Clinical Sample Logistics & Long-Term Storage

1. ClinicalSampleLogistics&Long-TermStorage
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.
ClinicalSampleLogistics&Long-TermStorage
Sample Collection Instructions
KCAS Study Services
Archive Sample Storage
Bioanalytical & Biomarker Services

2. 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 multiple
locations 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 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 our CSL team was crucial in the client
solving the drug-delivery problem.
CSL Case Studies
Preventing 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
ClinicalSampleLogistics&Long-TermStorageClinicalSampleLogistics&Long-TermStorage
Bioanalytical & Biomarker Services