THOUGHT LEADERSHIP

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.”

So, your organization has made the decision to transition to a new eTMF system. Congratulations on taking this step! Depending on your organization and your role, you may or may not have been part of the decision-making process for choosing the system. You may be somewhat familiar with the system or encountering it for the first time. Either way, now that the ink on the contract is dry, it is time to begin making the most of your new eTMF.