THOUGHT LEADERSHIP

More than 64% of the trials posted on clinicaltrials.gov include at least one country outside of North America. For American-based sponsors, expanding trials outside the scope of North American regulators raises concerns around regulatory compliance, logistical methods, and participant wellbeing. Overarching all of these challenges is the question of how well international trials can be managed. PROMETRIKA has developed a management model to ensure informed and efficient communication and activities during global trials.

Throughout the 17 years that PROMETRIKA has offered Clinical Operations services, our goals have been to streamline and maximize efficiency in clinical trials and provide trial management transparency to our sponsors. We have steadily enhanced and integrated our trial data collection and management systems to achieve a fully integrated platform that will provide seamless coordination of EDC, CTMS, and eTMF data.

Data Management (DM) and Clinical Operational teams must work hand in hand to properly execute the capture, management, and monitoring of clinical data throughout the entire life cycle of a study; however, the use of different systems, processes, and datasets makes close and effective collaboration a challenge.

“PROMETRIKA invites you to read and enjoy a two-part blog series on risk-based monitoring (RBM) and the different clinical trial monitoring approaches based on our clinical operations team’s experience and research objectives.  We will explore the differences between the traditional 100% source document verification (SDV) approach and RBM through the lens of two hypothetical clinical research associates (CRAs) as told in the style of an afternoon soap opera.”

“PROMETRIKA invites you to read and enjoy a two-part blog series on risk-based monitoring (RBM) and the different clinical trial monitoring approaches based on our clinical operations team’s experience and research objectives.  We will explore the differences between the traditional 100% source document verification (SDV) approach and RBM through the lens of two hypothetical clinical research associates (CRAs) as told in the style of an afternoon soap opera.”