Matthew Maland
Seminars
Wednesday 7th October 2026
Roadmap for Global Clinical Trial Assays: Leveraging Distributed Kits for CDx Success
12:40 pm
- An overview of the major steps needed to prepare a commercially available distributed IVD kit for use as a Clinical Trial Assay in global clinical trials
- Discussing regulatory strategy, assay validation, laboratory implementation, training, quality oversight, and how early planning can reduce risk when transitioning from CTA use to CDx approval
