THOUGHT LEADERSHIP

January marks the time to develop goals for the upcoming year, and for 2023, I wanted to create a goal outside of project work and pursue individual career development. I became aware of the Certified Clinical Data Manager (CCDM®) program/exam.

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.

In a CRO environment, managing Data Management programming requests presents significant challenges, including prioritization, resource planning, and timely delivery of results. There are a set of recurring tasks, coming from multiple sponsors, with varying frequencies and updates needed. Programmers need a way to keep these tasks organized and to optimize the work flow.

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.