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Biological Samples Sourcing
Meeting the requirements of IVD assay development
The development and validation of in vitro diagnostic devices and assays rely on rigorously selected human biological resources: representative samples, associated clinical data, and matrices compatible with your analytical needs.
These high-quality biological samples are needed throughout the test development process: to define its performance (sensitivity, specificity), verify its reliability in real-world conditions, build a solid regulatory dossier, and, once the test is on the market, ensure post-market surveillance in accordance with the European CE-IVDR regulation and FDA regulatory requirements.
Developing a new diagnostics tool is complex ; sourcing biospecimens adds another layer of competencies to the project management team. We identified multiple criteria that can make the project at risk:
-a large set of samples, sometimes several hundreds, to make the test statistically reliable
-a set of negative control, for healthy donors, which is sometimes harder to find that from patients
-access to extensive clinical data, anonymized or pseudonymized
-specific collection requirements, such as plasma tubes, to match the technical requirements of the assay
-budget limitations, sometimes difficult to put specific samples collections in place
Labtoo: Your Partner in Biospecimen Sourcing for IVD
With over 8 years of experience, Labtoo has already supported dozens of IVD assay development projects.
We work with you to define precise specifications, then mobilize our network of healthcare facilities, collection centers, specialized CROs, and biobanks to quickly identify the biological resources best suited to your needs.
Whether you need positive or negative samples for your IVD tests, specific matrices (serum, plasma, saliva, swabs, etc.), or clinically characterized samples according to a defined protocol, we identify the most relevant suppliers and coordinate the entire process, with traceability, regulatory compliance, and adherence to deadlines.
When you outsource the sourcing to Labtoo, you outsource the complete process, from defining the requirements to contracting with clinical sites. Our team of scientists work relentlessly so that you know that your project is in good hands.
Are you looking for biological samples for your IVD assay development project?
Why choose Labtoo for your Biospecimen sourcing?
| Our Engagements | What you get |
|---|---|
| Saving your time and resources | We manage partner search, logistics, and contracting so you can focus on science |
| Comply with regulatory requirements | We deliver all necessary ethics docs (ICF, approvals, authorizations). You may ask to use your own informed consent form (ICF). |
| Unlock access to rare and complex samples | We work with a specialized network to access your hard-to-find samples, whether the pathology is rare, the type of sampling is complex, a matching set is required, or all of the above. |
| Offer proactive project management | We keep you informed in real time about technical feasibility, resource availability, and any changes that may need to be considered, based on feedback from clinicians. |
Looking for biospecimens for your next IVD project?
We help you find the right samples, faster, securely, and compliantly.
Contact our team to discuss your project.
