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APPROPRIATE AND RELIABLE DATA FOR CONCLUSIVE FIH/PHASE 1 TRIALS 
Early Phase Clinical Trial "MAXIMS"
Clinical trials are intended to find answers to a research question by generating data to prove or disprove a hypothesis.
First-in-Human (FIH) and most Phase 1 trials by their very nature are exploratory, without a statistical hypothesis. They are aimed at obtaining reliable information on the safety, tolerability, pharmacokinetics and mechanism of action of a drug.

Discover the four main steps in clinical data processing:
  • Data Planning: study Protocol, (e)CRF
  • Data Collection: study Protocol/Manuals
  • Data Management: Data Management and Review Plan
  • Data Analysis: statistical/PK Analysis Plan, MOCK TLFs
To learn more about early phase clinical trial appropriate and reliable data with concrete examples.
 
 
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