The Parexel tool offers a new approach to centralized risk-based monitoring as it can capture, consolidate and organize clinical information in real-time from disparate sources. Drug developers using the tool will be able to accurately identify study risks and rapidly determine what type of intervention may be required. Monitoring focused on specific risk offers the potential to enhance patient safety, reduce costs and promote regulatory compliance, Parexel says.
Developed by the company’s flagship Parexel Informatics, the tool will be a key component of the company’s eClinical platform.
“Perceptive MyTrials Data-Driven Monitoring uses clinical data to guide monitoring activities as an alternative to periodically scheduled monitoring visits, which can be time-consuming, costly and inefficient,” said Xavier Flinois, President of PAREXEL Informatics. “Greater insight into study data allows for a more precise determination of when on-site monitoring visits need to occur and what activities should be undertaken during those visits.”
Push to risk-based monitoring
As the US FDA and other regulators encourage the greater use of centralized monitoring for trials, more CROs are looking at ways to improve oversight of studies with a more hands-off approach.
Recent FDA guidance indicates ways that companies can use more targeted and remote risk-based monitoring. But uptake seems slow as companies remain averse to any sort of risks that could impact a trial’s success.
Experts previously told us that risk-based monitoring can be most effective for Phase II and IV studies, though CROs’ business model can be dependent on on-site monitoring for revenue.
Sponsors, however, may be cautious with CRO monitoring as the FDA has made it clear that sponsors are ultimately responsible for a trial even if monitoring duties have been delegated to the CRO.