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Over the last 30 years and thousands of early phase trials execution, SGS has acquired a unique expertise in early phase healthy subjects and patients clinical trials.

From drug development consultancy, preclinical data analysis, study design and first in human (FIH), to exploratory trials and proof of concept studies, we are pleased to share, through the following Maxims, the early phase clinical trial drug development fundamentals.

Early Phase Clinical Trials - Maxim #1

Maxim #1

Analyze all pre-clinical data and optimize the study design

The moment when a new compound is ready to be tested in humans is exciting but challenging. It means the drug has successfully passed a battery of pre-clinical tests, but based on these, many important decisions for its clinical development need to be made such as:

  • Safety conditions of the trial for the volunteers
  • Study feasibility
  • Biomarker choices

To predict a drug’s behavior in humans, all relevant pre-clinical data should be thoroughly analyzed. Often, more data is needed than what is strictly required by the regulators depending on the pharmacological and safety profile. For study design there is also not one-size-fits all.

To learn more about how to analyze all pre-clinical data, and optimize study design with concrete case studies.