Medidata, a global provider of cloud-based solutions for clinical research in life sciences, is partnering with TransCelerate BioPharma 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 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 risk-based monitoring of 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 global life science R&D organizations—established five initial projects including the Risk Based Monitoring (RBM) initiative. Following draft guidance from the FDA and the EMA, TransCelerate released a position paper in June 2013 and an update in early 2014 outlining an approach for RBM that can be adopted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.
"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.
The analysis is being conducted leveraging Medidata's 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.
Medidata's platform offers Medidata TSDV and Medidata SQM tools to support RBM. "Risk-based monitoring is clearly the direction for the future," de Vries said. "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."