Clinical Research & Regulatory Affairs
I write about clinical research, regulatory affairs, clinical trial finance, and clinical operations for people doing the work.
Featured books
The Clinical Research & Regulatory Affairs series focuses on project management, FDA regulatory affairs, trial financial management, and the decisions that keep clinical work moving.
Clinical Research & Regulatory Affairs
A Clinical Research Field Guide
A practical guide to how clinical trial money moves through budgets, forecasts, site payments, vendor costs, pass-throughs, invoices, change control, governance, and closeout.
For: Clinical trial project managers, CTMs, budget specialists, site leaders, vendor managers, finance partners, sponsors, CRO teams, and FSP collaborators.
Clinical Research & Regulatory Affairs
Operational Leadership for Clinical Trials
A guide to 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.
Clinical Research & Regulatory Affairs
Operational Guidance for Clinical Development
A reference for clinical development teams learning how FDA regulatory affairs shows up in study planning, documentation, and execution.
For: Regulatory affairs learners, clinical research professionals, graduate students, clinical operations teams, sponsors, and CRO collaborators.
For readers
Plain language for clinical research and regulatory affairs work.
Course-friendly explanations that tie FDA regulations to clinical development.
Common reference points for sponsors, CRO teams, site partners, and cross-functional groups.
Current work in oncology clinical development strategy and delivery.
Coursework in clinical research project management and FDA regulations.
Global clinical research experience across sites, CROs, and clinical operations leadership.
Review the current titles in the Clinical Research & Regulatory Affairs series.