What are Phase I clinical trials?

Phase I clinical trials are the first in-human testing of an investigational drug, primarily focused on safety, tolerability, and pharmacokinetics.

How long do Phase I trials last?

Typically, Phase I trials can last from a few months to over a year, depending on the study design and participant recruitment.

Who participates in Phase I trials?

Generally, Phase I trials involve healthy volunteers, although certain studies may include patients with specific conditions related to the drug being tested.

What is the role of the Clinical Research Associate?

Understanding the role of a Clinical Research Associate (CRA) is essential in managing clinical trials, ensuring compliance, and maintaining quality standards. For more information, visit our page on what is a clinical research associate.