Kit Building: High Quality Kit Packing And Distribution

We understand it is of pivotal importance that a clinical trial sample taken from volunteers or patients in any phase of a clinical trial is treated with the utmost care. To guarantee sample integrity and support the investigator in isolating specimens, Cerba Research’s collection kits are highly customized, user-friendly, and promote high-quality data points. From documentation to deep freeze shipping without dry ice, our kits contain everything sites need to keep their samples moving, including native-language instructions.

Cerba Research also handles the entire lifecycle of sampling kits for virology clinical trials and gene therapy projects. We offer a professional kit labeling facility, a range of packaging solutions, generation of kit inserts and instruction leaflets, and full kit assembly. Our automation belt streamlines the kit-building process, reducing the need for manual labor, increasing production efficiency, and performing automated quality control, producing up to 700 kits a day.

We routinely distribute initial collection kits for clinical trials to clinical sites up to 10 days before the first patient’s first visit, and we fulfill resupply orders in real-time, as well as diagnostic kits. The facilities together can accommodate a total kit production and distribution of 800,000 kits annually.

Overview

• FDA Listed Sample Kits for POC
• IVD directive 97/78/CE and the new directive
• ISO 13485 certified kit production facility
• Annex IIa and IIb high risk, (notified body-involvement)
• Annex III (self-certifying)
• Customized visit specific sample collection kits for clinical trials for a wide range of specimen collection (blood, serum, plasma, urine, CSF, Biopsies, Saliva, DNA, PBMCs, etc.)
• Pre-labelled tubes and forms
• Kits to guarantee sample shipment at different temperatures, from ambient to cooled, frozen and liquid nitrogen