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Kit Building

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

Reach out to our kit building team and see how we can help advance your clinical research