The time between purchase order and submission of the study report is usually 6 – 12 months depending on the complexity of the clinical performance study. Lead times for validation depend on the intended purpose of the product. If suitable sample donors are abundant, the sampling process is uncomplicated, and the required sample size is low, lead time will be short. In the case of a high number of donors with rare diseases are needed for a complicated sampling procedure, lead time will be long.
Cost requirements of a clinical performance study are usually 80,000 € – 350,000 €. The price is very much dependent on the intended purpose of the product. Factors that drive costs are, among others, required sample size, number of sample types, complexity of analysis (PCR is more expensive than a lateral flow test), number of different analyses, and deviation from diagnostic routine.
Our own services focus on clinical validations. To be able to provide a full-range service for the whole value-chain of IVD products, we collaborate with partner companies whose expertise fills our gaps. IVD product development and analytical performance studies are carried out by our partners from Future Diagnostics B.V. If required, we would be glad to establish a contact.
No. ICS only functions as a Contract Research Organization (CRO) for the planning, conduct, and evaluation of the clinical performance study. CE-certification can only be carried out by accredited notified bodies. Currently (September 2023), there are ten notified bodies designated under IVDR 2017/746: DEKRA Certification GmbH (Germany), DEKRA Certification B.V. (Netherlands), TÜV SÜD Product Service GmbH (Germany), TÜV Rheinland LGA Products GmbH (Germany), BSI Group The Netherlands B.V. (Netherlands), GMED SAS (France), National Standards Authority of Ireland (Ireland), MDC Medical Device Certification GmbH (Germany), 3EC International a.s. (Slovakia), and QMD Services GmbH (Austria). Please consider the individual scope of IVD-products that the individual notified bodies are accredited for.
The involvement of an ethics committee before the start of a study can only be skipped in very rare cases. This depends on the specifications of the product which is to be validated. Even in those cases, we strongly recommend the involvement of an ethics committee.
Yes, our study plans and study reports are designed to fulfil all regulatory requirements.
No. Communication with the notified body is done by the manufacturer or – in case of non-EU manufacturers – by the authorised representative. If you need an authorised representative, we recommend Qarad BV. If required, we would be glad to establish a contact.
Yes. Samples for clinical performance studies must fit precisely to the intended purpose of the validated product. We procure all samples in a project-specific manner and according to the study requirements.
Our study site and laboratory are not certified according to any official standard. In all cases where such standards are needed (e.g., because the intended purpose of the validated product requires it), we collaborate with external study sites that are fit for the purpose. This is a standard procedure; most clinical performance studies are conducted in external study sites due to the different individual requirements of IVD products.
This depends on the required sample specifications. Samples that cannot be collected in our own study site are collected in collaborating study sites. ICS profits from a dense network of collaborations to clinics, test centres, and physicians’ practices from all medical fields.