Designing for Success: Navigating Early-Phase Translational Medicine Studies to Expedite EU & RoW Patient Inclusion
- Proven strategies for designing and delivering successful IVD and CDx regulatory submissions and clinical studies
- The application of the EU IVDR Article 5(5) Health Institution Exemption – and how this pathway can offer flexibility and speed for pharma-led precision medicine programs
- Practical insights and real-world case studies from ARC’s collaborations with pharmaceutical and diagnostic teams on early-phase translational and precision medicine trials