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.

When I take a moment to reflect on what led me to be the person I am today, the road to success in all of my accomplishments began at Beacon Academy. I am a member of the founding class of 2006, and the profound impact Beacon Academy has is truly 14 months that last a lifetime.

Beacon Academy is more than just a school. It’s a 10-year program for students from historically under-resourced communities, catalyzed by a transformational “Beacon Year” between 8th and 9th grade. This gap year is designed to prepare highly motivated students to succeed in top-tier high schools, colleges, and ultimately, fulfilling careers. Beyond academics, Beacon supports its students with a variety of resources including financial assistance, college and career guidance, care packages, and a powerful alumni network. Their mission is rooted in advancing educational equity and closing the opportunity gap by making a long-term commitment and investment in its students.

Building a robust and efficient electronic data capture system (EDC) for today’s complex clinical trials is a major undertaking. The elements of the EDC must be carefully planned, the programming must be succinct, and the risks to data integrity must be considered. Clearly, these crucial requirements demand careful thought and can be time-consuming. An option for the timely initiation of a trial may be to split the release (a.k.a., the “go-live”) of EDC elements in a controlled and considered manner. PROMETRIKA’s Data Management team has extensive experience with planning and executing successful split-release EDCs.

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.