Risk-Based Algorithm helps Clinical trial monitoring

A new report from PricewaterhouseCoopers (PwC) found that the use of a risk-based algorithm to monitor clinical studies reduced the deployment of research associates and targeted more high-risk patients and sites.  Although CROs and sponsors have been hesitant to use more risk based approaches, the PwC report estimates that risk-based monitoring can save between 15% and 20% in study portfolio cost.  There is a broad range of risk based monitoring available and the FDA guidance from late 2011, entitled “Oversight of Clinical Investigations – A Risk Based Approach to Monitoring” suggested that sponsors rely less on on-site monitoring and use a more centralized approach. To read the full article from outsourcing-pharma.com, click here.  Contact us at 317-899-9341 to help with your clinical trial monitoring.