关于本白皮书
本资源涵盖的关键主题
Performance studies generate the clinical evidence needed to support regulatory approval of in vitro diagnostic devices and companion diagnostics.
Under both European and U.S. frameworks, the Sponsor carries ultimate responsibility for the scientific validity, ethical conduct and regulatory compliance of the study.
However, the way sponsorship is structured can significantly influence:
- regulatory accountability
- control of clinical evidence
- operational efficiency
- data ownership for regulatory submissions
This white paper clarifies the responsibilities attached to the Sponsor role and provides practical guidance for manufacturers, pharmaceutical partners and CROs involved in IVD performance studies.
What you'll learn
Key takeaways from this document
In this white paper, you'll discover:
- The regulatory responsibilities of Sponsors under EU IVDR, FDA IDE and ISO 20916
- Which activities can be delegated to CROs and which responsibilities cannot
- Key considerations when selecting a CRO for IVD performance studies
- Different sponsorship models in combined drug–diagnostic studies
- Practical strategies to ensure compliant and scientifically robust performance studies
关于作者
15 years of experience in IVD field · Business Unit Manager IVD CRO
IVD Clinical Evidence and Medical Writing. IVD Product Development and IVDR Compliance. Strategic leadership & Consultancy.
关于作者
MSc Biomedical Sciences · Business Unit Manager RA IVD & Representative Services
With over 20 years of experience in the diagnostics industry, Kirsten leads the IVD Regulatory Affairs business unit at QbD Group, guiding regulatory strategy and compliance across all IVDs with a focus on companion diagnostics.
