Xavier Flinois, president of PAREXEL Informatics.
Biopharma services provider PAREXEL International has expanded its Perceptive MyTrials data-driven monitoring (DDM) solution with next generation risk-based monitoring capabilities.
MyTrials now further enables clients to perform cross-study analysis of quality, risk and monitoring work effort by combining analytics, reporting and monitoring activity into a single cohesive solution. The enhancements increase a drug developer’s ability to demonstrate appropriate oversight and control of site-related risk, quality and performance while simplifying monitoring governance and execution.
“Centralised monitoring methods are being encouraged by the US Food and Drug Administration (FDA) and other regulatory bodies. By combining our DDM and monitoring solutio
n, PAREXEL clients now have the ability to bridge real-time information gaps between centralised analysts and in-the-field monitoring teams, reducing risk, ensuring documentationand increasing quality,” said Drew Garty, senior director, product management, PAREXEL.
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. Developed by PAREXEL Informatics, it is a key component of the Perceptive MyTrials platform, an integrated suite of applications for managing clinical trials.
“Our enhanced data-driven monitoring solution provides users with greater control over site risk and resourcing, building on PAREXEL’s long-standing track record of developing innovative technologies to continuously improve clinical processes,” said Xavier Flinois, president of PAREXEL Informatics. “These updates are the latest example of our continued commitment to make the drug development process more efficient for our clients.”