Medidata Risk-Based Monitoring Solution Selected


Company News Release

Increased Adoption of the Medidata Clinical Cloud® Enables Safer, Faster and More Insightful Clinical Trials

NEW YORK, N.Y. – November 23, 2015 – Medidata (NASDAQ: MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, today announced that Infinity Pharmaceuticals, Inc., a biopharmaceutical company dedicated to the discovery, development and delivery of medicines for difficult-to-treat diseases, has expanded its use of the Medidata Clinical Cloud®. A long-standing Medidata customer, Infinity will now utilize Medidata’s best-in-class solution for risk-based monitoring (RBM)-a proven methodology for reducing trial costs while providing a higher level of data quality-in an upcoming Phase III oncology study for patients with indolent non-Hodgkin lymphoma.

“As strong proponents of risk-based monitoring, we share Medidata’s vision and are pleased to be incorporating their comprehensive RBM solution into our clinical study,” said Ross Pettit, senior vice president of development operations at Infinity. “Medidata continues to be a trusted and seasoned advisor, enabling us to leverage cutting-edge technology and process optimization in our clinical trial programs. We look forward to making the most of Medidata’s expertise as we take a holistic approach to risk-based monitoring.”

Based in Cambridge, Massachusetts, Infinity focuses on the research and development of potential cancer therapies. Infinity has been a Medidata customer since 2005, utilizing the company’s cloud-based technology for electronic data capture and management (Medidata Rave®) and medical coding (Medidata Coder®) across its pre-clinical and Phase I-III development programs. To further advance its drug development strategy and outsourcing model, Infinity is leveraging the robust combination of technology and analytics within Medidata RBM-including centralized statistical analytics, targeted source document verification (TSDV), and study and site level key risk indicators (KRIs).

Supported by regulatory agencies-including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA)-as well as the non-profit industry group TransCelerate BioPharma Inc., risk-based monitoring allows clinical trial sponsors to identify and prioritize resources around key areas of risk, such as patient safety and data quality and integrity. The robust tools within Mediata RBM enable targeted and centralized monitoring techniques by providing visualized analytics around subject and site data, guided by data anomaly and pattern detection as well as KRIs in real time. Additionally, Medidata’s unified electronic data capture (EDC) and RBM solution streamlines study start-up and provides a single source of truth for patient and operational data-leading to better visibility into patient enrollment, site performance and overall data quality.

“Medidata has long championed incorporating risk-based monitoring into clinical development programs, and we’re excited to grow our partnership with Infinity as they adopt this valuable methodology,” said Mike Capone, Medidata’s chief operating officer. “We're proud that our platform and deep industry knowledge are furthering Infinity’s efforts to reduce trial timelines, increase productivity and quickly access meaningful data, working toward the goal of driving efficiencies that can accelerate the delivery of new treatment options for cancer patients everywhere.”

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About Medidata
Medidata is the leading global provider of cloud-based solutions for clinical research in life sciences, transforming clinical development through its advanced applications and intelligent data analytics. The Medidata Clinical Cloud® brings new levels of productivity and quality to the clinical testing of promising medical treatments, from study design and planning through execution, management and reporting. We are committed to advancing the competitive and scientific goals of global customers, which include over 90% of the top 25 global pharmaceutical companies; innovative biotech, diagnostic and device firms; leading academic medical centers; and contract research organizations.

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