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September 21, 2021  •  Blog

Human Challenge Studies for Vaccine Development: Regulatory Aspects of Human Challenge Studies

Introduction The traditional regulatory pathway for the evaluation of new vaccine candidates generally proceeds from preclinical through three successive phases of human trials. Study phases may overlap, and the clinical testing may be highly iterative because multiple Phase 1 or 2 trials may need to…

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February 23, 2021  •  Blog

Tips on Using ClinicalTrials.gov to Align Your Product Clinical Trial Designs with FDA expectations

One of the Clinical areas in which we at Biologics Consulting are asked to consult involves assisting a company that is planning clinical trials for their product and wishes to do so with minimal risk of failure. In the oncology clinical development space especially, the pace of change can result in…

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September 25, 2020  •  Blog

AstraZeneca’s Trial Is on Hold. It’s a Sign that the Science Is Working

Everyone awaiting a vaccine against Covid-19 must understand this fact: Bad outcomes may happen in vaccine trials. The good news is the U.S. Food and Drug Administration evaluates these outcomes before approving a vaccine. The purpose of clinical trials is to discover what can go wrong with a vaccine…

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