THOUGHT LEADERSHIP

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.

The 2025 New England Rare Disease Statistics (NERDS) workshop, held on October 9-10 in Boston, brought together leading biostatisticians, data scientists, clinical researchers, and regulatory professionals from academia and industry. This workshop served as an important forum for exchanging innovative ideas aimed at addressing the unique statistical and regulatory challenges inherent to rare disease drug research and development. At PROMETRIKA, we continue to advance collective expertise and strengthen our contributions to successful clinical development.

The PROMETRIKA team attended the Fierce Biotech Week conference, which offered a front row seat to the evolving landscape of clinical research, where innovation is not just a buzzword but a driving force. The conversations centered around the growing adoption of Risk-Based Quality Management (RBQM) and the ongoing evolution of the Trial Master File (TMF) as a critical tool for inspection readiness. These topics not only dominated sessions and panels, they sparked dynamic roundtable discussions, signaling a shift in how the industry is approaching trial efficiency, compliance and data integrity.

As the role of statisticians continues to change in a rapidly advancing digital landscape, adaptability and continued learning matter now more than ever. To this end, PROMETRIKA supports its team members in attending conferences where the most current methods and industry guidance are discussed. the annual American Statistical Association (ASA) Biopharmaceutical Section Regulatory-Industry Statistics Workshop in Rockville, MD,features representation from the pharmaceutical industry, academia, and the FDA. The most recent conference focused heavily on the evolving role of statisticians in the artificial intelligence (AI) and machine learning (ML) era. A consensus emerged regarding AI and ML, following innovative perspectives shared by several speakers. While both are viewed as powerful tools with great potential to more efficiently deliver life-saving therapies to patients, caution must be exercised in model implementation.