Press Release

CluePoints Shortlisted for Multiple Awards in Recognition of Pioneering Risk-Based Quality Management Solution

King of Prussia, PA: 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 three international awards.

CluePoints, BioNTech, and Pfizer’s Phase I/II/III study of SARS-COV-2 RNA vaccine BNT162b2 (Comirnaty) has been selected as a finalist for the Clinical Advance of the Year – COVID-19 Pandemic Special Recognition Award at the Scrip Awards.

The company is also in the running for two Citeline Awards: ´Best Sponsor-facing Technology Initiative´ for their business intelligence platform, BEYOND. As well as ´Excellence in Innovation in Response to COVID-19 – Clinical Trial Activities´, for its work with Pfizer / BioNTech.

Commenting on the nominations, Patrick Hughes, Co-Founder and Chief Commercial Officer of CluePoints, said: “We are delighted to be shortlisted in recognition of our pioneering work in the fields of Risk-Based Quality Management (RBQM) and Data Quality Oversight.

Pivotal trials to test the COVID-19 vaccine required the processing and analysis of huge volumes of data from tens of thousands of patients across global clinical trial sites. By employing an agile RBQM approach, study teams were able to make decisions based on data in real-time to closely monitor anomalies and discrepancies, meaning drug applications were submitted in record time, with unprecedented levels of quality.

These studies represent a leap forward in how clinical trials can and should be conducted. The RBQM methodology employed is the blueprint for the future. We are honored to share these nominations with our valued partners and colleagues at Pfizer.”

Hughes added: “In addition, we are thrilled that BEYOND, our Business Intelligence platform for clinical trials, that provides powerful data analytics and visualizations of study data, has been shortlisted for Best Sponsor-facing Technology Initiative. This module within the wider RBQM platform facilitates a deeper understanding of what is happening within a clinical trial and further allows timely intervention to eradicate risk.

Study teams can focus on a specific area of the clinical trial, such as the safety profile and the status of adverse and serious adverse events, for example, as well as take a wider focus on clinical data across sites and studies.”

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.

CluePoints previously took home the award for best technological development in clinical trials in the 2019 Scrip Awards.

For further information on CluePoints’ solutions, please visit

About CluePoints

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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