INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES

CLINICAL TRIAL REGULATORY SOLUTIONS

  • When the complexities of designing and executing cancer trials in a highly competitive market can mean delays in delivering urgently needed treatments to patients, it pays to have a trusted partner by your side.

  • Strategic product development and CMC regulatory planning start early on at the pre-IND stage and apply to the entire development lifecycle through to post-approval.

  • Phlexglobal's precise, proven methodology delivers a high-quality migration of your Trial Master File to the destination system, typically just 4-6 weeks after receiving all documents from the source system.

  • Trial protocol strategies for FDA approval must also meet the needs of global regulators, if a therapy is to be commercialized worldwide. Michael Krams, chief quantitative medicine officer at Exscientia explains how R&D leaders should think about FDA and ex-U.S. product approval.

  • How do drug developers make decisions about what to include, and what to leave out, of a Phase 2 clinical trial? Mitchell Katz, SVP, global clinical operations at Kyowa Kirin discusses collecting competitive intelligence and forging relationships with regulators.

REGULATORY MULTIMEDIA