Citeline Finalist CluePoints Show Advanced AI Capabilities

March 22, 2023

Citeline Finalist CluePoints Show Advanced AI Capabilities

RBQM leader shortlisted as a finalist for Citeline Award accolade in The Best Use of Artificial Intelligence in Clinical Trials category

King of Prussia, PA  – March 23rd, 2023: CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Risk-Based Quality Management Software for clinical trials, has announced it has been shortlisted for the 2023 Citeline Awards in the Best Use of Artificial Intelligence in Clinical Trials category.

The award category recognizes companies, teams, or individuals leveraging artificial intelligence solutions to improve clinical trials or support successful clinical trial operations.

CluePoints has been shortlisted for its Root Cause Decision Support feature. This feature uses Natural Language Processing (NLP) and Deep Learning to help sponsors determine if risk signals flagged by the central monitoring platform are sufficiently documented ahead of regulatory submission.

Released in 2022, the Root Cause Decision Support solution has been built on CluePoints data from more than 127,000 risk signals generated using data from 1,065 studies conducted by 89 sponsors in all therapeutic areas since 2015. Since the release of Root Cause Decision Support, the solution has resulted in a 13.9% increase in clear risk signal documentation, providing confidence in inspection and submission readiness.

Patrick Hughes, Co-Founder and Chief Commercial Officer of CluePoints, commented, “It is an absolute honor to be shortlisted for this accolade and have CluePoints’ artificial intelligence solutions recognized by the Citeline Awards, especially as this is a new ‘Risk-Based Data Management’ product category for our organization.”

“This nomination is important for CluePoints as it highlights the developments that we have made with the use of artificial intelligence and machine learning in our operations over the last couple of years. Throughout 2023, we look forward to future advancements in artificial intelligence at CluePoints, using our deep learning knowledge to target improvements to traditional processes by removing inefficient manual tasks and allowing subject matter experts to concentrate their critical thinking on solving the problems that really matter.”

CluePoints has previously won the 2022 Citeline Award for Excellence in Innovation in Response to COVID-19 – Clinical Trial Activities.

For further information on CluePoints’ solutions, please visit


About CluePoints

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.