LARGE VOLUME OF SAMPLES – Our team created a customized database and managed samples for a large 166-site Phase II study. More than 16,000 samples were collected during the course of the study, including placebo samples, of which ten percent were to be analyzed. CSL organized samples and blinded the sample ID to the analytical group.
CUSTOMIZED SAMPLE COLLECTION KITS – The CSL team coordinated a 32-site (US and Canada), 120 subject study where KCAS provided clinical sites with collection kits containing calibrated pipettes, pre-labeled and weighed sample tubes, processing/shipping instructions and all other shipping supplies.
SPECIAL NEEDS ASSAY – KCAS has a specialized assay to quantitate menstrual blood loss from feminine products. For these programs, KCAS supports complicated sample logistics and handling including, label design, inventory controls, lab manual, patient information cards, a customized database for sample tracking, data collection and reporting results, query generation to clinical sites and a web portal designed by our team for data export to the client’s statistician.
A MAZE OF LABS AND SAMPLES – A large 40-subject study, calling for plasma and urine collections, involved the process of transferring urine aliquots to eight test tubes that were pre-labeled for each time point. Four of the test tubes were precisely pipetted by the clinical site. The KCAS CSL team trained the clinical site and provided collection kits, labeled tubes, a lab manual, calibrated pipettes, shipping containers and labels. Furthermore, the project required shipping samples to multiple locations for storage and analysis.
PREVENTING POTENTIAL BIAS – While working on a blinded study, KCAS received samples from the clinical site that were unblinded. Since the CSL team is independent of the analytical teams at KCAS, they blinded the samples in house, keeping the analytical data safe from bias. That wasn’t the only obstacle KCAS encountered during this particular study. At the clinical site, important information was omitted on the sample tubes and paperwork. The KCAS CSL team traveled to the clinical site to assist in correcting the errors and salvaged as many samples as possible.
PREPARATION OF SAMPLES PRIOR TO ANALYSIS – While working with a local specialty lab, cell samples from an antibiotic study were drawn and immediately sent to KCAS for centrifugation and processing. It was required that the cell samples be collected under sterile conditions, split immediately, flash frozen in methanol-dry ice baths and stored at -70 degrees Celsius or below until shipped to the sponsor for analysis. KCAS prepared all of the collection tubes and labels, transported the specimens, documented inventory, prepared the sterile preservation solutions, prepared the samples and stored the samples until shipment for analysis.
UNUSUAL COLLECTION AND PROCESSING – A client was encountering complications with syringes used to dose patients with a degenerative muscle disease. The client was in need of determining why the syringes were not delivering the full dose of medication. In cooperation with the US Postal Service, KCAS developed a safe way for subjects to collect their used syringes and mail them directly to KCAS. Upon arrival at our facility, the syringes were photographed and the amount of drug remaining was documented. The syringes were then stored for further examination by the client. In the end, the work done by the KCAS CSL team was crucial in the client solving the drug delivery problem.