--- title: "Collaborative Responsibilities in Combined Studies" description: "Based on the European Commission's COMBINE analysis of 402 combined-study applications, this white paper maps how regulatory, quality, legal and operational functions can divide — and align — responsibilities when a clinical trial and an IVDR performance study run side by side in drug–diagnostic co-development." url: https://qbdgroup.com/en/downloads/collaborative-responsibilities-in-combined-studies type: "White paper" language: en published: 2026-09-11 author: "Kirsten Van Garsse" category: "Regulatory Affairs" publisher: "QbD Group" citation: "QbD Group, \"Collaborative Responsibilities in Combined Studies\", https://qbdgroup.com/en/downloads/collaborative-responsibilities-in-combined-studies" --- # Collaborative Responsibilities in Combined Studies > Based on the European Commission's COMBINE analysis of 402 combined-study applications, this white paper maps how regulatory, quality, legal and operational functions can divide — and align — responsibilities when a clinical trial and an IVDR performance study run side by side in drug–diagnostic co-development. ## About this white paper Combined studies are no longer the exception in drug–diagnostic co-development. In its COMBINE analysis of 402 combined-study applications, the European Commission found that 343 paired a clinical trial with an IVDR performance study — and 86% were multinational. Yet most sponsors still manage the two studies as separate projects, with separate teams, timelines and obligations. This white paper, written by Kirsten Van Garsse, Business Unit Manager RA IVD & Representative Services, maps what combined-study governance actually requires when two companies develop a companion diagnostic together. It looks at how regulatory affairs, quality assurance, legal and operational functions divide — and too often leave unassigned — responsibilities across sponsorship, submissions, site oversight, safety reporting and contractual arrangements. It then sets out a practical framework that starts with ownership: agreeing who is legally responsible, who performs each activity and who is accountable for oversight, before submissions begin. With the EU's coordinated assessment pilot and the proposed MDR/IVDR revision and EU Biotech Act signalling closer alignment between drug and device review, the organizations that formalize this collaboration now will be the ones that move fastest later. ## Key Takeaways - Why combined studies fail at the seams between the clinical trial and the IVDR performance study, not within either study itself - How the four functions that decide success — regulatory affairs, quality assurance, legal and operations — divide responsibilities between pharma and IVD partners, and where the gap shows up in practice - What the five highest-risk handover points are: sponsorship, submissions, site oversight, safety reporting and contractual arrangements - A practical framework for assigning ownership before submissions begin, anchored in the Combined-Study Governance Alignment Session - Where the regulatory landscape is heading: the coordinated assessment pilot, the proposed MDR/IVDR revision and the EU Biotech Act ## Download this white paper Complete the form on this page to receive your copy. --- Source: https://qbdgroup.com/en/downloads/collaborative-responsibilities-in-combined-studies — © QbD Group. Quote freely with attribution and a link back.