Medidata Introduces New Strategic Monitoring Suite to Ensure Sponsors and Sites Meet ICH E6 Guidelines

Sites, Sponsors and CROs are facing increased costs and regulations in the area of monitoring. For studies conducted by CROs alone, monitoring accounts for nearly 50% of the cost of clinical trials - that's approximately $12 billion annually. In 2016, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use released guidelines, ICH E6 (R2) GCP, requiring sponsors to adopt a risk-based monitoring (RBM) framework, including statistical data quality checks. Today, Medidata (NASDAQ: MDSO) announced the launch of its Strategic Monitoring suite, which meets ICH E6 guidelines and exceeds requirements by empowering clinical research teams to collaborate and manage all cross-functional, risk management and centralized data monitoring activities through seamless, end-to-end workflows.

Medidata, the leading global provider of cloud-based solutions for clinical research in life sciences, introduced Medidata Strategic Monitoring during a keynote at its NEXT Global event- where science meets technology meets the future. A new offering within the Medidata Clinical Cloud®, the Strategic Monitoring suite is the first and only industry solution that defines and executes a holistic, workflow-driven monitoring approach, enabling sponsors and CROs to identify risks and document actions in real-time.

Without a streamlined solution to help sponsors and sites manage the new ICH E6 guidelines, activities to date have been siloed when implementing RBM, with clinical research associates (CRAs) managing the entire quality analysis through repetitive, manual processes. Medidata, in conjunction with Life Science Strategy Group, Inc., recently conducted a double-blinded survey of 70 end users and decision-makers of RBM technology and asked them to rate the major vendors. Medidata’s original RBM offering was already one of two vendors with top ratings for both Product and Professional Services implementation. Now, by integrating Medidata Strategic Monitoring into a seamless cloud platform featuring advanced analytics, Medidata is positioned to lead and transform monitoring throughout clinical research.

"We created Medidata Strategic Monitoring after carefully reviewing the regulatory position papers, ICH Guidelines and TransCelerate RBM technology requirements," said Kyle Given, managing director, strategic monitoring, Medidata. "This system was designed to create a unified analytics platform for centralized monitoring, enabling sponsors and CROs to identify patient, site and study level risks, and implement a set of traceable corrective actions that helps sites comply with protocol requirements; ensuring patient safety."

Medidata Strategic Monitoring is the first and only suite that uses machine learning for adaptive monitoring, ensuring enriched data quality through early, real-time, unique insights. The new solution integrates directly with Medidata Rave® and the Medidata platform; able to be deployed on studies directly on the Medidata Clinical Cloud.

A number of Medidata customers, including sponsors and CROs, are already committed to implementing Medidata Strategic Monitoring; which will be easily integrated into their current use of the Medidata cloud platform, supporting site efficiency and ensuring sponsors meet study timelines.

Glen de Vries, president, Medidata, added: "Medidata’s cloud platform facilitates a comprehensive approach to risk-based monitoring, in an intuitive interface, and with full compliance to regulatory guidelines and industry best practices. Medidata is the only platform today that provides a complete solution to clinical operations for sponsors and CROs; fully integrated with scientific data management workflows focused on patient outcomes.”

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 950 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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