THOUGHT LEADERSHIP

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.

Recently, while performing CDISC SDTM mapping for one of our clients, a unique situation arose that involved the DA (Drug Accountability) domain.  This domain tabulates the amount of treatment units dispensed to a subject and the amount returned to gauge dosing compliance for each treated subject and is often collected in a log format.  On the surface, it seems like a fairly straight forward domain, but for this particular example, there were a number of factors that contributed to creating a complex scenario.

PROMETRIKA, LLC. is a full-service CRO whose clients include national and international biopharmaceutical and medical device companies. In the clinical research environment, even “simple” studies become significant projects spanning multiple companies, teams, investigators, and regulatory bodies. Given such complexity, our Project Managers (PMs) are critical to effective management of all services and functions that contribute to the success of a project.

An important aspect of PROMETRIKA’s work as a full-service CRO for sponsors is the monitoring and reporting of safety-related events during clinical trials. Our sponsor colleagues focus on drugs and biologics addressing rare diseases and other conditions that so far have proven difficult to treat. PROMETRIKA’s Safety and Pharmacovigilance activities are focused on accurate and timely drug safety reporting.

An important aspect of PROMETRIKA’s work as a full-service CRO for sponsors is the monitoring and reporting of safety-related events during clinical trials. Our sponsor colleagues focus on drugs and biologics addressing rare diseases and other conditions that so far have proven difficult to treat. PROMETRIKA’s Safety and Pharmacovigilance activities are focused on accurate and timely drug safety reporting.