Maxims for Early Phase Trials

Discover the early phase clinical trial drug development fundamentals

This white paper considers the importance of conducting safe, efficient and productive early phase clinical trials and the options that are available to developers for study optimization.

What you'll find in our white paper

Over the last 40 years and thousands of early phase trials execution, SGS has acquired 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, this white paper covers the following Maxims – the early phase clinical trial drug development fundamentals:

1. Study design
2. Regulatory proofed
3. Modeling and simulation
4. Managing time and risk
5. Recruiting the studied population in a timely manner
6. Innovation powers research and development
7. Respect the rules of the protocol
8. Ensuring inspection readiness at clinical facilities
9. Meaningful data for conclusive FIH/Phase 1 trials
10. Bridging to patient clinical trials