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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.
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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.
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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.
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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.
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Home visits as part of clinical research have accelerated in recent years as we strive to find the right balance between facilitating study participation while accommodating participant’s busy everyday lives. Clinical trials in rare diseases are even more challenging than trials in other diseases due to a number of factors:
- Small number of eligible trial participants
- Complicated by heterogeneity among rare disease patients
- Most have no cure and manifest at a young age
- Less than 10% of rare diseases have a specific treatment
- Many have other debilitating conditions / physical limitations making it difficult to attend frequent study visits
The combination of home study visits and the right technology removes barriers to optimal patient recruitment, compliance and retention.
THOUGHT LEADERSHIP
