Some clients need more than just the best bioanalytical sample analysis. To support our clients Research and Development programs, including IND-enabling preclinical and clinical studies, KCAS conducts non-GLP and GLP bioanalysis in a variety of tissues and matrices. With more than 35 years of experience, our expert team adds value to each of our pharma, biotech and CRO clients with a wide range of offerings to ensure sample processing integrity, properly trained clinical sites and regulated long-term sample storage.
Sample Collection Instructions
- Protocol guidance for sample processing and shipping instructions
- Work with Sponsors and clinical sites to insure a smooth chain of custody transition from clinic to KCAS
- Provide pre-labeled collection containers or tubes, pre-labeled sample storage cryovials, shipping containers and other supplies related to sample processing
- Design and validate a customized database for specialized sample collection needs
On-Site Study Services
- Send trained technicians to clinical site to handle sample processing and shipping to alleviate staffing concerns and ensure the proper care of samples requiring delicate processing.
- Monitor clinical sites for sample processing and shipping compliance, allowing the Clinical Research Associate (CRA) to concentrate on subject or patient-related procedures.
- For tracking purposes and to provide clients with feedback on clinical site performance, KCAS maintains a historical database of all clinical sites that have shipped samples.
Archive Sample Storage
Long term storage of archive pharmacokinetic (PK) and toxicokinetic (TK) samples refrigerated at -20°C or -70°C
- Seven 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 standards
- All equipment and freezers are monitored by an external vendor, temperature deviations trigger an audible alarm and phone tree notification system
KCAS Virtual Lab Manual
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