Medidata Solutions, Inc.

Theracos More Effectively Manages Both Data and Content with Medidata's eTMF and eTMF Archive Solutions

Medidata's collaboration platform will allow Theracos to seamlessly manage regulated content and actively maintain inspection readiness

NEW YORK--(BUSINESS WIRE)-- 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."

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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.

Medidata Solutions
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Erik Snider, +1 646-362-2997

Source: Medidata

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