CluePoints, the premier provider of risk-based quality management (RBQM) and data oversight software for clinical trials, has partnered with ZS, a global professional services firm with technology and analytics expertise in biopharma, to offer innovative capabilities in portfolio-level performance oversight.
The new partnership pairs a best-in-breed solutions company focused on study-level risk-based management with a pharmaceutical and biotech solutions provider with advanced capabilities in portfolio-level quality and operational oversight.
“The value to the industry from this collaboration is extensive. CluePoints is in the business of building technology to increase efficiency and patient safety with improved data quality, while ZS’s innovative ‘control tower’ methodology offers a portfolio-level management tool to oversee quality across studies, processes and providers,” commented Patrick Hughes, co-founder and chief commercial officer of CluePoints.
“ZS’s work encompasses process, training, quality and study analytics to provide an executive-level summary that acts as a vital temperature check and an early warning system to identify trends and potential risks,” Hughes said. “We have already been aggregating risk data, signal data and action data across the portfolio of studies that we are supporting. This partnership means we can now offer oversight of each study’s process and vendors, in addition to our Risk-Based Monitoring analysis and artificial intelligence (AI) and machine learning techniques.”
The partnership also brings a new degree of expertise to the industry, now that both companies can draw on greater resources and offer consulting from a wider pool of subject matter experts. It sets the foundation to lead to new technology innovations that could further increase the value of risk-based approaches.
“As we are scaling as a knowledge company and continuing to enhance the value of this enabling technology, our community is asking for our help to improve the process for them. We’ve listened—this new partnership greatly extends our ability to solve increasingly complex problems with bespoke solutions,” he added.
Jonathan Rowe Ph.D., head of R&D Quality and Risk Management at ZS stated, “The capabilities of CluePoints, from protocol risk assessment tools to industry-leading RBM technology, fully complements the ZS capabilities in study design optimization, feasibility optimization and enterprise quality, and operational risk management across the portfolio, processes and vendors. This collaboration will deliver optimized risk management solutions for trial sponsors, bringing medicines to market faster with optimal quality.”
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.
ZS is a professional services firm that works side by side with companies to help develop and deliver products that drive customer value and company results. We leverage our deep industry expertise, leading-edge analytics, technology and strategy to create solutions that work in the real world. With more than 37 years of experience and 9,000-plus ZSers in more than 25 offices worldwide, we are passionately committed to helping companies and their customers thrive.