In this Q&A, Aman Khera, Global Head of Regulatory Strategy for Worldwide Clinical Trials, discusses her appointment to the board for The Organization of Professionals in Regulatory Affairs (TOPRA).
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The following blog outlines strategic decisions to consider at the feasibility stage of a proof-of-concept study.
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Aman Khera, Global Head of Regulatory Strategy, provides an assessment of the clinical research industry’s performance with respect to diversity and inclusion.
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Following part 1 of our series, this post provides valuable insights into the role of manufacturing and compounding, investigational drug blinding, dispensing, dosing, and the four areas where pharmacy procedure adherence is crucial to successful early phase clinical trial execution.
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The following blog discusses suggestions for integrating CPU pharmacy staff with Phase I clinical trial teams for streamlined processes and accelerated timelines.
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The following blog is a discussion of the contributing factors to the decision whether to use patient, normal healthy, or hybrid participant cohorts in Phase I clinical trials.
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