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Grand Rounds August 18, 2023: Opportunities to Improve Clinical Trials: Draft Revision of the ICH Good Clinical Practice Guideline (E6R3) (Prof Sir Martin Landray, FMedSci; M. Khair ElZarrad, PhD, MPH)

Rethinking Clinical Trials

Food and Drug Administration (FDA) Slides Keywords Pragmatic trials; Research; Guidance, Regulatory, Data Governance Key Points The clinical trial enterprise needs modernization. COVID-19 made us think about things differently, because one couldn’t apply rules, one had to apply principles.

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Grand Rounds August 18, 2023: Opportunities to Improve Clinical Trials: Draft Revision of the ICH Good Clinical Practice Guideline (E6R3) (Prof Sir Martin Landray, FMedSci; M. Khair ElZarrad, PhD, MPH; Adrian F. Hernandez, MD, MHS)

Rethinking Clinical Trials

Food and Drug Administration (FDA) Slides Keywords Pragmatic trials; Research; Guidance, Regulatory, Data Governance Key Points The clinical trial enterprise needs modernization. COVID-19 made us think about things differently, because one couldn’t apply rules, one had to apply principles.

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eConsent: What it is and Why your eClinical Software Should Have it

Crucial Data Soutions

What’s the keyword in informed consent? Support from regulatory bodies, such as the FDA and Office for Human Research Protections (OHRP), continues to grow. We believe cost should never hinder research teams from using the technology tools that facilitate better clinical trials. Contact us today.