May 6
TransCelerate Member shares their experience and best practices for the Clinical Study Report (CSR) and Lean Writing Principles
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Unifying Industry to Better Understand GCP Guidance
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…
Closing the Evidence Gap in Women’s Health – the Need for Inclusive Clinical Research
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.
Unsure About The New ICH Guidelines? TransCelerate Debuts 13 Tools To Help
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…