Risk-Based Quality Management: A front row seat to a decade of transformation
King of Prussia, PA – October 12th, 2022: Risk-based quality management (RBQM) solutions provider, CluePoints, is marking its tenth anniversary this year – placing it at the center of the journey from fledging concept to a fully realized, evidence-based methodology.
The organization was just a year old when the US Food and Drug Administration (FDA) first recommended using risk-based monitoring (RBM) in 2013. The International Conference on Harmonization’s Good Clinical Practice (ICH-GCP) guidelines made the approach mandatory in 2016. Later this year, updated ICH guidelines are widely expected to mandate RBQM, which applies the principles of RBM to all elements of trial conduct for all clinical trials.
The two-hundred-strong team at CluePoints is proud to have been an integral part of this transformation, having worked closely with sponsors and regulators to build the tools and use cases needed to demonstrate the value of RBQM over the last decade. It is rare for sponsors to be able to increase efficiencies across various functional areas as a result of new regulations, but the insistence on a risk-based approach to clinical trial management does precisely that, and we now have the evidence to prove it.
However, there is still much work to be done in harnessing the full power of RBQM across the industry and combining it with technologies such as machine learning, deep learning, and artificial intelligence to improve the efficiency of clinical research further.
Patrick Hughes, one of the Co-Founders at CluePoints, stated: “Over the last decade, RBM and RBQM have evolved significantly. When we first started, sponsors were still married to the idea of traditional approaches, such as source data verification (SDV) and very manual data interrogation techniques, despite knowing they were inefficient. Now, more and more organizations agree that data-driven RBQM is the future of clinical research. In addition, with each iteration of ICH regulations, there has been a greater insistence that sponsors should take a risk-based approach to clinical trials. We think that will be even more pronounced in the expected R3 update this year.”
“The next ten years promise to be just as exciting for the industry. With the increasing popularity of decentralized clinical trials and alternative data sources, such as wearables, the volume of data being collected and in need of interrogation and oversight is set to explode. Integrating techniques such as deep learning, artificial intelligence, and natural language processing into RBQM will be invaluable in helping researchers to extract all valuable insights while still protecting patient safety and data quality.”
“The whole team at CluePoints and its valued customers and partners cannot wait to be part of the next decade of progress. The best is yet to come!”
Patrick Hughes is available for an interview on the evolution and the future of RBQM in clinical research. For more details, contact [email protected].
CluePoints is the premier Risk-Based Quality Management (RBQM) and Data Quality Oversight Software provider. 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 RBQM.