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IVD Clinical Performance Studies - Clinical - QbD Group

Experts in IVD Clinical Performance Studies

Ensuring comprehensive clinical evidence and demonstrating 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

Are you looking for an experienced partner to generate trustworthy and accurate clinical performance for your IVD device, ensuring full regulatory compliance?

As a leading full-service Contract Research Organization (CRO), we can help you overcome the complexities that come with clinical performance studies and ensure they are conducted with the highest level of expertise and quality.

 

What are IVD clinical performance studies?

IVD clinical performance studies are essential in assessing and confirming the safety and performance of In Vitro Diagnostic Medical Devices (IVD). The IVD Regulation (EU) 2017/746, ISO20916:2024, and the World Health Organization (WHO) have defined stringent requirements that manufacturers must comply with.

 

We offer clinical performance studies in collaboration with renowned clinical laboratories, blood banks, and state-of-the-art private laboratories across Europe. 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.

 

IVD Clinical Performance Studies - Clinical - QbD Group

Why are these studies important?

  • Clinical Performance Studies are not just a regulatory requirement – they’re critical for proving that your IVD device performs reliably and safely under real-world conditions.
  • These studies help safeguard the health and safety of patients and users, while also ensuring that your device meets the necessary criteria for market approval.
  • With evolving regulations and growing industry standards, having accurate clinical evidence is essential to gaining regulatory approval and ensuring market success for your IVD devices.

 

How can we help?

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, and endocrinology. 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.

Study strategy

Study strategy

We help you create a robust strategy, documented in the Performance Evaluation Plan (PEP).

Site selection

Site selection

We identify and qualify the best study sites for your project.

Protocol development

Protocol development

Our experts craft tailored Clinical Performance Study Protocols (CPSP) for your IVD. 

Regulatory support

Regulatory support

We assist with Ethical Committee and National Competent Authority submissions. 

Training & monitoring

Training & monitoring

We provide training and continuous site monitoring to ensure protocol adherence. 

Data analysis & reporting

Data analysis & reporting

We conduct thorough data analysis and compile detailed Clinical Performance Study Reports (CPSR). 

Our expertise

At QbD Group, we bring deep therapeutic expertise to every clinical project. Our Clinical Solutions team is particularly specialized in supporting studies within three key areas: infectious diseases, oncological conditions, and endocrinology. With hands-on experience and a solid understanding of regulatory and clinical complexities, we help our partners navigate these high-impact therapeutic fields with confidence and precision.

Infectious diseases

  • Covid-19
  • HIV
  • HCV
  • Syphilis
  • Influenza
  • Malaria

Oncological conditions

  • Bladder cancer 
  • Breast cancer 
  • Lymphoma 
  • Liver cancer (Hepatocellular Carcinoma, HCC) 
  • Colorectal cancer (Metastatic CRC. mCRC) 
  • Pancreatic cancer 
  • Non-Small Cell Lung Cancer (NSCLC) 

Endocrinology

  • Diabetes Mellitus
  • Hypercholesterolemia
  • NASH
  • Esophagitis 
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Probably the best place to go in Europe for IVD consulting needs and clinical services.

GNA Biosolutions GmbH

Fast Molecular Tests
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Why QbD IVD | Qarad?

From initial study design to final closure, we offer a complete spectrum of CRO services. Here’s why manufacturers trust us globally:

  • Regulatory compliance: We ensure your studies fully comply with IVDR, Common Specifications, ISO 20916:2019, WHO-PQ Technical Specification Series, and national or regional requirements for Ethics Committee approval.
  • Experienced network: Benefit from our strong network of renowned clinical laboratories, blood banks, and private laboratories across Europe.
  • Tailored solutions: We offer customized services designed to meet the specific needs of your IVD device.
  • Diverse environments: We excel in various intended user environments, including clinical labs, near-patient test settings, and self-test studies.
  • Proven track record: With over 300 studies completed, we bring unparalleled experience in infectious disease diagnostics and compliance with IVDR and WHO requirements.
  • Notified Bodies recognition: We offer guaranteed quality esteemed by Notified Bodies
  • Certified excellence: We hold ISO 13485 & ISO 27001 certifications, ensuring the highest standards of quality and security.
IVD Clinical Performance Studies - Clinical - QbD Group (1)

Why QbD IVD | Qarad?

