- Overview
- Agenda
- Features
- Justify This Training
- FAQ
Watch Trailer
Agenda
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Clinical Trial Prerequisites
Identifies the CMC, preclinical safety, and pharmacology prerequisites for entering early-phase clinical trials.
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Phase 0/I: Study Designs and Objectives
Describes the purpose and process of Phase 0 and Phase I study designs focusing on bioequivalence studies for standard development programs and serious unmet medical needs programs.
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Phase I: Conducting the Clinical Study
Explains how dosage is determined using maximum tolerated dose (MTD), single ascending dose (SAD), and multiple ascending dose (MAD), pharmacokinetics, and pharmacodynamics data required for Clinical Trial Safety Reports.
Features
- Closed Captioning in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
- Transcripts in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
- Course materials
- Real-time tracking
- Progress reporting
- Accessibility features
- Corporate account upgrades
- LinkedIn certificate attachment
- Verified certificates
Justify This Training
View our “Justify This Training” checklist and letter to craft a persuasive request that clearly shows the value of Biotech Primer training to your role and your company. This step-by-step guide helps you highlight ROI, align with business goals, and increase your chances of getting this course approved.
FAQ
Our Executive
Certifications
Cannot make our live class? Consider one of our Executive Certifications.

Drug Development Executive Certification
- CPE:13.50 Credits
- Time:10.5 Hours
- Total:12 Courses

Drug Manufacturing Executive Certification
- CPE:14.50 Credits
- Time:10 Hours
- Total:11 Courses


