Theracos More Effectively Manages Both Data and Content with Medidata’s eTMF and eTMF Archive Solutions
June 27 2017 - 2:30AM
Business Wire
Medidata’s collaboration platform will allow
Theracos to seamlessly manage regulated content and actively
maintain inspection readiness
Medidata (NASDAQ:MDSO), the leading global provider of
cloud-based solutions and data analytics for clinical research,
today announced that Theracos has expanded its use of the Medidata
Clinical Cloud® to include regulated content management (RCM)
solutions, eTMF and eTMF Archive.
The increased complexity of clinical trials, coupled with
additional regulatory pressures, have significantly increased the
need for sponsors and clinical research organizations (CROs) to
efficiently maintain and extract both data and content in a
complete and compliant manner.
“The addition of Medidata’s eTMF and eTMF Archive capabilities
will allow us to collaborate across our clinical trials with
greater ease and compliance,” said Dr. Albert Collinson, president
and CEO of Theracos.
As part of the Medidata Clinical Cloud, Medidata eTMF allows
users to create, store, view, edit and collaborate on an entire TMF
life cycle in a single application with cutting-edge UX
capabilities. With live content integrity verification, life
science companies are using this fully-validated 21 CFR, Part 11
and Part 820-compliant system to assist them with their compliance
obligations.
“Our customers enjoy a unique advantage in the collection,
management and extraction of data and insights thanks to our
comprehensive clinical cloud, which encompasses all aspects of a
clinical trial,” said Mike Capone, chief operating officer at
Medidata. “In today’s environment, our unparalleled combination of
industry experience and richness of data, helps customers meet
their regulatory requirements and eliminate data and
content-related obstacles which can delay clinical trials.”
Connect with Medidata
- Read our blog, Geeks Talk Clinical
- Tweet this: Theracos adds @Medidata
eTMF and eTMF Archive capabilities to enable #clinicaltrial
collaboration and #compliance http://ow.ly/NqhL30cUkvM
- Follow us on Twitter: @Medidata
- Find us on LinkedIn
About 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 18 of the top
25 medical device developers—from study design and planning through
execution, management and reporting.
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