Overcoming IVDR Compliance Challenges in Early Clinical Development
Time: 4:25 pm
day: Day 1 - Track B (2)
Details:
- IVDR requires robust scientific validity, analytical performance, and clinical performance data, with pharma sponsors now needing to conduct a performance study in parallel to their phase I/II clinical trial in all EU member states participating in the IMP trial
- This more complex technical package is coupled with an expanded documentation file per device and subsequently requires increased specialist regulatory knowledge and capacity within the sponsor’s project team and/or additional external support
- To address these pain points, ARC has established a boutique accredited laboratory and sponsor delegation service, capable of analytical validation and sample analysis from global patients, across a range of technologies, with regulatory compliance and patient safety at the forefront
