Partnerships in Clinical Trials has named Parexel's Drew Garty, senior director, product management, the 2015 Clinical Innovator of the Year. The award recognizes Garty's leadership of the product development team for the company's Perceptive MyTrials Data-Driven Monitoring solution.
On-site monitoring is a critical aspect of trial management, with the primary function of identifying and mitigating patient safety or data quality risks at investigative sites. The FDA and other regulatory bodies have issued guidance to assist sponsors in developing risk-based monitoring strategies. The goal of these strategies is to enhance patient protection and improve trial data quality through more effective study oversight.
The Perceptive MyTrials Data-Driven Monitoring solution uses a unique algorithmic-based approach to clinical monitoring to determine risk and monitor workload, enabling flexible and scalable decision making. Data-driven monitoring allows drug developers to accurately identify study risks and efficiently determine the most effective monitoring interventions required. As a result, drug developers can enhance quality and patient safety, reduce costs and ensure regulatory compliance.
"Through the Perceptive MyTrials Data-Driven Monitoring solution, we have greater insights into study data. These insights can make clinical trial participation safer for patients, improve decision making during the drug development journey and offer cost efficiencies for sponsors," said Xavier Flinois, president of Parexel Informatics. "Our data-driven monitoring solution builds on Parexel’s established history of developing innovative technologies to continuously improve clinical processes, and we are thrilled to be recognized by Partnerships in Clinical Trials."