About this white paper
Key topics covered in this resource
Who is responsible for the scientific integrity, regulatory compliance and data reliability of an IVD performance study?
This white paper explains the Sponsor role in IVD clinical performance studies and outlines how responsibilities are defined under EU IVDR, FDA IDE requirements and ISO 20916 good study practice.
It also explores how Sponsors can collaborate with CROs and external partners while maintaining ultimate regulatory accountability.
Learn how to structure sponsorship in standalone or combined studies and ensure that performance data remain robust, compliant and suitable for regulatory submissions.
<!-- cta_url: /en/services/clinical-solutions -->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
