ICS – being a specialist department of in.vent Diagnostica GmbH – has access to clinical samples of highest quality and customisability. in.vent Diagnostica has 25 years of experience in the field of human biomaterial procurement and fully supplies our study service with top priority.
We are not only a biobank, having over 300,000 samples with defined clinical background in stock. We are also capable of actively sourcing samples with exact specifications, which is an essential prerequisite for a successful clinical performance study. All our collections are approved by institutional review boards and governmental authorities.
Benefiting from our company-owned study centre, we can freely adapt processes according to your needs. We have complete control over pre-analytical conditions, entailing maximum reliability of clinical data.
Our study centre is optimised for collection of blood, plasma, serum, urine, stool, and respiratory swabs, covering the most common sample types in in vitro diagnostics.
A study site must be fitting for the intended purpose of the device. In case our company-owned study centre is not an optimal choice for a specific device, we can rely on our extensive global network of physicians, medical practices, and hospitals. All our collaborations are based on a service-level agreement and bound to confidentiality. Theses international partnerships allow our study services to cover IVDs from all medical fields, including medical indications that can barely be found in the EU.
IVDR article 57.2 states: „Where appropriate, performance studies shall be performed in circumstances similar to the normal conditions of use of the device.“ For the majority of IVDs, this means that prospective sample sourcing with the actual target population of the device is legally required. Our procurement experts will design sampling projects that strictly follow the intended purpose of your device, even collaborations with new clinical partners, if necessary.
Whenever possible, we recommend using leftover or residual samples for diagnostic studies, as this is by far the most economical way to generate clinical data. We have a team of experts in place solely for the procurement of leftover samples so that you can rely on verifiable background information and appropriate storage and transport conditions at a very competitive price.