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 East Africa. 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.

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.

Discover how we can support you

How can we help?

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 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).

Why Labmark IVD?

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

East Africa + EU Regulatory Insight: We speak both “languages”—deep knowledge of Tanzanian compliance and international regulations.
Tailored Transition Plans: We don’t use one-size-fits-all models. Your roadmap is customized to your internal capacity, documentation maturity, and timelines..
End-to-End Expertise: From QA and RA to clinical evaluation and technical writing—we have the local and international specialists you need

Diverse environments: We excel in various intended user environments, including clinical labs, near-patient test settings, and self-test studies.
Accelerated Compliance Our structured, hands-on support shortens your time-to-submission by up to 50%.

IVD Clinical Performance Studies - Clinical - QbD Group (1)

Why Labmark D 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.