Pharma and diagnostic companies increasingly delegate sponsor responsibilities for IVD or CDx performance studies to trusted partners with the infrastructure, systems, and oversight required under IVDR and the Clinical Trials Regulation (CTR).
Alternative focused on IVD Sponsor Delegation only: Pharma and diagnostic companies increasingly rely on experienced partners to take responsibility for the IVD or CDx component of their clinical performance studies. By delegating defined sponsor duties to QbD Group, you gain end-to-end regulatory, quality, and clinical support under IVDR, fully aligned with CTR principles. This approach ensures compliance, visibility, and strategic alignment throughout your study, while allowing you to retain overall sponsor oversight.
QbD Group acts as your Sponsor Delegate - taking care of defined sponsor duties while ensuring full compliance, visibility, and strategic alignment.
This enables you to maintain overall sponsor control while benefiting from QbD’s cross-functional execution and compliance management.
Our Sponsor Delegation Capabilities
This delegated model is ideal for biopharma and diagnostic sponsors performing biomarker or CDx performance studies in the EU or UK that require an experienced partner to handle end-to-end sponsor activities.
Pharma and diagnostic companies increasingly delegate sponsor responsibilities for IVD or CDx performance studies to trusted partners with the infrastructure, systems, and oversight required under IVDR and the Clinical Trials Regulation (CTR).
Alternative focused on IVD Sponsor Delegation only: Pharma and diagnostic companies increasingly rely on experienced partners to take responsibility for the IVD or CDx component of their clinical performance studies. By delegating defined sponsor duties to QbD Group, you gain end-to-end regulatory, quality, and clinical support under IVDR, fully aligned with CTR principles. This approach ensures compliance, visibility, and strategic alignment throughout your study, while allowing you to retain overall sponsor oversight.
QbD Group acts as your Sponsor Delegate - taking care of defined sponsor duties while ensuring full compliance, visibility, and strategic alignment.
This enables you to maintain overall sponsor control while benefiting from QbD’s cross-functional execution and compliance management.
Our Sponsor Delegation Capabilities
This delegated model is ideal for biopharma and diagnostic sponsors performing biomarker or CDx performance studies in the EU or UK that require an experienced partner to handle end-to-end sponsor activities.
Our services in device development encompass strategic guidance, project management, and comprehensive operational support throughout all phases of CDx development:
At QbD Group, we understand that the successful development of a medicinal product that relies on a companion diagnostic (CDx) requires a coordinated and well-structured development plan. The interdependence between the drug and the diagnostic impacts key regulatory, clinical, and quality aspects throughout development — from proof of concept to marketing authorisation.
Building on the companion diagnostic aspects, at QbD Group, we can also support the development of the medicinal product, ensuring that all related requirements are seamlessly integrated into the regulatory and development strategy.
Services provided by QbD Group in this context include, but are not limited to:
We bring an integrated perspective: our team understands not only the regulatory expectations but also how the medicinal product’s development, evidence generation, and documentation must evolve alongside its companion diagnostic. This understanding ensures that the medicinal product dossier remains robust, compliant, and strategically aligned with market access objectives.
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Whether you are developing a first-in-human CDx study, managing an IVDR transition, or seeking a sponsor delegate for the IVD/CDx component of your study, QbD Group provides regulatory assurance, operational excellence, and strategic foresight to bring your diagnostic innovation to patients safely and efficiently.
Contact our team to discuss your study design, sponsor delegation needs, or regulatory challenges.
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