THOUGHT LEADERSHIP

In recent years, efforts to streamline clinical research activities while improving subject safety and data integrity have included risk based monitoring (RBM). As recently as May 2019, the International Council for Harmonisation (ICH) proposed revisions to its General Considerations for Clinical Studies (E8) guideline. Section 3 of E8 (R1) stresses the importance of managing the quality of safety measures and data collection as part of an entire Quality Plan in a clinical program and its studies. This effort is called Risk-Based Quality Management (RBQM).

AICROS, the Association of International Clinical Research Organizations, is a consortium of small to mid-size CROs that collaborate to provide clinical research services to the biotechnology, pharmaceutical and device industries worldwide. PROMETRIKA joined AICROS in 2018 and on May 29 -30th, PROMETRIKA’s Head of Clinical Operations, Heather Paden, attended the AICROS Annual meeting, which took place in Kaunas, Lithuania.

PROMETRIKA Clinical Operations was recently faced with the challenge of initiating the first clinical trial for a specialized research group at a large, academic, world-renowned, oncology research hospital in the US.