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CluePoints: Determining best approach is industry’s biggest challenge to implementing risk-based monitoring

Wednesday, August 6, 2014

A survey by CluePoints, a provider of centralized statistical monitoring (CSM) solutions for clinical trials, has revealed 42% of respondents across the industry say agreeing to the best and most practical approach is the biggest challenge their organizations face in implementing an effective Risk-Based Monitoring (RBM) strategy.

While two years ago RBM was not at the top of many minds, today 36% of the 520 survey respondents currently are in the process of evaluating practices, calling for greater awareness of how sponsors and CROs can develop and integrate the approach at a realistic and practical level.

The new survey was developed to gain an understanding of the industry’s insights into RBM and how changes to monitoring strategies are being managed at sponsor and CRO level. The research looked at the techniques that are currently available to the market with 59% of those surveyed pointing to the use of Central Statistical Monitoring as contributing major advantages from a usability perspective due to its ability to detect data accuracy and issues earlier, while requiring minimal work from study teams in gaining objective information.

“We carried out this survey to identify how people are managing making RBM a reality in their organizations and what is important to them at the moment. The survey findings have shown that the wealth of information that has been made available to the industry surrounding RBM over recent months has not armed decision makers with a clear understanding of how approaches can be practically implemented,” said Franҫois Torche, CEO of CluePoints.

The survey was conducted online as part of CluePoints’ most recent addition to its 2014 webinar series. CluePoints employs unique statistical algorithms to determine the quality, accuracy and integrity of clinical trial data both during and after study conduct. CluePoints supports traditional on-site monitoring and drives an RBM strategy.

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