Using Feasibility to Guide Indication Selection for Your Proof-of-Concept Clinical Trial
The following blog outlines strategic decisions to consider at the feasibility stage of a proof-of-concept study.
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Diversity and Inclusion: Four Things We Know for Sure, and Four We Have Yet to Learn
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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Phase I Clinical Trials: Why Strong Pharmacy Support of Early Phase Protocols Matters – Part 2
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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Phase I Clinical Trials: Why Strong Pharmacy Support of Early Phase Protocols Matters – Part 1
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 Phase I Choice: Patients, Normal Healthy Volunteers, or Both?
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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New Early Phase Strategies for Drug Development Success
The following blog is a discussion of the webinar “Clinical Pharmacology: Then & Now,” highlighting how new approaches in early phase clinical trials enable faster timelines and add value to investigative drugs.
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