The success of any clinical trial or cohort study begins at the point of collection. A streamlined collection process can help ensure the quality of biological samples or cells and establish a robust information foundation. Our kit production services allow our customers to focus on their clinical trials or cohort studies, and the patients enrolled in them, by standardizing every aspect of sample handling, from collection through administration or analysis. We design and assemble kits containing everything technicians need to collect and retrieve a specimen, or administer treatment for investigational use in clinical trials, according to best practices.
Our kit production operations can design complex, customized kits with clinical and non-clinical supplies at any temperature, including cryogenic. To maximize the value of your clinical trial, we will help you design project-specific kits for the pre-manufacture collection of biological samples, investigative site preparation and subject administration as well as post- administration sample collection.
Oftentimes in clinical trials, cell-based therapies require complex preparation for administration. Great care must be taken to create a robust system that securely pairs the patient to the dose. Administration kits, used in conjunction with training personnel, can help standardize the preparation and administration procedures.
On average, 13% of samples are contaminated during collection. Kits can be used to mitigate this risk and standardize the collection process, which is a major factor in controlling pre-analytical variability. Collection kits not only assist in controlling variability, but can also serve as an ideal starting point for data collection.
Important Questions for Effective Sample or Cell Collection
- How will the biosamples or cells be collected to preserve their molecular integrity?
- How many biosamples or cells will be collected for the clinical trial or cohort study?
- How many “collectors” and locations will be involved?
- How long will the biosamples or cells have to be preserved?
- How and where will the biosamples or cells be stored?
- How will the data associated with the collected biosamples or cells be managed?