From initial study design to final closure, we offer a complete spectrum of CRO services. Here’s why manufacturers trust us globally:

  • Regulatory compliance: We ensure your studies fully comply with IVDR, Common Specifications, ISO 20916:2019, WHO-PQ Technical Specification Series, and national or regional requirements for Ethics Committee approval.
  • Experienced network: Benefit from our strong network of renowned clinical laboratories, blood banks, and private laboratories across Europe.
  • Tailored solutions: We offer customized services designed to meet the specific needs of your IVD device.
  • Diverse environments: We excel in various intended user environments, including clinical labs, near-patient test settings, and self-test studies.
  • Proven track record: With over 300 studies completed, we bring unparalleled experience in infectious disease diagnostics and compliance with IVDR and WHO requirements.
  • Notified Bodies recognition: We offer guaranteed quality esteemed by Notified Bodies
  • Certified excellence: We hold ISO 13485 & ISO 27001 certifications, ensuring the highest standards of quality and security.

What our clients say about us

At QbD Clinical, client feedback isn’t just a checkbox, it’s part of our DNA.
We’re proud to share our 2024 client satisfaction scores, reflecting the trust and collaboration we build every day.

4.5/5 average client rating

4.5/5 average client rating

Our clients value our hands-on approach, regulatory insight, and therapeutic expertise.

288 clinical studies

288 clinical studies

From feasibility to post-market, we’ve supported trials across the full IVD lifecycle.

100+ happy clients

100+ happy clients

Trusted by global MedTech and IVD companies for clinical excellence and flexibility.

4.5/5 – Recommended by our clients

4.5/5 – Recommended by our clients

Strong referrals highlight the value we bring to every collaboration.

4.8/5 – Expertise across clinical domains

4.8/5 – Expertise across clinical domains

Our clients value the high-level knowledge and skills our teams bring.

4.6/5 – High willingness to reuse our services

4.6/5 – High willingness to reuse our services

We build trust and long-term partnerships through consistent delivery.

4.6/5 – Clear communication & responsiveness

4.6/5 – Clear communication & responsiveness

Clients appreciate our quick replies and transparent collaboration.

4.6/5 – Consistently meeting quality expectations

4.6/5 – Consistently meeting quality expectations

We maintain high standards from kickoff to close-out.

Always glad to share our expertise

QbD Clincial offers a comprehensive suite of services tailored to address the unique needs of medical device manufacturers.
QualityAssurance_Get in touch

Quality Assurance

  • Implementation of FDA, EMA, FAHMP, and ISO standards (ISO13485, ISO14971, etc.)

  • Internal and external audits by certified lead auditors.

  • Lifecycle management for Medical Device Software and digital health solutions.
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Clinical Services

  • Strategy and protocol development for clinical evidence generation.

  • Site selection, monitoring, and regulatory support.

  • Comprehensive medical writing, incl. scientific validity reports and post-market clinical follow-up documentation.
RA_Get in touch

Regulatory Affairs

  • CE Marking, FDA clearance, and market entry strategies.

  • Technical documentation and submission packages for MDR and global markets.

  • PRRC services, in-country representation, legal representation, and post-market regulatory support.

Your journey from idea to patient

We support you in every stage of your device development — from ideation to post-market surveillance.
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Recent client cases: combining compliance & clinical expertise

Explore how we helped two IVD manufacturers navigate complex study requirements and compliance frameworks — from IVDR and WHO alignment to full study sponsorship.

Combination of IVDR & WHO requirements

Combination of IVDR & WHO requirements

  • Helped bring a Class D product for near-patient and self-testing to the EU market and achieve WHO-PQ approval.

  • Combined IVDR and WHO requirements to reduce sample count and streamline processes.

  • Set up 4 distinct studies:

    • Clinical study (IVDR + WHO)

    • Near-patient test (IVDR)

    • Self-test (IVDR)

    • Self-test (WHO)

  • Acted as legal representative for EC/CA approvals.

Result: First-time-right compliance, fewer samples, and ongoing collaboration on 4 additional products.

Study Sponsorship Support

Study Sponsorship Support

  • Took over IVDR performance study sponsorship for a U.S.-based IVD manufacturer.

  • Managed 8,000 samples across 100+ sites in 10 EU countries.

  • Provided support for study design, medical writing, GMS & GDPR compliance.

  • Coordinated EC/CA documentation and full Dx site monitoring.

  • Acted as legal representative throughout the study lifecycle.

Result: Streamlined execution, expert guidance, and long-term planning flexibility.

contact-mail

Get in touch

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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