
May 1
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 to these guidelines.
Listen to the podcast by David Nickerson and Arlene Lee from Applied Clinical Trials here.
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…
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…
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…