Preface

In this book

This book is designed for people who are interested in using AI for clinical development. Each part of the book makes certain assumptions about the readers’ background:

• Part 1, Principles: a shared vocabulary for vibe coding, agentic workflows, and harness engineering, and how they fit together as a self-validating loop. No prior AI experience required.
• Part 2, Vibe coding: directing AI assistants to write code from natural-language intent. Comfort with a text editor is assumed.
• Part 3, Agentic workflows: composing multi-step autonomous workflows that handle research, analysis, and reporting tasks. Some scripting background (R or Python) is helpful.
• Part 4, Harness engineering: building the evaluations, guardrails, and feedback signals that keep agents honest, reproducible, and submission-ready. Familiarity with version control and CI/CD is helpful.
• Part 5, Governance: organizing AI-assisted work for regulatory submission, audit, and team collaboration. Familiarity with regulated environments is helpful but not required.