07.12.25 -- Clinical Leader, The Best Of June

During the last year I have interviewed six former FDA investigators and a regulatory expert who has been involved with more than 250 inspections. From all those interviews, I’ve culled the following list of takeaways that I hope you will find useful when preparing for any type of regulatory inspection.

Kulkarni Law Firm Senior Attorney Edye T. Edens explores the risks embedded in clinical trial start-up activities, such as site activation, contract execution, delegation, and cross-border data flows.

MindBio Therapeutics CEO Justin Hanka details the company’s Phase 2a clinical trial investigating the use of a take-home microdosing regimen for depression.

While both trial auditing and trial monitoring have the same goal of protecting participant safety and rights, they are two separate yet important pieces of the clinical trial process.

The FDA's new guidance outlines a future where AI models support regulatory submissions, taking a pivotal step toward modernizing regulatory science.

The Regional Site Manager (RSM) monitoring model eliminates numerous clinical trial risks by leveraging efficient, start-to-finish site management by a single, expert point of contact.