From ClinOps to Data Management: The Integrated Approach
The Association for Clinical Data Management (ACDM) recently asked Artem Andrianov, PhD, CEO and co-founder of Cyntegrity, about the evolution of Risk-Based Quality Management (RBQM).
Speaking at the 2nd Annual ACDM Symposium on RBQM, Artem highlighted how RBQM has evolved from supporting Clinical Operations to becoming an integrated approach to data management. By leveraging centralized monitoring, Central and Medical Monitors are the first to interact with objective, real-time data through RBQM dashboards, enabling a lean approach to identifying study and patient risks and initiating prompt action. As a secondary layer, Data Managers and Biostatisticians zoom in on anomalies and data requiring deeper investigation, ensuring efficient and thorough oversight of trial data.
Artem noted how the pandemic accelerated this shift as the industry adopted remote trial solutions. He used a compelling analogy: “Seeing the roadblocks ahead reduces the need for constant course correction,” emphasizing how RBQM equips teams with the foresight needed for smoother trial management.
The Future: Enabling Strategic Decision-Making with Data Intelligence
Cyntegrity is advancing its RBQM platform by integrating AI tools to simplify study protocols, reduce risk, and identify opportunities across clinical trials and portfolios. By positioning RBQM as a functional element within a broader data intelligence framework, Cyntegrity strives to help sponsors streamline processes, discover new opportunities, and make informed, data-driven decisions.
