Medidata Solutions, Inc.
02/01/17

Medidata to Expand Its Industry-Leading Cloud Platform with Regulated Content and Document Management Capabilities

Medidata Signs Definitive Agreement to Acquire CHITA to Create Industry's First Integrated, End-to-End System for All R&D Content and Document Management Needs, Including eTMF and SOP Solutions

Strategic Partnership Agreement with Box to Bring Enterprise-Grade Content Management Capabilities to Drug Development, Accelerating Innovation with Single, Scalable Platform for Content and Data Management

NEW YORK--(BUSINESS WIRE)-- Medidata (NASDAQ:MDSO), the leading global provider of cloud-based solutions and data analytics for clinical research, today announced that it plans to add regulated content and document management capabilities to the Medidata Clinical Cloud®. In expanding its industry-leading technology platform, Medidata intends to eliminate system silos, providing customers with the ability to manage all content, data and workflows in a single, integrated platform that meets the most rigorous usability, scalability, performance and security requirements.

Medidata has agreed to acquire CHITA, a cloud-based content management and collaboration system built on Box Platform, a suite of enterprise-grade content management and collaboration APIs from Box. CHITA allows users to create, store, view, edit and jointly work on both regulated and non-regulated content in a single application with cutting-edge UX capabilities. In addition, Medidata will partner with Box to develop a suite of breakthrough products for regulated document management built on Box Platform, including electronic trial master file (eTMF) and standard operating procedure (SOP) software solutions. The new offering will be integrated into the Medidata Clinical Cloud platform, enabling life sciences organizations to view and access clinical operations data in a unified system—simplifying collaboration between sponsors, sites and contract research organizations (CROs).

"We're excited to add a new dimension to the powerful architecture that has cemented the Medidata Clinical Cloud as the industry standard for clinical trial technology driving scientific breakthroughs," said Tarek Sherif, Medidata's chief executive officer. "The life sciences industry has long struggled with manual, siloed processes for document and content management, creating significant challenges that delay trial timelines and impact overall time to market. Adding document and content management solutions to our platform—leveraging the combined strengths of Medidata, CHITA and Box—will address those challenges, delivering a seamlessly integrated and intuitive user experience. Together, these solutions will provide access to real-time data, enhance collaboration between sponsors, sites and CROs, and accelerate execution to ultimately speed up drug development and the delivery of new medicines to patients."

Box is a leader in enterprise content management for payors, providers and global life sciences companies around the world. Over 69,000 businesses trust Box to manage and secure critical information in the cloud, including leading life sciences companies GSK, AstraZeneca, Boston Scientific and Edwards Life Sciences. Headquartered in Redwood City, CA with offices worldwide, the company supports the digital transformation of over 650 life sciences organizations, including 12 of the top 15 global pharmaceutical, CROs, medical device and biotechnology companies.

"The need for organizations to operate in a modern way is more important than ever before," said Jeetu Patel, chief strategy officer and SVP of Box. "The highly regulated life sciences industry requires the most advanced security and enterprise-grade tools, and we're excited to partner with Medidata to enable the creation of clinical solutions built on Box Platform that manage both regulated and non-regulated content all in one single application."

Kevin Barrett, CEO of CHITA, added, "Our vision for CHITA stemmed from a keen understanding of the intricacies and pain points of content management in clinical trials today. That's why we worked closely with Box to develop an integrated, extremely intuitive and user-friendly system that can accommodate all document types, both regulated and non-regulated. Now, in joining Medidata—the industry's leading clinical trial technology company and a trusted strategic partner to nearly 800 life sciences companies worldwide—we are able to enhance our offering even further, leveraging Medidata's deep industry expertise to break into the eTMF market."

Founded by life sciences technology veterans from Elan Corporation, blended with world-class experience in cloud-based content management, CHITA provides a unique way to securely create, collaborate, manage and share documents, as well as comprehensively search across all files, in real time. The solution is also accessible via an easy-to-use mobile app, simplifying on-the-go document management workflows. CHITA's secure, fully-validated system is 21 CFR, Part 11 and Part 820-compliant, and provides pre-configured SOPs and built-in training tools for streamlined user compliance validation and assurance.

The purchase agreement between Medidata and CHITA includes purchasing CHITA's parent holding company for an undisclosed all-cash initial purchase price, along with earnout payments contingent on the performance of the business. The completion of the CHITA acquisition remains subject to customary closing conditions, and is expected to close during February 2017.

Connect with Medidata

About Box

Founded in 2005, Box (NYSE:BOX) is transforming the way people and organizations work so they can achieve their greatest ambitions. As a leading enterprise content platform, Box helps more than 69,000 businesses, including AstraZeneca, General Electric, P&G and The GAP securely access and manage their critical information in the cloud. Box is headquartered in Redwood City, CA, with offices across the United States, Europe and Asia. To learn more about Box, visit http://www.box.com/.

About CHITA

CHITA is introducing a breakthrough content management and collaboration platform that is fully integrated with Box platform that will allow users to create, store, view, collaborate on and edit both regulated and non-regulated content in a single application. CHITA is 21CFR, Part 11 and Part 820-compliant and provides the ideal environment for life sciences workflow management. It also features pre-configured Standard Operating Procedures (SOPs) and Read & Acknowledge training record management. This new solution is designed to address the significant hurdles inherent in compliance validation and assurance, helping life sciences companies to manage their content needs more effectively.

About Medidata

Medidata is reinventing global drug 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 nearly 800 global pharmaceutical companies, innovative 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 17 of the world's top 25 global pharmaceutical companies, from study design and planning through execution, management and reporting.

Cautionary Statement

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.

Medidata Solutions
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Source: Medidata Solutions

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