--- title: "IVD Clinical Performance Studies — Clinical Solutions | QbD Group" description: "Design and run IVD clinical performance studies that meet IVDR evidence requirements, from protocol and site selection to data analysis and reporting." url: https://qbdgroup.com/en/services/clinical-solutions/ivd-clinical-performance-studies type: "Page" language: en publisher: "QbD Group" citation: "QbD Group, \"IVD Clinical Performance Studies — Clinical Solutions | QbD Group\", https://qbdgroup.com/en/services/clinical-solutions/ivd-clinical-performance-studies" --- # In Vitro Diagnostics CRO Specialized in IVD Clinical Performance Studies As a leading IVD CRO, QbD is the trusted partner for **50+ IVD manufacturers**, resulting in **300+ clinical performance studies** delivered. Our dedicated IVD clinical teams combine **industry expertise, hands-on execution, and an established site network** to deliver **IVDR and/or WHO compliant** studies. From **study design and submissions to site management, reporting, and close-out**, we ensure your clinical evidence meets the highest regulatory standards. Choose the support model that fits your needs: **full-service CRO delivery or targeted expertise** at any stage of your project. How can we help? ## Our IVD Clinical Performance Services We are a CRO specialized in In Vitro Diagnostics (IVD), with in-depth expertise in the unique challenges of IVD performance studies. Our focus areas include infectious diseases, oncology, cardiology and many more. Unlike CROs that treat IVD support as an add-on to their medical device services, we deliver dedicated expertise and streamlined support across the entire IVD lifecycle. We are a flexible partner, supporting both full-service outsourcing, as well as one-off solutions. ### Study strategy We help you create a robust strategy, documented in the Performance Evaluation Plan (PEP). ### Site selection We identify and qualify the best study sites for your project. ### Protocol development Our experts craft tailored Clinical Performance Study Protocols (CPSP) for your IVD. ### Regulatory support We can act as your legal representative and assist with Ethical Committee and National Competent Authority submissions. ### Training & monitoring We provide training and continuous site monitoring to ensure protocol adherence. ### Data analysis & reporting We conduct thorough data analysis and compile detailed Clinical Performance Study Reports (CPSR). ## 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. Therapeutic expertise ## Our expertise At QbD Group, we bring deep expertise to every clinical project. Our team is specialized in supporting IVD clinical performance studies in areas of infectious diseases, oncological conditions, and others. With hands-on experience and a solid understanding of regulatory and clinical complexities, we help our partners navigate these high-impact disease fields with confidence and precision. ### Infectious diseases - Serology (HIV, HBV, HCV, Syphilis) - Respiratory diseases (Covid-19, Influenza A/B, RSV) - STIs - Tropical diseases (Malaria, Dengue) - Gastrointestinal (C. difficile, H. Pylori) ### Oncology - Bladder cancer - Breast cancer - Lymphoma - Liver cancer (HCC) - Colorectal cancer (mCRC) - Pancreatic cancer - Non-Small Cell Lung Cancer (NSCLC) ### Endocrinology - Fertility (hCG, LH) - Diabetes (Glucose, HbA1C) ### Other - Blood grouping - Hemoglobin - Troponin I - Lipoprotein (a) Our team ## Meet our experts Conducting IVD clinical performance studies requires a unique combination of scientific expertise, regulatory insight, and deep understanding of diagnostic technologies. Discover the dedicated professionals who guide your IVD from concept to clinical success. [Annelies Rotthier](https://qbdgroup.com/en/author/annelies-rotthier) Business Unit Manager IVD CRO 15 years of experience in IVD field - IVD Clinical Evidence and Medical Writing - IVD Product Development and IVDR Compliance - Strategic leadership & Consultancy [Annelies Rombout](https://qbdgroup.com/en/author/annelies-rombout) Senior Consultant IVD CRO 23+ years experience in IVD product development and clinical studies - International experience in R&D and clinical development - Expert in analytical and clinical performance study design, execution, and reporting - Specialized in nucleic acid and protein-based IVD assays, including HLA-typing, infectious