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Services

KCAS Bioanalytical & Biomarker Services | kcasbio.com | contact us: info@kcasbio.com

To support our clients Research & Development programs including, IND-enabling preclinical and clinical studies, KCAS conducts non-GLP and GLP bioanalysis in a variety of tissues and matrices. With 35+ years of experience our team adds value to our clients programs by offering to ensure sample processing integrity, properly trained clinical sites and regulated long-term storage.

> Provide protocol guidance for sample processing and shipping instructions

> Work with sponsors and clinical sites to ensure a smooth chain of custody transition from clinic to KCAS

> Provide the pre-labeled collection containers or tubes, sample storage cryovials, shipping containers, and other supplies related to sample processing

> Design and validate a customized database for specialized sample collection needs

> Send trained technicians to the clinical site to handle sample processing and shipping to alleviate staffing concerns and ensure the proper care of samples that require delicate processing. > Monitor clinical sites for sample processing and shipping compliance, allowing the Clinical Research Associate (CRA) to concentrate on subject-related or patient-related procedures.

> Maintains a historical database of all clinical sites that have shipped samples. The database is used for tracking purposes and provides clients with feedback on the clinical site’s performance.

> Long-term storage of pharmacokinetic (PK) and toxicokinetic (TK) samples refrigerated at –20 ° C or –70° C.

> 7 Freezers with 140 ft3 capacity for ultra-cold –70° C sample storage

> 1,540 ft3 walk-in-freezer for –20 ° C sample storage

> Triple-redundant temperature records are traceable to National Institute of Standards and Technology (NIST) standards

> All equipment and freezers are monitored by an external vendor and temperature deviations trigger an audible alarm and phone tree notification system.

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Sample Collection Instructions

KCAS Study Services

Archive Sample Storage

Bioanalytical & Biomarker Services

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 study, including placebo samples, of which, 10% were to be analyzed. CSL organized samples and blinded the sample ID to the analytical group.

The CSL team coordinated a 32-site (US & 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.

KCAS has a specialized assay to quantitate menstrual blood loss from feminine hygiene products. For these programs, KCAS supports complicated sample logistics and handling, including label design, inventory controls, lab manual, patient information cards, and a customized database for sample tracking, data collection reporting results and query generation to clinical sites. Furthermore, a web portal is designed by our team for data export to the client’s statistician.

A large 40-subject study that called 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. 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 multiplelocations for storage and analysis.

KCAS was working on a blinded study and 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 CSL team traveled to the clinical site to assist in correcting the errors and salvaged as many samples as possible

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 were collected under sterile conditions, split immediately, flash frozen in methanol-dry ice baths and stored at -70o C 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 samples and stored the samples until shipment for analysis.

A client encountered complications with syringesused 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 our CSL team was crucial in the client solving the drug-delivery problem.

CSL Case StudiesPreventing Potential Bias

Customized Sample Collection Kits

Large Sample Volume

A Maze of Labs & Samples

Unusual Collection & Processing

Preparation of Samples Prior to Analysis

Special Needs Assay

KCAS Bioanalytical & Biomarker Services | kcasbio.com | contact us: info@kcasbio.com

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Bioanalytical & Biomarker Services