Medidata's Regulated Content Management Solution Leverages Box
Platform to Create the Only Content Integrity and Collaboration Platform
for Both Regulated and Nonregulated Content
NEW YORK--(BUSINESS WIRE)--
On the heels of its recent
acquisition of CHITA, Medidata
(NASDAQ:MDSO), the leading global provider of cloud-based technology and
data analytics for clinical research, today announced the availability
of its regulated content management (RCM) platform, Medidata RCM.
In collaborating with Box,
the leader in cloud content management, Medidata has expanded the Medidata
Clinical Cloud® to include breakthrough products for
standard operating procedure (SOP) management and electronic trial
master file (eTMF) archive. These unified solutions provide customers
the ability to manage all content, data and workflows in a single,
integrated platform that meets the most rigorous usability, scalability,
performance, compliance and security requirements.
The life sciences industry has historically viewed regulated content
management systems as a "painful necessity" rather than a valued tool.
Such perceptions have persisted due to outdated technology
infrastructures, disparate solutions and clunky, pre-cloud UX designs.
Yet, these systems are needed to ensure adherence to SOPs and regulatory
requirements for FDA and other regulatory body inspections.
Medidata has taken a different approach with its RCM platform. The
collaborative solution is designed to focus on the most important aspect
of advancing clinical innovation, the user, by empowering key R&D
players—sponsors, sites and contract research organizations (CROs)—to
seamlessly manage regulated content in a single, unified platform.
"Medidata RCM improves the most crucial elements of working with
regulated content in the clinical development space," said Medidata's
chief operating officer, Mike Capone. "Built with incredibly intuitive
workflows and accessible from anywhere at any time, Medidata RCM
supports our customers in complying with their legal and regulatory
requirements, while making content management and version control
easier. This streamlined environment is a major milestone for our
industry, as we provide the holistic technology infrastructure for
sponsors, sites and CROs to extract and share data in real time, and
ultimately advance scientific discovery for patients in need."
Medidata RCM is the only tool that allows users to create, store, view,
edit and jointly work on both regulated and nonregulated content in a
single application via Box's
cloud content management platform. The fully-validated 21 CFR, Part 11
and Part 820-compliant system delivers first-of-its-kind, patent-pending
live content integrity technology that actively ensures inspection
readiness for life sciences companies everywhere.
"Since implementing Medidata RCM, our users have experienced a reduction
in search and review time," said Hayley Lewis, VP of Regulatory Affairs
and Quality at Zosano Pharma. "This has allowed us to increase our
compliance. The platform is so easy to use, especially given its
integration with Box, which creates a unified search across regulated
and nonregulated content."
With one search box that is highly secure, compliant and accessible
anywhere, sponsors and CROs can find the information they need, when
they need it. With implementation timelines reduced to weeks instead of
months, Medidata RCM is as simple to set up as it is to use. And,
because Medidata RCM is pre-validated and pre-built on top of Box's
cloud-based system, the platform is only a fraction of the cost of
standard regulated content solutions.
"We are delighted that Medidata is leveraging our cloud content
management platform to break new ground in offering the life sciences
industry the ability to manage regulated and nonregulated content in one
single solution," said Jeetu Patel, CSO and SVP of Box. "This approach
gives the industry the ability to improve collaboration and efficiency
by consolidating all documents and workflows into one place."
In the future, the Medidata RCM platform will also include eTMF,
Corrective and Preventive Actions (CAPA) and other regulated document
To learn more about the challenges of managing regulated content and
Medidata RCM's unique approach, join
us for an online forum on Tuesday, May 23, 2017 from 11:00
a.m. to 1:00 p.m. ET.
Connect with Medidata
Medidata is reinventing global drug and medical device development by
creating the industry's leading cloud-based solutions for clinical
research. Through our advanced applications and intelligent data
analytics, Medidata helps advance the scientific goals of life sciences
customers worldwide, including over 850 global pharmaceutical companies,
biotech, diagnostic and device firms, leading academic medical centers,
and contract research organizations.
The Medidata Clinical Cloud® brings a new level of quality and
efficiency to clinical trials that empower our customers to make more
informed decisions earlier and faster. Our unparalleled clinical trial
data assets provide deep insights that pave the way for future growth.
The Medidata Clinical Cloud is the primary technology solution powering
clinical trials for 18 of the world's top 25 global pharmaceutical
companies and is used by 16 of the top 20 medical device developers—from
study design and planning through execution, management and reporting.
Certain statements made in this press release are "forward-looking
statements" within the meaning of the Private Securities Litigation
Reform Act of 1995 that involve significant risks and uncertainties
about Medidata Solutions, Inc. ("Medidata"), including but not limited
to statements about the expected closing of the acquisition and the
effect of the acquisition. Such statements are based on management's
current expectations and are subject to a number of uncertainties and
risks, which could cause actual results to differ materially from those
described in the forward-looking statements. For additional disclosure
regarding these and other risks faced by the Company, see disclosures
contained in Medidata's public filings with the Securities and Exchange
Commission, including the "Risk Factors" section of Medidata's Annual
Report on Form 10-K for the year ended December 31, 2015. You should
consider these factors in evaluating the forward-looking statements
included in this press release and not place undue reliance on such
statements. The forward-looking statements are made as of the date
hereof, and Medidata undertakes no obligation to update such statements
as a result of new information.
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