THOUGHT LEADERSHIP

PROMETRIKA was one of the proud sponsors of the MassBio Rare Disease Day Forum in Boston. Several of PROMETRIKA’s team members from Clinical Operations, Biostatistics, and Project Management came away from the event with new insights and increased dedication to contributing in the rare disease space.

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.

The annual CDISC US Interchange conference is an opportunity for PROMETRIKA’s Statistical Programming team to learn about the newest ideas and trends for data dissemination in the industry. At this year’s gathering, between the keynote speaker’s sentiments, the FDA’s opening thoughts, and the breakout sessions – one idea carried through each talk; how do we increase communication and collaboration across all functions to make everyone’s life easier and reduce the work load placed on all involved – from Sponsors to CROs to the FDA to patients?

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.

As a Senior Medical Writer, I participated in the 2024 annual conference of the American Medical Writers Association (AMWA) to lead a roundtable on protocol QC and keep up to date on trends and best practices in documents related to clinical research. While many of the best attended sessions were related to the current and upcoming use of AI in the field of medical writing, there were plenty of sessions and workshops (as well as discussions during the protocol QC roundtable) that served as reminders that it is still the human aspect of projects that make the greatest impact in the timeliness and quality of a document or project.