NEW YORK, N.Y. – December 10, 2014 – Medidata (NASDAQ: MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, today announced the availability of its enriched solution for risk-based monitoring (RBM) of clinical trial sites. The company’s previously announced acquisition of Patient Profiles, an early-stage software company focused on improving clinical trial data quality, broadens Medidata’s best-in-class technology for RBM, a proven methodology for reducing trial costs while providing a higher level of clinical data accuracy and quality.
“Working with Patient Profiles has given Biotie Therapies Inc. the ability to understand complex interrelated datasets and target our monitoring needs, enhancing the quality of our data reviews while increasing the efficiency of our clinical trials,” said Steve Bandak, Chief Medical Officer at Biotie Therapies Inc., a customer of Patient Profiles. “At a time when risk-based monitoring is moving from theory to practice, it’s exciting to see Patient Profiles join such an innovative organization as Medidata, enabling them to further improve the way the industry conducts clinical research.”
Founded by two former FDA statistical reviewers, Barbara Elashoff and Michael Elashoff, Patient Profiles is now available as a consulting service to Medidata customers. The Patient Profiles offering adds visualized monitoring analytics around subject and site data, providing immediate insight into clinical trial site performance and data quality. Its user-friendly software platform utilizes proprietary algorithms to predict where data errors may occur during studies, and then automatically adjusts risk indicators to allow for early detection of anomalies and outliers in clinical data—including potential fraud and misconduct.
The Patient Profiles offering will be integrated into the Medidata Clinical Cloud® as part of Medidata RBM. A comprehensive, systematic approach to risk-based monitoring, Medidata RBM includes a robust combination of technology, analytics and hands-on strategic consulting services that enable life science organizations to quickly realize the quality, cost and timeline benefits of a RBM program. Through the automated review of clinical data captured in Medidata’s cloud-based electronic data capture and management system (Medidata Rave®), the addition of Patient Profiles makes Medidata RBM the first cloud-based solution to provide centralized monitoring analytics using both operational data (e.g., key risk indicators, such as adverse event rates and query cycle times) and patient data.
“With its focus on centralized monitoring, Patient Profiles complements our existing risk-based monitoring offering by providing a set of tools to help monitoring teams be more targeted in their approach and identify anomalies in clinical data,” said Glen de Vries, Medidata’s president. “We’re excited about enriching our platform with these capabilities and welcoming the Patient Profiles team to Medidata.”
Along with its capabilities around site performance and data quality, the Patient Profiles offering also includes a highly configurable reporting tool that integrates data points from disparate sources and organizes them into individual patient-centric reports. The reports make it easier for clinical teams to detect critical data changes, such as those that may indicate potential adverse events.
“Risk-based monitoring is such a key area for Medidata and the industry because of its ability to improve data quality and lower monitoring costs,” de Vries added. “Integrating Patient Profiles into our platform is part of our focus on continual innovation and further enhances our easy-to-use, holistic RBM offering, which is helping sponsors and their CRO partners improve operational efficiencies and decision making throughout the clinical trial lifecycle.”
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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.