Risk Based Monitoring through a holistic evaluation of individual studies needs

Overlooking the banks of the river Rhein, The Grand Hotel Trois Rois is one of the oldest hotels in Europe, famed for its art, architecture and cultural highlights. It is also believed that Napoleon Bonaparte was one of the hotel's first big-name guests.

The key to success in Risk Based Monitoring (RBM) is to incorporate a holistic evaluation of each individual study, not a one size fits all approach. Organisations that successfully implement RMB have the right organisational structure to support both central and on site monitoring; the analytics to review the data trends real time and the expertise to gain insight from data gleaned from sites.

A number of factors are leading to a paradigm shift in the way that clinical research is conducted. Regulatory agencies are demanding smarter, more efficient risk-based methodologies to improve the quality of data. The increasing cost of research and the adoption of EDC technologies that provide real-time access to data have forced the industry to look at optimised methods of conducting clinical studies. In addition, several studies have shown that 100% SDV may not result in higher data quality. Together, these factors have led to an increased interest in incorporating RBM strategies which were traditionally utilized in late phase and mega trials into a variety of study designs and phases. While much emphasis has been placed on the monitoring, the goal of an RBM approach is to better quality data.

Pioneers in RBM methodology, PRA team members have been utilizing RBM approaches for more than 20 years. Our RBM philosophy and strategy aligns with the regulatory/industry guidance’s (FDA, EMA, TransCelerate) and has a strong foundation in successful implementation. As a result, PRA has remained at the forefront of the RBM community, utilizing proven best practices for RBM within our own studies.

Who should attend;

- CEOs

- CMOs

- CSOs

- Heads of R&D

- Therapeutic Area Heads

- Clinical Trial Managers


For more information please contact Jenell Rogers on: Jenell.rogers@industryreview.com