical operations and data management, from
study startup to archive.

In less than four years, Veeva has added more than 120 clinical
operations customers, including global deployments of Veeva
Vault eTMF
at seven of the top 20 pharma companies. Veeva is
building upon its track record of innovation and customer success by
delivering a modern cloud approach for clinical data management with
Vault EDC and Vault eSource. Now life sciences companies will get the
high quality data they need faster to accelerate trials.

Since 2000, the volume of data in a Phase III study has risen by more
than 50% and the cost per patient for a clinical trial has almost
doubled.1 Traditional electronic data capture (EDC) systems
add to this complexity and cost by requiring site staff to spend a
significant amount of time managing clinical data. System set-up,
maintenance, inflexibility, and a lack of integration have slowed down
the pharmaceutical industry’s ability to get clean data and quickly make
informed, confident decisions during trials.

“The drug development process is fraught with delays and inefficiencies
due in large part to protocol complexity, operating fragmentation, and
the use of disparate point solutions,” said Ken Getz, associate
professor and director at Tufts University School of Medicine. “The
integration of clinical practice and clinical research data, next
generation eClinical technology solutions that unify end-to-end clinical
processes, and improvements in protocol design execution feasibility
will all be critical success factors in driving higher levels of
efficiency, performance, and data quality.”

Vault EDC will be a modern and adaptive cloud application and
purpose-built for trial processes to speed critical workflows and enable
real-time feedback. It will provide an intuitive, consumer-friendly
experience for sites, sponsors, and CROs to quickly and easily access
data, and be a single point of focus for clinical data and facilitate
all trial designs, from the simplest to the most complex.

Customers can deploy Vault EDC as a standalone application or integrate
electronic source data (eSource) with Vault eSource to record patient
data directly into an easy-to-use mobile application. This will not only
eliminate the need to manually transcribe patient data into an EDC
system – which can be days or weeks after the patient visit – but will
also cut costly and time-consuming onsite source data verification by
clinical monitors.

Vault EDC and Vault eSource will be built upon an open cloud
architecture that allows them to be used with other third-party clinical
systems. When used together, Veeva will offer the first and only
integrated solution on a single platform to ensure high quality data at
the point of entry in eSource all the way through to the EDC system,
helping streamline clinical processes and speed product time-to-market.

“The industry has been forced to settle for clinical data management
systems that have been short on innovation and high on complexity,” said
Henry Levy, chief strategy officer at Veeva Systems. “Vault EDC and
Vault eSource will offer an innovative, integrated approach that will
deliver the data quality and real-time access that is needed to make
faster, informed decisions and cut the cost and complexity of trials.”

Today’s news signals Veeva’s focus and investment in this important
market – which is estimated to be $1 billion globally for EDC alone – to
manage clinical data more efficiently and effectively.2 The
expense impact of this new initiative was reflected in the company’s
guidance for fiscal year 2017.

The Veeva Vault Clinical Suite will now include Vault EDC and Vault
eSource along with Vault CTMS, Vault eTMF, and Vault Study Startup to
become the most comprehensive suite of clinical cloud applications on a
single platform. For the first time, life sciences companies can unify
clinical operations and data management to streamline end-to-end
processes.

In other news, Veeva expanded its clinical leadership team, adding to
its already deep expertise in cloud software development, to deliver
continued innovation that will solve customers’ most strategic
challenges in clinical. Read today’s press
release
to learn more.

Availability

Veeva Vault EDC is expected to be available in April 2017, while Veeva
Vault eSource is expected to be available in December 2017.

Additional Information

For more on Veeva Vault EDC, visit: veeva.com/VaultEDC

For more on Veeva Vault eSource, visit: veeva.com/VaulteSource

Connect with Veeva on LinkedIn: linkedin.com/company/veeva-systems

Follow us @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 450 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.

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, 2016. 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.

1 Ken Getz, Clinical Trial Complexity (Tufts: November 2012)
and Penelope K. Manasco, M.D., 10 Things to Speed Development, Lower
Costs, and Enhance Quality with Existing Clinical Budgets (MANA RBM:
2016)

2 Transparency Market Research, E-Clinical Solution Software
Market: Global Industry Analysis, Size, Share, Growth, Trends and
Forecast 2014-2020

Contacts

Veeva Systems
Roger Villareal, 925-264-8885
roger.villareal@veeva.com
or
Lisa
Barbadora, 610-420-3413
pr@veeva.com

Source: Veeva Systems Inc.

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