Strategic collaboration enables customers to harness the value of data capture coupled with data quality oversight
20 October 2015
Cambridge, MA – CluePoints, a leading software provider of risk-based monitoring (RBM) solutions for clinical trials, today announced a partnership with leading eClinical solutions provider, OmniComm Systems (OmniComm). Under the partnership, the two companies will work together to deliver OmniComm’s electronic data capture (EDC) technology and services integrated with CluePoints’ RBM software, offering customers a best-in-class solution that couples data collection with complete oversight of data quality.
Meeting the challenges of clinical data oversight in the age of more complex and global clinical trials is increasingly difficult for sponsors. OmniComm’s outcomes orientated EDC solutions enhance data quality while reducing query rates. By bringing its solutions together with CluePoints’ Central Statistical Monitoring (CSM) solution, which supports robust statistically driven RBM and quality assurance strategies, the two companies can offer customers a sophisticated way of collectively embedding data capture, analysis and visualization into their processes in a single step.
Steve Young, senior director of transformation services at OmniComm, comments, “We are delighted to partner with CluePoints. As a provider of leading edge EDC and RBM enablement technology and services, integrating their powerful RBM software with TrialMaster® EDC technology and our RBM enablement services helps us advance the use of our systems outside the periscope of data capture. Together we can provide an answer to the challenging questions of clinical data oversight, streamlining processes and helping our customers to improve their outcomes.”
CluePoints’ CEO, Franҫois Torche, said, “Collectively our customers are looking to harness the value of EDC technology coupled with analytics for RBM and data quality oversight. The integration of our services and solutions will mean that they can get the best out of both systems, providing them with reassurance that they are achieving the highest quality data possible.”
CluePoints and OmniComm will together present ‘The RBM Roadshow’, a special thought leadership event discussing the benefits derived from an integrated solution for EDC technology, targeted source data verification (SDV), and centralized analytics/key risk indicators (KRIs). The events will take place in Cambridge, MA on November 4th, Chicago on November 9th and San Francisco on November 10th, 2015.
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CluePoints® is a Central Statistical Monitoring solution that has been designed and perfected over the last 12 years and is available to companies as cloud-based software to drive Risk-Based Monitoring (RBM) and Data Quality Oversight. 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.
OmniComm Systems, Inc. is a leading strategic software solutions provider to the life sciences industry. OmniComm is dedicated to helping the world’s pharmaceutical, biotechnology, contract research organizations, diagnostic and device firms, and academic medical centers maximize the value of their clinical research investments. Through the use of innovative and progressive technologies these organizations drive efficiency in clinical development, better manage their risks, ensure regulatory compliance and manage their clinical operations performance. OmniComm provides comprehensive solutions for clinical research with an extensive global experience from over 4,000 clinical trials.