THOUGHT LEADERSHIP

The importance of keeping an inspection-ready electronic trial master file (eTMF) at all times cannot be understated; the TMF tells the story of the clinical trial and should serve as the ultimate source of truth for the study. An inspection-ready TMF is complete without being redundant and efficient while still upholding high standards of quality. This might sound like a lot of work, but don’t let it intimidate you; an inspection-ready TMF can be achieved by following the steps outlined below.

Attending the 2025 Muscular Dystrophy Association (MDA) Clinical and Scientific Conference was more than just a professional checkpoint; it was a much-needed reminder of why we do what we do. I am a Sr. Clinical Trial Manager at PROMETRIKA, a full-service CRO based in Cambridge, MA. Every day, I am engaged in the meaningful work of advancing treatments for patients across many therapeutic areas.

The globalization of drug development has shortened the time to commercialization in key markets and expanded the availability of important new treatments. Before the ability to efficiently conduct a global clinical trial, separate region-specific trials were required in a number of major markets. Recent advances in technology, and collaborations among regulatory agencies, have shortened the time to gathering the data necessary for multi-region approvals. But globalization comes with a number of challenges that may be daunting for small and emerging biopharma companies. For these sponsors, there are advantages to partnering with a small global CRO. Here, we will look at PROMETRIKA’s solution to meeting the diverse regulatory requirements presented by global trials.

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.