Clinical Trials Phase I

Clinical Trials Phase I: From First-in-Human Design to Safe Dose Escalation

Phase I trials are the highest-stakes entry point in clinical development — decisions made here shape the entire programme. This certified learning path, developed under the expert guidance of Dr. Patricia Kay, equips clinical research professionals with the scientific, regulatory, and operational knowledge needed to design and execute safe, compliant first-in-human studies.

Course Breakdown:

• First in Human Safety Assessment (FIHSA) Dossier: Understand how preclinical safety data is synthesised into the FIHSA dossier to justify the starting dose and support the regulatory decision to proceed to human subjects.
• ICH-GCP: Introduction to Good Clinical Practice: Build the GCP foundation required for all clinical research roles, covering trial conduct standards, investigator responsibilities, and data integrity principles.
• Good Clinical Practice Training Refresher 2026 (ICH-GCP E6 R3): Stay current with the latest GCP revision — understand what changed in E6(R3) and how it applies to Phase I trial operations.
• Pharmacokinetics and Pharmacodynamics for Beginners and Professionals: Master the PK/PD concepts that drive dose selection, exposure-response modelling, and safety monitoring in first-in-human studies.
• Selection of Trial Sites: Learn the criteria and processes for identifying, evaluating, and qualifying Phase I unit sites that meet regulatory and sponsor requirements.
• 21 CFR Part 50 — Informed Consent of Human Subjects: Understand the ethical and regulatory requirements governing informed consent in first-in-human and early phase clinical trials.
• GMP for Clinical Trials Manufacture and Supply: Ensure investigational medicinal products are manufactured, labelled, and supplied in full compliance with GMP requirements for Phase I studies.

Why Choose This Learning Path?

• Expert-Led Curriculum: Developed by Dr. Patricia Kay, a results-focused senior research professional with over 20 years spanning clinical development, health programme management, and regulatory strategy.
• Comprehensive Coverage: From FIHSA preparation and PK/PD fundamentals to GCP, site selection, and IMP supply, this path covers every critical dimension of Phase I operations.
• Flexible Learning: Fully self-paced and online — study on your schedule and revisit content as regulatory guidance evolves.
• Certification: Earn a recognised certificate demonstrating your Phase I competency to sponsors, CROs, and regulatory bodies.

Who Should Enroll?

Whether you are a clinical research associate, study manager, pharmacologist, or regulatory affairs professional preparing to work on first-in-human studies, this path was built for you. It is equally valuable for pharmaceutical and biotech teams building Phase I capabilities or onboarding clinical staff to early-phase development programmes.

Lead the Most Critical Phase in Clinical Development

Join thousands of life sciences professionals who have used GxP Training to build verifiable expertise. In an era where Phase I failures cost millions and delay entire programmes, first-in-human competency is not optional — it is your career foundation. Enroll today.