Monthly Archives

March 2016

Risk-Based Monitoring Implementation Survey: The Results

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1: Where do you see KRIs and DQO playing the greatest role?

As an operational driver for Risk-Based Monitoring


As a tool to ensure third party quality oversight


For overall Data Quality Oversight in late phase studies


As a stamp of data quality


As an insurance policy for clinical studies


2: How far along is your company in using RBM?

Bought into RBM and planning how to use it in most studies


Still evaluating the various approaches


Fully embraced RBM and using it in most late phase studies


Have piloted RBM in less than 5 studies


Currently conducting an assessment of vendors


CluePoints Named Clinical Research & Excellence Awards Finalist

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Awards recognize CluePoints’ Risk-Based Monitoring solution in the ‘Best Sponsor-Focused Technological Development’ category

Cambridge, MA – CluePoints, a leading software provider of Risk-Based Monitoring (RBM) solutions for clinical trials, has been named a finalist in the ‘Best Sponsor-Focused Technological Development’ category for the 2016 Clinical Research & Excellence (CARE) Awards. The company’s SaaS Central Statistical Monitoring solution for RBM and data quality oversight has been shortlisted for the inaugural awards which take place in Boston on 27 April 2016.

The CARE Awards provides the industry with an opportunity to acknowledge and applaud its highest achievers across all parts of the value chain, and to recognize both corporate and individual achievement. CluePoints software has been implemented by leading pharmaceutical companies and CROs as the engine to drive RBM, providing broad risk mitigation and patient safety through complete data quality oversight. The value of the solution lies in its ability to identify anomalous patient data and site discrepancies allowing improvement in clinical data quality, optimization of on-site monitoring and a significant reduction in overall regulatory submission risk.

“Our customers rely on us to deliver solutions that put them in complete control of their centralized monitoring and data quality oversight. As a result, users now have the ability to independently and objectively identify anomalies in data earlier, offering the opportunity to eradicate issues as they are uncovered”, commented  Patrick Hughes, Chief Commercial Officer, CluePoints. “The CARE Awards recognition of our software supports our continued efforts, and that of our customers and partners, to advance RBM and we are honored that our technology has been acknowledged among the best solutions in the industry.”

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.

Media contact:

Patrick Hughes – Chief Commercial Officer, CluePoints
+44 (0) 7703 532 749