Monday, August 11, 2014

CluePoints Survey Reveals that Determining the Best Approach is the Industry's Biggest Challenge to Implementing a Risk-Based Monitoring Strategy

A survey by CluePoints, Partnerships in Clinical Trials sponsors and a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, has revealed that 42% of respondents from across the industry consider agreeing the best and most practical approach to be the biggest challenge their organizations are facing 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 are currently 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", comments FranÒ«ois Torche, CEO of CluePoints. "Our CSM solutions have been developed to make implementing adaptive monitoring as straightforward as possible and simplify the transition for users. The new findings give insight into the needs of the industry and we are currently working with a wide range of sponsors and CROs to demonstrate how these new solutions can be pragmatically and straightforwardly included in their research designs."

The survey was conducted online as part of CluePoints' most recent addition to its 2014 webinar series, entitled 'Risk-Based Monitoring – What we’ve learnt in a year, a Large Pharma Perspective from Sanofi'. Download the webinar here.

For further information on CluePoints' solutions, please visit

About CluePoints
CluePoints® is a Central Statistical Monitoring solution that has been designed and perfected over the last 10 years. It employs unique statistical algorithms to determine the quality, accuracy and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the FDA and EMA, CluePoints® is deployed to support traditional on-site monitoring and to drive a risk-based monitoring strategy. The value of using CluePoints® lies in its powerful and timely ability to identify anomalous data and site errors allowing improvement in clinical data quality, optimization of on-site monitoring and a significant reduction in overall regulatory submission risk.

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