As a specialized Contract Research Organization (CRO) in IVD studies (In Vitro Diagnostics), we provide comprehensive analytical and IVD clinical trials services, including analytical and clinical performance studies
Our services are designed to ensure that your device meets regulatory requirements from the U.S. Food and Drug Administration (FDA) and the European Union’s In Vitro Diagnostic Regulation (IVDR), as well as the Clinical and Laboratory Standards Institute (CLSI) standards, ISO 20916, ISO 14155, and other relevant requirements, including for example the WHO pre-qualification program.
All our services include regulatory affairs support and consulting on regulatory compliance to ensure complete, accurate, and compliant regulatory submissions. Our statistical analysis and documentation preparation for regulatory submissions are designed to meet FDA and IVDR requirements.
Contact us today to learn more about how our IVD Studies can help you meet regulatory requirements and achieve your research objectives.
With extensive experience in conducting clinical research and IVD clinical trials across a range of therapeutic areas, our IVD CRO services are tailored to help you achieve your research objectives. Our team of experts will work with you to design and conduct clinical performance studies, manage and process samples, and provide data management and analysis.
We also offer Electronic Data Capture (EDC) system setup and support, Trial Master File (TMF) management, site qualification visits, and study monitoring.
Discover our range of biomarkers, technologies and applications for your IVD studies.
IVD analytical performance is a critical component of the regulatory approval process for IVD devices, as it demonstrates the device’s ability to produce reliable and accurate results, which is essential for ensuring patient safety and effective clinical decision-making.
The European Union’s In Vitro Diagnostic Regulation (IVDR) and the U.S. Food and Drug Administration (FDA) both require IVD manufacturers to demonstrate the analytical performance of their devices as part of the regulatory submission process.
This typically involves conducting analytical performance studies to evaluate the device’s accuracy, precision, sensitivity, and specificity, as well as other performance characteristics.
Analytical performance refers to the ability of an IVD device to accurately measure the analyte(s) of interest in a clinical sample, while clinical performance refers to the ability of the device to accurately diagnose or predict the presence or absence of a specific medical condition or disease in patients.
While both types of performance are important for regulatory approval, clinical performance is particularly important for demonstrating the device’s ability to produce accurate and reliable results in a clinical setting.
|IVD CRO QUALIFICATION QUESTIONNAIRE||MDx|
|What services does the CRO provide?|
|Project Management, Medical Writing, Data Management, Statistics||✓|
|What devices are the CRO´s Subject Matter Experts in?|
|Applications: Professional use, Point of Care, Self-Tests, Companion Diagnostics. All IVDR Classes.||✓|
|Technology: Immunoassays, NGS, Multiplex, Molecular, Lateral Flow, Microfluidic and others||✓|
|Therapeutic Areas: Infectious Diseases, Physiological Markers, Cancer Screening, Transfusion Medicine, Genetic Testing, Hematology, Hemostasis, Clinical Chemistry, Microbiology||✓|
|Software as a Medical Device/In Vitro Diagnostics||✓|
|Laboratory Developed Tests/ In-house developed tests||✓|
|Does the CRO have specific procedures for IVDs?|
|For Clinical Operations following GCPs||✓|
|For Clinical Operations following GCPS, IVDR and ISO 20916||✓|
|Is the CRO an Expert in the Following Regulations or Standards?|
|ISO 13485, ISO 15189||✓|
|CLSI guidance, FDA requirements||✓|
|Where do the experts come from?|
|IVD Notified Bodies||✓|
IVD clinical performance refers to the ability of an IVD device to accurately diagnose or predict the presence or absence of a specific medical condition or disease in patients. IVD clinical trials, with prospective or retrospective study designs are typically required to establish clinical performance.
This is a critical component of the regulatory approval process for IVD devices, as it demonstrates the device’s ability to produce reliable and accurate results, which is essential for ensuring patient safety and effective clinical decision-making.
IVD clinical performance is important because it demonstrates the device’s ability to produce reliable and accurate results, which is essential for ensuring patient safety and effective clinical decision-making.
Accurate and reliable diagnosis is critical for guiding patient treatment and management, and IVD devices play a key role in this process.
IVD studies evaluate several factors, including diagnostic sensitivity, diagnostic specificity, positive predictive value, negative predictive value, and others.
These studies typically involve testing the device in a large and diverse patient population, including those with and without the target medical condition or disease.
The main gap identified in IVD studies is the application of sources to demonstrate clinical performance. There is often a lack of clarity and consistency in the application of sources of clinical performance data, which can lead to confusion and inconsistencies in regulatory submissions.
Clinical performance data should be presented in a manner that is consistent with regulatory requirements, such as Annex XIII 2.3 of the IVDR. Clinical Performance studies are typically required unless the manufacturer can comfortably rely on other sources, including peer reviewed literature for example.
At MDx CRO, we cover the full IVD lifecycle, from patent to IVD clinical trials, commercialization and beyond. We understand the complexities involved in bringing a new diagnostic test to market, and our team of experts has the experience and knowledge to guide you through every stage of the process.
Whether you need help with market research, product development, medical writing, regulatory compliance, or post-market support, we’ve got you covered. Trust us to be your partner throughout the entire diagnostics lifecycle, helping you to bring innovative and effective solutions to patients and healthcare providers.
MED IVD HEALTHTECH S.L ha sido beneficiaria de la subvención de contratos de trabajo de la Comunidad de Madrid, cofinanciado por el Fondo Social Europeo dentro de la Ayuda a la Recuperación para la Cohesión y los Territorios de Europa (REACT-UE), a través del Programa Operativo Regional FSE, en el marco del Programa Impulso a la Contratación Estable de Jóvenes para la Recuperación Económica, gestionado por la Dirección General del Servicio Público de empleo de la Consejería de Economía, hacienda y empleo de la Comunidad de Madrid.
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