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Clinical Research Resources Office (CRRO), CTSI, Boston University School of Medicine

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What Experts Are Saying About RWD in Clinical Trials

Clinical Research Resources Office (CRRO), CTSI, Boston University School of Medicine At the 2025 SCOPE Summit Conference, industry leaders gathered to discuss the integration of real-world data (RWD) into clinical trials and practice. The panel, featuring Robert DiCicco from TransCelerate Biopharma, Su Chen from MITRE Corp, Jesper Kjaer from Novo Nordisk, Trevan Locke from Duke…

SCOPE Summit 2025: Fast Forward to 2035: What Success Could Look Like in Converging Clinical Research and Care—And How to Get There

Clinical Research Resources Office (CRRO), CTSI, Boston University School of Medicine This year’s SCOPE conference in Orlando kicked off with a keynote address from Janice Chang, CEO, TransCelerate Biopharma, and Mark McClellan, MD, PhD, director, Duke-Margolis Institute for Health Policy, Former Commissioner, FDA. Titled “Fast Forward to 2035: What Success Could Look Like in Converging…

A New Era in Advancing Care for Pregnant and Breastfeeding Patients

Clinical Research Resources Office (CRRO), CTSI, Boston University School of Medicine One major challenge facing the clinical research ecosystem is not whether, but how to study drug safety and efficacy in pregnant and breastfeeding populations. A growing number of organizations—including the ICH E21 Expert Working Group (EWG) and TransCelerate’s Interpretation of Pharmacovigilance Guidances & Regulations  (IGR…