July 1, 2025
While tech evangelists often tout artificial intelligence (AI) as healthcare’s silver bullet, the reality in clinical trials is more complex. Adoption has been cautious, shaped as much by concerns around trust and governance as by technical hurdles. Still, beneath the surface, methodical innovation is gaining momentum. AI is beginning to reshape how trials are designed,…
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June 16, 2025
It’s hard to believe that just five years ago, the clinical research industry found itself scrambling to adapt overnight. The COVID-19 pandemic ground global health systems to a halt and forced us all to move faster and more collaboratively than ever before. Read the full article by Allison Cuff Shimooka from The Medicine Maker here.
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June 13, 2025
Clinical research has never been more capable of reaching new frontiers. The science is here. The technology is here. But the approach to trial design and execution hasn’t kept pace. The clinical research ecosystem proceeds cautiously for good reasons—patient safety chief among them. But too often, we’re held back by fixed mindsets and outdated processes.…
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June 4, 2025
In ACRO and TransCelerate BioPharma’s latest collaboration, Cris McDavid (Senior Director, Global Clinical Operations, Parexel) and Tashan Mistree (Senior Director, Business Operations, Office of Chief Medical Officer, GSK) join this week’s episode to discuss the impact of ICH E6(R3) from their different vantage points in the clinical research industry. Listen to the podcast by Cris McDavid and Tashan Mistree…
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May 7, 2025
In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate…
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May 1, 2025
For decades, women were significantly underrepresented in clinical trials. Recent years have seen improvement, but there are lingering gaps in our collective understanding of how therapies work across sexes, life stages, health conditions and care settings. Read the full article by Jeneen Donadeo from PharmaTimes here.
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April 23, 2025
If you’ve begun combing through the new ICH GCP E6(R3) guidelines to understand how the updates will affect your clinical research practices and feel just a little lost or overwhelmed, you’ve got help. TransCelerate BioPharma, in a partnership with the Association of Clinical Research Organizations (ACRO), has designed and released 13 tools to support E6(R3) adoption across…
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April 7, 2025
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 University, and Chris Decker from CDISC, explored the complexities and opportunities…
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March 17, 2025
Every International Women’s Day invites reflection: Where have we made strides toward equity, and where do critical gaps remain? In clinical research, we see clear and sometimes sobering examples of how important these reflections can be. Until 1993, women weren’t even required to be included in U.S. clinical trials — an eye-opening fact that illustrates how recently…
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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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