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Collaboration to explore key components of recommended Risk-Based Monitoring methodology
Medidata (NASDAQ: MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, today announced that it is partnering with TransCelerate BioPharma Inc. ("TransCelerate") on a project designed to inform the nonprofit organization’s continued efforts to modernize and streamline the way clinical trials are conducted and monitored worldwide.
Leveraging the robust operational data available through the Medidata Clinical Cloud™, Medidata is providing metrics and analytics to help TransCelerate answer important questions posed by the industry regarding the benefits and challenges associated with a risk-based approach to monitoring of clinical trial sites. Specifically, the analysis will more rigorously assess the relative contribution of source document verification (SDV) to overall clinical data quality. The findings will be analyzed with the intent of publishing the results in a paper co-authored by TransCelerate and Medidata. ―By leveraging Medidata’s expertise and breadth of clinical trial data, we will be able to provide further evidence to support the approach TransCelerate outlined for high-quality risk-based monitoring of clinical trials, said Rehbar Tayyabkhan, RBM project lead for TransCelerate.
The largest initiative of its kind dedicated to improving drug development, TransCelerate—and member companies comprising most of the world’s leading, global life science R&D organizations—established five initial projects including the Risk Based Monitoring (RBM) initiative. Following draft guidance from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), TransCelerate released a position paper in June 2013 and an update in early 2014 outlining an approach for RBM that can be adopted for any type, phase and stage of a clinical trial. The framework provided includes tools and triggers to help the industry identify and categorize risks. (For more information, please visit http://www.transceleratebiopharmainc.com.)
"Medidata shares TransCelerate’s commitment to modernizing clinical trials in order to speed up the delivery of safe, new therapies to patients," said Glen de Vries, Medidata’s president. "We are thrilled to work with TransCelerate and delighted to help the consortium leverage our rich data and analytics capabilities."
The analysis is being conducted leveraging Medidata’s comprehensive business analytics solution (Medidata Insights™), which comprises data—collected over the last five years—from over 7,000 clinical trials across the globe involving more than 120 sponsor organizations.
In addition to valuable benchmarking data and industry analytics, Medidata’s technology platform offers easy-to-use tools (Medidata TSDV and Medidata SQM) to support RBM. These capabilities are part of the broad set of cloud-based solutions Medidata has designed to help clients improve operational efficiencies, capture resource savings and enhance decision making throughout the trial lifecycle.
"Risk-based monitoring is clearly the direction for the future," de Vries added. "Embracing this methodology and technology to support it will help sponsors and CROs improve project oversight, make smarter trial decisions, gain efficiencies across clinical operations and reduce costs, all while supporting patient safety, data integrity and compliance."