Clinical Performance Studies for In Vitro Diagnostics
Ensuring comprehensive Clinical Evidence and clinical performance is a challenging process. Notified Bodies often highlight that initial submission packages are incomplete, with over 40% of deficiencies relating to clinical evidence.Â
QbD Group holds the key to success: EXPERIENCE.Â
Partnering with us means:Â
- access to top experts specializing in IVDR;
- we relieve your team of burdens, accelerate your timelines, and ensure you get it right the first time;
- over 23 years of experience in the IVD sector;
- more than 300 performance evaluation studies conducted in the past 5 years.
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Our IVD experts are happy to support you in your Clinical Performance Studies for IVD. Don’t hesitate to contact us for more information.
Part of QbD Group
This service is supported by Qarad
The Complexities of IVD Clinical Performance Studies
As a leading full-service Contract Research Organization (CRO), we specialize in supporting In Vitro Diagnostic (IVD) manufacturers in navigating the complexities of clinical performance studies with ease, ensuring compliance with all relevant regulations and standards.
To ensure the safety and performance of IVD devices, the IVD Regulation (EU) 2017/746 and the World Health Organization (WHO) have defined stringent requirements that manufacturers must comply with. According to the EU Regulation on In Vitro Diagnostic products, an IVD Performance Evaluation should encompass three key aspects:
- Scientific validity reportÂ
- Clinical performance studiesÂ
- Analytical performance studiesÂ
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Qarad experts leverage their in-depth knowledge of IVD regulations and guidelines to help clients generate high-quality clinical evidence that complies with all applicable standards and guidance. This ensures the performance of your IVD devices is thoroughly demonstrated.
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We offer clinical performance studies in collaboration with renowned clinical laboratories, blood banks, and state-of-the-art private laboratories across Europe.Â
Our Comprehensive Clinical Performance Study Services:
- 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:Â our experts craft tailored Clinical Performance Study Protocols (CPSP) for your IVD.
- Regulatory Support: we 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).
As a sponsor, you can be confident that we will handle every aspect of the clinical performance study for your IVD, leaving you free to focus on your core business activities.
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Why QbD Group?
We provide customized and cost-effective services that adhere to the highest regulatory standards, ensuring full compliance with:Â
- IVD Regulation (EU) 2017/746
- Common Specifications (EU) 2022/1107, when applicable
- ISO 20916:2019 – IVD Medical Devices – Clinical Performance Studies Using Specimens from Human Subjects – Good Study Practice
- WHO-PQ Technical Specification Series
- National or Regional Requirements for Ethics Committee Approval
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Our services offer numerous benefits, including:
- Regulatory Compliance:Â ensure adherence to regulatory requirements.
- Established Network:Â access our network of renowned and qualified laboratories or receive support in site selection and qualification.
- Tailored Studies:Â customize performance studies to suit your specific IVD.
- Notified Bodies recognition:Â guarantee quality esteemed by Notified Bodies.
So, why choose us?
- Global Recognition: we are globally acknowledged as true experts in IVDR compliance, delivering top-tier, compliant services.
- Comprehensive Offering: from initial study design to final closure, we offer a complete spectrum of CRO services.
- Extensive Experience: with a track record of over 300 studies for IVDs in infectious diseases, compliant with IVDR and/or WHO requirements, we bring unparalleled expertise to every project.
- Diverse Environments: we excel in various intended user environments, including clinical labs, near-patient test settings, and self-test studies.
- Certified Excellence: Qarad holds ISO 13485 & ISO 27001 certifications, ensuring the highest standards of quality and security.
Linked Services
We organize performance studies to verify the analytical performance of your In Vitro Diagnostics (sample type equivalency, anticoagulant equivalency, whole system failure, precision, …) in collaboration with high-standard private labs.
Whether you are developing a novel IVD device or navigating the transition from IVDD to IVDR, we provide expert guidance to help you outline the optimal path for demonstrating clinical evidence. Our consultants consider device classification and existing evidence to tailor strategies that meet regulatory requirements and industry standards.
Leveraging our extensive database of seroconversion data across various parameters, we offer seroconversion analysis services. Our advanced analytics enable precise interpretation and understanding of serological conversion patterns, empowering informed decision-making and enhancing the efficacy of your IVD development process.
Beyond clinical performance study documentation, we have a dedicated team of IVD medical writing experts proficient in writing comprehensive documentation. From Performance Evaluation Plans to reports (PEP and PER) and systematic literature searches, our team ensures attention to detail in every aspect of scientific validity, state-of-the-art reporting, clinical performance reporting, and post-market performance follow-up.
Entrust QbD Group as your legal representative, ensuring compliance and seamless navigation of regulatory frameworks when conducting your performance evaluation studies. Our experienced professionals provide comprehensive support, safeguarding your interests and facilitating regulatory compliance throughout the product lifecycle.
Contact us
Interested in our PES service? Don’t hesitate to contact us and provide the details of your request including scope, IFU (if available) and expected timelines. We will contact you shortly to discuss these details and further steps.
