Whitepaper: Risk-Based Monitoring for Late Phase Research

The growing consensus among clinical researchers and regulatory authorities is that risk-based monitoring (RBM) is more likely to ensure patient protection
and overall study quality, and allows for monitoring that can be more effective than the traditional model of routine visits to all sites with 100% source data
verification (SDV).

A number of factors are leading to the paradigm shift in the way that clinical
research is conducted. 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 optimized methods of conducting clinical studies. In addition, several
studies have shown that 100% SDV may not result in higher data quality. All of these factors have led to increased interest in RBM strategies.
 

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