THOUGHT LEADERSHIP

Today, international trials make up the majority (~65% on clinicaltrials.gov) of ongoing clinical trials. For sponsors and patients, the globalization of drug development has shortened the time to commercialization in key markets and expanded the availability of important new treatments. But globalization comes with a number of challenges, not the least of which is mastering logistics across countries, regions, and time zones. PROMETRIKA has formed strategic partnerships with like-minded and similarly sized local CROs in over 80 countries on 5 continents. These relationships optimize the management of key logistic concerns such as time zone differences, supply chain consistency, language barriers, and ethical and cultural considerations.

SCOPE 2026 in Orlando this year felt like a pivotal moment for our industry. It wasn’t just about the latest technical innovations, it was about how we ground these innovations in the human experience.

My conference experience began at dawn with Sunrise Yoga: In Gratitude for Clinical Research Participants, organized by CISCRP. PROMETRIKA, was proud to sponsor an event that centers on the very people who make our work possible. Practicing yoga as the sun rose over Orlando was a “grounded” way to start the week– it reminded me that behind every data point is a human life. The calm did not last long, though, as the conference was packed, the exhibit hall vendors were hungry, and the energy was high.

Sponsors of global trials face many challenges. One of the most sensitive concerns is appropriate collection and handling of clinical data. Data managers face variation in data collection methods and clinical trial practices among the countries or regions participating in a global trial. PROMETRIKA’s successful approach to data integrity includes strong global oversight and advanced technology and processes.

Team members at PROMETRIKA are encouraged to stay abreast of scientific and regulatory advancements in biopharma by attending industry conferences. Earlier this year, I took this opportunity to attend the World Orphan Drug Congress 2025 in Boston. Some of the brightest minds in biotech, pharma, patient advocacy, and regulatory sciences met to discuss and brainstorm around one of healthcare’s most complex challenges: rare diseases. Urgency and innovation were highlighted through powerful keynote speeches, deeply personal fireside chats, and content rich panels focused on everything from patient identification to artificial intelligence in clinical care. I’d like to share some highlights from my experience and the sessions I joined.

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.