Monthly Archives: October 2015

CluePoints Partners with OmniComm Systems® to Offer Collective Risk-Based Monitoring & Electronic Data Capture Solution

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Image 10-20-15

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. To find out more and register, visit http://lp.cluepoints.com/roadshow

For further information on CluePoints’ solutions, please visit www.cluepoints.com
For further information on OmniComm’s technologies and services, please visit http://www.omnicomm.com

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About CluePoints
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.

About OmniComm
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.

Media contacts
Patrick Hughes – Chief Commercial Officer, CluePoints
patrick.hughes@cluepoints.com
+44 (0) 7703 532 749
Dennis Constantinou, OmniComm Systems, Inc.
dconstantinou@omnicomm.com
+1.954.473.1254

CluePoints Announces Partnership with Bracket for CNS Trials

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Strategic partnership will bring together CluePoints’ Risk-Based Monitoring Software with Bracket’s Rater Training and Quality Assurance Services for CNS trials

6 October 2015

Cambridge, MA – CluePoints, a leading software provider of risk-based monitoring (RBM) solutions for clinical trials, today announced a partnership with Bracket Global, a leading provider of technologies and services that drive superior clinical outcome results. The exclusive partnership will see CluePoints’ RBM software offered in combination with Bracket’s Blinded Data Analytics and Rater Training and Quality Assurance oversight program for psychiatry and neurology trials. Bringing together CluePoints’ and Bracket’s expertise and solutions will enhance the impact of the services that each company delivers to sponsors, improving the integrity and quality of clinical data.

As the recognized leader in Rater Training and Quality Assurance, Bracket is an ideal partner to offer CluePoints’ Central Statistical Monitoring (CSM) solution that delivers an agnostic approach to RBM and Data Quality Oversight by using statistical methodology to identify unusual patterns in clinical trial databases. Bracket’s long track record of helping sponsors achieve better signal detection and develop clinical quality assurance programs, ideally aligns the company to promote the value of CluePoints’ software in detecting potential data quality problems in CNS trials.

“We are delighted to announce our partnership with CluePoints, a company which is leading the way in software that can support the practical implementation of RBM techniques in today’s trials”, comments David Daniel, Sr. Vice President & Chief Medical Officer, Bracket Global. “Integrating CluePoints software into Bracket’s Electronic Clinical Outcomes Assessment-based data quality monitoring programs provides a level of efficiency and sophistication in de-risking CNS studies that has not previously been possible.”

CluePoints’ CEO, Franҫois Torche, said: “CluePoints experience of de-risking over 50 studies using our unique CSM solution, along with Bracket’s world-leading expertise in delivering quality assurance systems, provides us with a unique opportunity to deliver combined services that achieve the most detailed insight into clinical data for sponsors. Working together we will support CNS trials in improving data quality and integrity using independent, objective statistical methodology.”

CluePoints and Bracket have been selected to present during the “Innovation Showcase” at the 2015 CNS Summit on October 9 in Boca Raton, Florida. Patrick Hughes, Chief Commercial Officer at CluePoints, will present “Integrating Central Statistical Monitoring in Clinical Quality Assurance Systems” to an annual gathering of drug development leaders from pharma, sites, and service companies.

For further information on CluePoints’ solutions, please visit www.cluepoints.com
For further information on Bracket’s technologies and services, please visit http://www.bracketglobal.com

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.

About Bracket
Bracket, with seven offices and more than 500 employees worldwide, is a Specialty Services provider dedicated to helping pharmaceutical sponsors and contract research organizations increase the power of their clinical research data by leveraging core competencies in Science, Technology, and Service. Bracket eCOA™ is a flexible platform for electronic Clinical Outcomes Assessments. Bracket RTSM™ is a best-in-breed, scalable and configurable Clinical IRT solution for the life sciences industry. Bracket Rater Training and Quality Assurance improves outcomes through customized training and quality assurance programs

Media contact
Patrick Hughes – Chief Commercial Officer, CluePoints
Patrick.Hughes@CluePoints.com
+44 (0) 7703 532 749