09.14.24 -- Clinical Leader Best Of August

As a former FDA investigator, Vincent Cafiso has heard — and seen — it all when it comes to what NOT to do during an FDA inspection. Here he gives some good advice on who you should have present in the room during an inspection and how you should interact with the investigator.

To prepare for conversations with investors, biotechs should know the “who,” the “why,” and the “when” of their clinical trial setup. Experts from LongeVC explain.

Consultant Aurea Flores, Ph.D. explains why traditional or Agile project management methodologies alone can't determine the success of opening a clinical trial.

By following this checklist, research teams can enhance organizational efficiency, maintain compliance with regulatory standards, and confidently navigate the complexities of documentation management.

Uncover how an industry pioneer and veteran biotech benefited from this solution after struggling with complexity and consistency when it came to its approach to clinical trial feasibility.

A novel solution has emerged to tackle the inefficiency and errors in manual data re-entry during clinical trials, streamlining data entry, eliminate application switching, and benefit all stakeholders.