--- title: "PrecisionDx (CDx) | QbD Group" description: "End-to-End Companion Diagnostics and Precision Medicine Expertise We specialize in synchronizing Pharma and IVD workstreams to ensure the seamless integration…" url: https://qbdgroup.com/en/industries/companion-diagnostics type: "Page" language: en publisher: "QbD Group" citation: "QbD Group, \"PrecisionDx (CDx) | QbD Group\", https://qbdgroup.com/en/industries/companion-diagnostics" --- Pharma & Biotech # PrecisionDx (CDx) End-to-End Companion Diagnostics and Precision Medicine Expertise We specialize in **synchronizing Pharma and IVD workstreams** to ensure the seamless integration of diagnostics within clinical development. Our expertise covers the **entire lifecycle of a Companion Diagnostic (CDx)**, providing a unified strategy that satisfies both drug and device regulatory requirements. From the initial **RA strategy and project management** to the complex **submission and authorization of Performance Studies**, we handle the heavy lifting of compliance. This includes specialized **Legal Representation and Sponsor Delegation** services to ease the administrative burden on international teams. To ensure data integrity and clinical readiness, we provide rigorous **Test Site Monitoring**, ensuring that every diagnostic touchpoint in your clinical trial meets the highest global standards for authorization. Our approach ## Powering precision medicine — enabling CDx success QbD Group partners with both pharma sponsors and IVD teams to accelerate precision medicine programs and companion diagnostic (CDx) development. Our integrated team aligns **biomarker strategy, assay development, clinical execution, and global regulatory pathways** to deliver faster, safer, and compliant drug–diagnostic co-development. From early biomarker validation and clinical development strategy to **FDA Q-Sub/PMA, IVDR Annex XIV, ISO 20916 clinical studies**, and quality system readiness, QbD Group serves as a single, unified partner across the entire precision medicine and CDx lifecycle. We bridge translation science, regulation, and clinical operations to bring your therapy and diagnostic to patients sooner. Key challenges we address #### Cross-functional complexity CDx programs require alignment between pharma and IVD regulatory pathways, clinical development strategies, and quality systems — often across different organizations. #### Dual regulatory frameworks Navigating both pharmaceutical and IVD regulations simultaneously under IVDR and CTR creates risk of misalignment, delays, and compliance gaps. #### Performance study execution Designing and executing Annex XIV-compliant clinical performance studies while coordinating with pharmaceutical sponsors, CROs, and test sites. #### Sponsor delegation complexity Pharma and diagnostic companies increasingly delegate sponsor responsibilities, requiring trusted partners to ensure full IVDR and CTR compliance. Podcast ### IVDs in Clinical Trials: The Sponsor's Survival Guide In this episode, Kirsten and Annelies discuss the challenges pharma sponsors face when integrating IVDs into clinical trials — and how to navigate IVDR and CTR requirements with confidence. Featuring: Kirsten & Annelies [Listen now](https://qbdgroup.com/en/podcasts/ivds-in-clinical-trials) How it works ## Our structured approach ### RA Strategy & Project Management Define your CDx regulatory strategy, align drug-diagnostic co-development timelines, and coordinate cross-functional project management. ### Sponsor Delegation Services Act as your Sponsor Delegate for IVD/CDx performance studies, ensuring full IVDR and CTR compliance while you retain overall sponsor oversight. ### Legal Representation (IVDR Art. 58(4)) Represent your organization for performance studies in the EU, ensuring full IVDR-compliant oversight and liaison with competent authorities. ### Performance Study Design & Execution Design and implement Annex XIV-compliant clinical performance studies, including CPSP development, site qualification, and ISO 20916:2024 monitoring. ### Test Site Monitoring Identify, assess, and qualify sites with risk-based monitoring, ensuring data integrity and clinical readiness across all diagnostic touchpoints. ### Submission & Authorization Prepare submission packages, manage competent authority and ethics committee interactions, and guide you through the review process. ## 300+ studies completed across Europe From feasibility to post-market, our dedicated IVD CRO team brings deep regulatory knowledge and clinical expertise to every study — ensuring first-time-right submissions and faster market access. Key benefits ## What you gain ### Unified drug–diagnostic strategy One partner managing both pharma and IVD regulatory pathways for seamless co-development across the entire CDx lifecycle. ### Faster time to market Aligned timelines, coordinated submissions, and integrated clinical evidence reduce delays in precision medicine programs. ### Reduced compliance risk Cross-functional expertise minimizes gaps between drug and diagnostic development, IVDR and CTR requirements. ### Sponsor delegation confidence Full compliance, visibility, and strategic alignment under IVDR and CTR while you retain overall sponsor oversight. ### Global regulatory coverage From FDA Q-Sub/PMA to IVDR Annex XIV and ISO 20916, we cover global regulatory pathways for CDx programs. " > QbD IVD | Qarad helped us navigate the IVDR transition with confidence and precision. Their expert guidance and true collaboration reinforced our credibility with pharmaceutical partners. Russell Henderson Sr. Director Regulatory Affairs Myriad Genetics, Inc. Our services ## Our companion diagnostics services Comprehensive CDx support spanning both the diagnostic device and the medicinal product. ### Device support Our services in device development encompass strategic guidance, project management, and comprehensive operational support throughout all phases of CDx development: Notified Body engagement : Support with selection, contracting, and ongoing liaison. Submission and review support : Guidance through the submission and review process with the Notified Body. Quality Management System implementation : Assistance in setting up or optimizing a compliant QMS. Clinical evidence strategy : Define an optimal, compliant, and pragmatic approach to demonstrate scientific validity, analytical performance, and clinical performance. Clinical performance study design & implementation : Design and full-service execution of Annex XIV-compliant performance studies in the EU. Legal representation : Acting as your legal representative for study applications under IVDR Article 58(4). Medical writing & submission package : Preparation or review of study documentation, with tailored submission strategies for each EU member state. Risk management : Support in developing a comprehensive risk management file in line with ISO 14971. Representative services : Acting as your EU Authorized Representative, UK Responsible Person (UKRP), and Swiss Authorised Representative. IVDR & CDx Training : On-site or remote training on regulatory and operational aspects of CDx studies across the EU, UK, and Switzerland. Why QbD IVD | Qarad? ## Your single partner for the full CDx lifecycle Integrated drug–diagnostic expertise one team managing both pharma and IVD regulatory pathways for seamless co-development. End-to-end CDx support from biomarker strategy and clinical performance studies to IVDR submissions and post-market compliance. Sponsor delegation confidence full compliance, visibility, and strategic alignment under IVDR and CTR while you retain overall oversight. Industry-leading client portfolio supporting 8 of the world's top 10 IVD companies and partnering with 11 of the top 20 pharma companies on CDx programs. 80+ CDx projects 40 In-house IVD consultants 250+ IVDR tech files completed 26 Years IVD experience FAQ ## Frequently asked questions ### ### Related insights [View all](https://qbdgroup.com/en/knowledge-center) [Free ToolCDx Readiness Checklist](https://cdx-readiness.qbdgroup.com/) ## Ready to accelerate your CDx program? Whether you are developing a first-in-human CDx study, managing an IVDR transition, or seeking a sponsor delegate, our multidisciplinary teams combine IVD, pharmaceutical, and clinical expertise to support the full CDx lifecycle. Contact us --- Source: https://qbdgroup.com/en/industries/companion-diagnostics — © QbD Group. Quote freely with attribution and a link back.