King of Prussia, PA – December 5, 2019: CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Risk-Based Quality Management Software for clinical trials, today announced that it has been awarded best technological development in clinical trials in the 2019 Scrip Awards. CluePoints’ Risk-Based Study Execution (RBx) and Risk-Based Quality Management Software was recognized for the essential role it plays in improving clinical trials. The solution can help drive the quality, accuracy, and integrity of clinical trial data both during and after study conduct, improving patient safety and increasing productivity, efficiency and cost-effectiveness.
CluePoints’ vision of RBx, where independent data interrogation, comprehensive analysis, and resulting actions become reusable knowledge, has captured the imagination of the industry. With the evolution of Risk-Based Monitoring and regulatory requirements, combined with sponsor demands for cost-effective solutions that leverage technology and provide improved data quality, real-time Central Statistical Monitoring (CSM) is a “must-have” service.
Commenting on the win, Patrick Hughes, Chief Commercial Officer of CluePoints said,“CluePoints® has been a pioneer in the field of Risk-Based Monitoring over the last 7 years; we continually enhance our Risk-Based Quality Management Solution to ensure that it remains both disruptive and relevant in today’s ever-changing clinical trial space. For the industry to acknowledge the value that CluePoints offers to sponsors, CROs and Clinical Technology Partners is an honor. We’re thrilled to be recognized for our proactive innovation, quality management vision and transparent approach, which are central to our success.”
There are several factors driving the need for RBx, including regulatory changes that have impacted the industry, forcing organizations to re-examine the mechanisms for maximizing clinical trial data quality and how organizations are structuring themselves is changing. In response, CluePoints is committed to helping companies identify, assess, plan, mitigate, monitor and analyze risk across all elements of clinical trial management to comply with regulatory requirements.
“For the CluePoints’ family, staff, customers and stakeholders, this accolade is the icing on the cake, following global expansion and further award wins,” continued Patrick Hughes. “The new software release demonstrates CluePoints’ ongoing commitment to continuously evolve its platform and add in features requested by its ever-expanding user base. Further, the solution’s continued ability to pinpoint areas of risk isn’t just enabling a more efficient process for Pharma companies and CROs, it is also ensuring better patient safety throughout the study as areas of concern are identified much earlier than previously capable using traditional processes.”
CluePoints continues to drive the paradigm shift towards an entirely different Risk-Based Approach to Study Execution (RBx) from pre-study risk assessment, through risk identification and control to final auditable documentation. All elements of trial management can be performed using a risk-based approach, aligned with ICH E6 (R2) and other key industry guidelines. By fully embracing a risk-based culture, proactive risk-management supports evidence-based decision making, guards patient safety and ensures the highest quality data.
For further information on CluePoints’ solutions, please visit www.cluepoints.com
CluePoints is the premier provider of Risk-Based Study Execution (RBx) and Data Quality Oversight Software. Our products utilize comprehensive 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, EMA, and ICH E6 (R2), CluePoints® is deployed to support central and on-site monitoring, medical review, quality risk management and to drive a holistic Risk-Based strategy in all trials. Coupled with thought leadership and consulting expertise to aid pre-study risk assessment, identification of risk controls and solution implementation, you now have everything you need to adhere with global regulatory guidance. The result is increased operational efficiency, lower costs and reduced regulatory submission risk as part of the industry paradigm shift to RBx.
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Patrick Hughes – Chief Commercial Officer, CluePoints
+44 (0) 7703 532 749