diseases, Cystic Fibrosis, Vitamin D, and cardiac diagnostics [Sara Peeters](https://qbdgroup.com/en/author/sara-peeters) Senior Consultant IVD CRO 10+ years experience in point-of-care and IVD development - International experience in assay development, surface chemistry, and molecular diagnostics - Expert in biosensors, assay optimization, and performance evaluation studies - Manages analytical and clinical performance studies for a wide range of IVD products Client satisfaction ## What our clients say about us We're proud to share our 2024 client satisfaction scores, reflecting the trust and collaboration we build every day. 0 clinical studies From feasibility to post-market, we've supported trials across the full IVD lifecycle. 0 + happy clients Trusted by global MedTech and IVD companies for clinical excellence and flexibility. 0.0 /5 average client rating Our clients value our hands-on approach, regulatory insight, and therapeutic expertise. 0.0 /5 recommended by clients Strong referrals highlight the value we bring to every collaboration. 0.0 /5 expertise across domains Our clients value the high-level knowledge and skills our teams bring. 0.0 /5 willingness to reuse We build trust and long-term partnerships through consistent delivery. 0.0 /5 communication & responsiveness Clients appreciate our quick replies and transparent collaboration. 0.0 /5 meeting quality expectations We maintain high standards from kickoff to close-out. Client cases ## Recent client cases: combining compliance & clinical expertise Explore how we helped IVD manufacturers navigate complex study requirements and compliance frameworks. Class D ### Integrated IVDR & WHO Strategy Class D Diagnostic Test - Challenge : Launch a Class D near-patient and self-test diagnostic under IVDR while also securing WHO prequalification. - Approach : Devised a unified IVDR/WHO protocol to eliminate duplication and minimize total samples; executed four targeted studies. - Result : Achieved first-time-right compliance for both IVDR CE-marking and WHO-PQ, cutting sample needs and accelerating time-to-market. IVDR ### Accelerated IVDR Market Access Multiplex Respiratory Antigen Test - Challenge : Secure CE-marking under IVDR for a rapid, multiplex respiratory antigen assay ahead of the busy respiratory-virus season. - Approach : Designed a lean, IVDR-focused clinical performance plan; tapped our EU site network to fast-track sample collection. - Result : Delivered robust clinical evidence on schedule, enabling CE-marking in time for the season. PCR ### Multiplex STI PCR Test Fully Automated PCR Panel - Challenge : Obtain IVDR CE-marking for a fully automated multiplex real-time PCR panel detecting eight low-prevalence STI pathogens. - Approach : Crafted a lean clinical performance evaluation plan, optimized sample-size calculations, and selected EU sites. - Result : First-time-right protocol approval and on-schedule CE-mark submission. Sponsorship ### Study Sponsorship Support U.S.-Based IVD Manufacturer - Challenge : A U.S.-based IVD manufacturer needed an EU-based sponsor to run an IVDR performance study across multiple countries. - Approach : Managed 8,000 samples across 100+ sites in 10 EU countries, covering study design, medical writing, GMS & GDPR compliance. - Result : Successful completion of the multi-country performance study, enabling the client's IVDR submission. Why QbD IVD | Qarad? ## Your trusted partner We support MedTech companies with regulatory expertise across MDR, FDA, IVDR, ISO 14155, ICH-GCP, and our close collaboration with Notified Bodies, enabling trust, transparency, and faster outcomes. MedTech expertise focused exclusively on medical devices, IVD and companion diagnostics. Trusted partner proven track record with innovators and established MedTech companies alike. Quality at every step rigorous processes ensure clinical evidence that meets regulatory expectations. Right-sized solutions on budget we scale our services to match your project needs and timeline. FAQ ## What you need to know ### ## Ready to advance your IVD to market? From study design to final performance evaluation, our IVD specialists are ready to support your in vitro diagnostics journey to IVDR compliance. Contact us --- Source: https://qbdgroup.com/en/services/clinical-solutions/ivd-clinical-performance-studies — © QbD Group. Quote freely with attribution and a link back.