March 7, 2025
Clinical trials that support the development of new and innovative therapies and healthcare delivery are fundamentally supported by separate infrastructures, processes, and objectives. This comes with unique sets of capabilities, staffing, regulations, data platform systems, and incentives. But patients could be better served by a future that breaks with the status quo and unlocks the…
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March 4, 2025
The 2025 SCOPE Summit brought together industry leaders to explore integrating real-world data into clinical trials, focusing on pragmatic trials as a transformative approach. Key discussions revolved around regulatory initiatives, innovative trial designs, and operational strategies to enhance the applicability of clinical research in real-world settings. The summit highlighted the potential of pragmatic trials to bridge the…
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February 25, 2025
A panel of experts from inside several major pharma companies discussed regulatory initiatives around pragmatic trials in depth at the recent Summit for Clinical Trial Ops Executives (SCOPE). “I got a fever and the only prescription is more pragmatic trials,” quipped Henry Wei, M.D., head of development innovation at Regeneron and a major fan of TransCelerate’s…
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February 5, 2025
The growing convergence between clinical research and clinical care—and ways the second Trump administration will be encouraging and supporting movement in that direction—was the topic of the opening keynote presentation made at this week’s Summit for Clinical Ops Executives (SCOPE) in Orlando. It was presented as an informal but informative dialogue between Janice Chang, CEO of TransCelerate…
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February 3, 2025
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 Clinical Research and Care—And How to Get There”, the duo discussed…
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December 9, 2024
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 PV) initiative—are diligently seeking ethical and responsible solutions to protect these…
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October 10, 2024
The scientific community intended to protect pregnant and breastfeeding populations when it strictly limited their involvement in clinical trials after the thalidomide crisis of the 1950s-1960s. Yet over the past few decades, people have increasingly recognized the real-life challenges posed by the lack of research into the safety of medications used during pregnancy and breastfeeding.…
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August 16, 2024
Patient safety depends partly on sponsor organizations’ compliance with pharmacovigilance (PV) regulatory requirements—even when global variations exist. Helping sponsors interpret and operationalize challenging PV regulations and guidances is the goal of TransCelerate’s Interpretation of Pharmacovigilance Guidances & Regulations (IGR PV) initiative. In this third installment of our IGR PV blog series, we will examine the solutions…
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June 26, 2024
History converged with the future at DIA’s 60th-anniversary Global Annual Meeting. The conference’s theme—Charting New Horizons—fit the mood perfectly. The palpable energy and high attendance levels were reminiscent of pre-pandemic times; it felt like we finally put COVID-19 behind us. Still, underlying this return to “normal” was an eagerness not to forget the lessons of…
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June 20, 2024
Diversity, Equity, and Inclusion (DE&I) and drug safety in clinical trials teams may not have established relationships within an organization. Yet, these two areas of focus have more similarities than one might think. In our next installment of our series on our Interpretation of Pharmacovigilance Guidances and Regulations Initiative (IGR PV), we are exploring this…
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