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Explains the IND as the sponsor's regulatory application with preclinical animal studies, pharmacology, toxicology, and manufacturing data, guiding phase 1–3 trials toward NDA marketing approval.
This program will help participants to learn Clinical Trial Process/ Clinical Operations. Program starts with an Introduction followed by Phases in Clinical Trial Process, ICH- GCP guidelines, Stakeholders in Clinical Research and their responsibilities in Clinical Trial. Program gives and overview rather an in-depth details. If you are looking to get first hand information about clinical research, this program can be the right fit.