Clinical development is the phase in which a drug or biologic goes from a promising molecule to a product with sufficient evidence of safety and efficacy to reach the patient. It is also the phase of greatest cost, risk and regulatory demand.

This 16-hour Professional Certificate Course introduces ICH GCP E6(R3) as the standard of ethical and scientific conduct, human-subject protection under 21 CFR Parts 50 and 56 (IRB), and the design of Phase I (first-in-human, dose escalation, PK) and Phase II (proof-of-concept, dose-finding) trials.

The Introductory course prepares participants for the Advanced level (RAQ-645-A), where Phase III and IV, adaptive designs and master protocols, and vulnerable-population and global-trial considerations are developed in depth.

The Introductory course gives clinical-research, regulatory and quality professionals the GCP and human-subject-protection foundation on which every clinical trial and IND depends.

Participants who meet the course completion requirements receive a Certificate of Completion issued by Aleph University.