Books

Books by David Lew

Practical titles for clinical research professionals, regulatory affairs learners, graduate students, and clinical operations teams.

Clinical Research Project Management: Operational Leadership for Clinical Trials book cover

Clinical Research & Regulatory Affairs

Clinical Research Project Management

Operational Leadership for Clinical Trials

A practical guide for planning, coordinating, and leading clinical trial work across teams, timelines, vendors, and operational constraints.

For: Clinical research project managers, clinical operations professionals, graduate students, sponsors, CRO teams, and site-facing collaborators.

FDA Regulatory Affairs: Operational Guidance for Clinical Development book cover

Clinical Research & Regulatory Affairs

FDA Regulatory Affairs

Operational Guidance for Clinical Development

A concise operational reference for clinical development teams learning how FDA regulatory affairs work connects with study planning, documentation, and execution.

For: Regulatory affairs learners, clinical research professionals, graduate students, clinical operations teams, sponsors, and CRO collaborators.