How do central lab services work?

Quality cental lab services require more than assembling kits, it demands standardized processes, regulatory rigor, and end-to-end traceability. KCAS Bio’s central lab services are designed to support the operational and scientific needs of complex, multi-site studies.

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Central lab and kitting process overview

From the initial design of custom kits tailored to your protocol, through global distribution with strict temperature control and chain-of-custody oversight, to meticulous sample processing and integrated data management, every step is engineered for accuracy and traceability.

  • Kit Design & Assembly
    Custom kits are developed based on your protocol and include labeled tubes, collection materials, shipping documentation, and detailed instructions.
  • Distribution & Logistics
    Kits are shipped globally with temperature control, customs documentation, and chain-of-custody tracking to ensure timely delivery and compliance.
  • Sample Receipt & Processing
    Biological samples arrive at our central lab for accessioning, aliquoting, and processing according to your study’s requirements. All data is recorded and reconciled through our integrated LIMS and Barcode Sample Tracking System.
  • Data Management & Reporting
    Every sample is barcoded and digitally tracked from collection through analysis. Data is formatted and delivered per regulatory and sponsor specifications.

From Design to Data: A Detailed Look at Our Process

At KCAS Bio, our Central Lab Services are built to streamline every stage of specimen management, from kit design through data reporting. While the section above provides a high-level overview, the following content offers a detailed breakdown of each step in the process. With tools, training, and support tailored for clinical trial sites, our team ensures consistent, high-quality sample collection and handling.

Step 1: Kit Design & Assembly

Our team of experts reviews your clinical protocol and designs custom collection manuals and kits to guide site staff through every step of the process. Our collaborative approach allows us to truly understand each client’s needs, delivering laboratory manuals and kits that drive confidence through comprehensive, precise, and error-free specimen collection. Focusing on practical, intuitive instructions tailored for real-world use allows us to transform complex requirements into clear, reliable, user-friendly collection manuals.

Step 2: Distribution & Site Support

KCAS Bio offers flexibility and speed when it comes to distribution of kits to trial sites. Sending kits on a predetermined schedule or an on-demand basis, our team supports a variety of options for kit ordering and tracking. We also offer on-site demonstrations, as well as on-demand, pre-recorded, or written training materials for use of kits and manuals. Providing training directly to site staff helps ensure proper use of kit materials, as well as consistent collection, storage, and shipment records, which supports critical chain-of-custody documentation.

Step 3: Repository Storage & Tracking

KCAS Bio’s biorepository capabilities include all temperature conditions, including ambient, refrigerated, frozen, ultra-low, and liquid nitrogen storage. We utilize the Rees Centron Presidio environmental monitoring system, as well as a rotating 24/7 on-call schedule for surveillance of cold storage conditions. KCAS Bio Central Lab Services support scheduled or on-demand sample storage inventory reporting, batch shipment, and reconciliation services.

Step 4: Data Access & Reporting

KCAS Bio utilizes the Watson LIMS system to track and record sample shipments, conditions, and location within both our biorepository service and our analytical services. This approach allows for seamless transfer of samples for internal or external analysis, and provides comprehensive, regulatory-compliant sample chain-of-custody documentation for all samples.

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