Setting the Stage: PHUSE US Connect 2024 Overview

The PHUSE US Connect 2024 conference, a premier event in the field of clinical trials and data management, brought together industry leaders to share insights and innovations. This blog post will explore the key takeaways from the conference, with a particular focus on the importance of data integrity, the role of AI/ML methodologies, and Cyntegrity’s vision for Quality by Design (QbD) and integrated Risk-Based Quality Management (RBQM).

Data Integrity in Clinical Trials: A Shared Vision

At the conference, a unique partnership between Bristol Myers Squibb and Cyntegrity highlighted the critical role of data integrity in clinical trials. Michael Walega, Head of Centralized Monitoring at Bristol Myers Squibb, and Dr. Johann Proeve, Chief Scientific Officer at Cyntegrity, discussed how an integrated RBQM solution can help detect and prevent fraud and misconduct, ensuring the reliability and validity of trial data.

The Role of AI/ML in Clinical Trials

The PHUSE/FDA Innovation Challenge centered on the Application of AI/ML Methodologies. The conference featured presentations and discussions on the use of AI and machine learning in risk-based monitoring and clinical trial developments. Cyntegrity, aligning with this theme, sees great potential in the use of AI in protocol design and prediction models for adverse events.

Patient Involvement and Open Source Initiatives

The conference also emphasized the need for more patient involvement in defining their needs and personalizing their experience through the inclusion of eCOA/ePRO data. This aligns with Cyntegrity’s patient-centric approach in clinical trials. Additionally, the growing popularity of open source initiatives, which Cyntegrity supports (interactive data visualizers), was a notable highlight.

Balancing AI Innovation with Practicality

While AI and machine learning hold great promise for the future of clinical trials, the conference also highlighted some of the challenges associated with their use. Cyntegrity shares this perspective, advocating for responsible implementation, focusing on customer needs, and avoiding unnecessary complexity. We believe that AI innovation should support QbD principles and integrated RBQM to augment lean and effective GCP compliant workflows.

Recognition for Exceptional Contributions

The conference concluded with the Best of Stream recognition, awarded to Dr. Johann Proeve and Michael Walega for their insightful presentation, “My Data Are Too Good to Be True! Should I Worry About Fraud or Sloppiness?” This recognition underscores Cyntegrity’s commitment to driving clinical data science forward.


The PHUSE US Connect 2024 conference provided valuable insights into the future of clinical trials. These insights, along with Cyntegrity’s vision for QbD and integrated RBQM, will play a crucial role in shaping the future of clinical trials and ensuring the reliability and validity of trial data.

For more details on the conference and the presentations, please visit the PHUSE website: PHUSE US Connect 2024

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