Central Lab and Sample Kitting Services
KCAS Bio’s Central Lab Services delivers custom, protocol-driven kits and documentation to ensure consistent sample collection, handling, and storage across clinical and preclinical studies. From laboratory manual and collection kit design to secure biorepository management, our services reduce variability, improve data quality, and maintain compliance across every stage of your trial.
Your bioanalytical partner for central lab services success
Custom Kit Assembly for Every Trial Phase – Custom kit design from routine sample collection to specialized requirements (e.g., PAX gene, TruCulture) for all phases of clinical trials and a variety of collection types, from simple blood draws to complex muscle biopsies. Each kit includes labeled components, barcoded tracking, and any custom materials needed. Lab manuals provide clear instructions for clinical site staff.
Comprehensive Manuals and Training – Study-specific collection manuals ensure procedures are followed consistently, reducing site variability and protocol deviations. We offer full support during investigator meetings to present the kits and provide in-depth training (including options for in-person, remote, or pre-recorded videos) to development teams, ensuring that every aspect of kit usage is fully understood.
Global Support – Comprehensive shipping and logistics support for clinical trials worldwide. With experience shipping to over 800 sites worldwide, we simplify complex logistics for you. From managing international documentation and courier partnerships to ensuring efficient site deliveries and secure sample storage, our team streamlines the movement of study materials worldwide.
Integrated Biorepository – Secure, GxP-compliant storage for short- and long-term sample preservation. Inventory is fully tracked and audit-ready with Watson LIMS integration.
Regulatory Alignment – Capability to align with the regulatory framework required for each study, whether GLP, GCP, or other sponsor-specified guidelines. Processes can be performed under GLP/GCP standards and aligned with FDA, EMA, and ICH guidelines.
What are central lab services?
Central lab services are critical components of clinical trial operations, ensuring consistent collection, processing, and tracking of biological samples across sites and geographies. KCAS Bio’s offerings are designed to reduce variability and improve data quality and efficiency by standardizing collection materials and procedures while complying with client specific regulatory guidelines.
- Custom Clinical Kits Design: Developing tailored clinical kits for all phases of clinical trials, both for human and animal drug development worldwide.
- Specialized Sample Collection Supplies: Providing specialty items needed for non-routine matrices, including custom lab manuals and comprehensive sample collection kits. No limitations to kit components, offering all commercially available materials requested.
- Rapid Kit Turnaround: Ensuring quick preparation and shipping of clinical sample kits, with the capability to ship within five days, depending on supply availability.
- Global Shipping and Logistics: Handling logistics for over 100 clinical trials annually, including permits and import documentation for international shipments.
- Integrated Sample Tracking: Utilizing integrated systems to streamline sample submission, generating pre-populated manifests and sample labels, with sample receipt and tracking fully integrated with Watson LIMS.
- Sample Processing and Storage: Managing sample processing, shipping, and storage, including specialized tubes such as PaxGene, cfBCT, and others.
- Bio-Repository Services: Maintaining bio-repositories with storage options at -20ºC, -70/80ºC, and in liquid nitrogen, ensuring sample integrity for long-term preservation.
Streamline your study with our expert central lab services.
Applications of central lab services in drug development
Phases of Drug Development
Discovery – Early feasibility studies supported through sample standardization.
Preclinical Research – Consistent matrices enable comparative studies and method development.
Clinical Trials – GCP workflows supporting complex, multi-arm, global studies. Sample integrity and reconciliation data aligned with FDA/EMA expectations.
KCAS Bio provides support for pre-clinical studies, as well as Phases I-IV, with decades of experience servicing clinical trials from single-site, short-term trials to multi-year, global studies across dozens of sites worldwide.
Capabilities of our central lab services
KCAS Bio Central Lab Services simplify complex clinical sample operations, offering flexible services that adapt to the unique needs of each study. With experience managing multi-site trials and global logistics, our team ensures a reliable, streamlined processes from start to finish.
Custom Clinical Kit Design & Assembly
Tailored kit solutions for all phases of clinical trials, including routine sample collection and specialized biomarker studies.
Regulatory-Compliant Kitting Services
Flexible adherence to GLP, GCP, or sponsor-specific regulatory guidelines to meet global clinical trial requirements.
Global Logistics & Inventory Management
Efficient international shipping, permits, documentation, and courier coordination, combined with proactive inventory planning to prevent shortages.
Multi-Site Study Support
Centralized kit distribution and sample tracking for multi-site clinical trials, ensuring standardized procedures and consistent data quality.
Barcoding & Labeling
Provides accurate sample identification and enhanced traceability across all study sites.
Temperature-Controlled Logistics
Cold chain management, including refrigerated and frozen shipping solutions, to maintain sample integrity from collection to analysis.
Scalable Clinical Trial Support
Flexible services designed to accommodate studies of any size, from early-phase exploratory trials to large-scale global programs.
Expert Scientific Consultation
Guidance on sample collection strategies, assay compatibility, and workflow optimization to improve study outcomes.
Data Integration & Reporting
Secure, accurate, and timely reporting of sample tracking and study metrics to support sponsor decision-making.
Technology and instrumentation for central lab services
Platforms & Technologies Used
- Frozen, Refrigerated and Ambient Logistics Options: Dedicated, access-controlled lab spaces and storage units for secure, temperature-stable bio-storage. Monitored domestic and premium courier service options for all shipping conditions, including liquid nitrogen.
- Barcoded Sample Tracking: Chain-of-custody accuracy from dispatch to archive.
- Watson LIMS: Real-time sample tracking, inventory management and data reporting.
Why work with KCAS Bio?
One-Stop Lab Partner
Kitting, logistics, and bioanalysis all under one roof.
Simplified Site Compliance
Clear, user-friendly manuals reduce training burden and site variability.
Complex Materials & Matrices
Experience identifying and sourcing specialty items needed for non-routine matrices and collections.
Global Shipping & Logistics
Infrastructure and expertise to support complex, multi-site studies.
Regulatory Compliance
Adherence to client-specific regulatory requirements, including GLP and GCP, for workflows and documentation.
Rapid Turnaround Times
Streamlined processes ensure timely support and reduced delays in sample collection and analysis.
Central lab services FAQs
What phases of drug development do you support?
KCAS Bio supports discovery, pre-clinical, and clinical trials Phases I-IV.
What size trials do you support?
KCAS Bio supports all sizes of trial, providing best-in-class service, rapid and efficient one-on-one collaboration and support, and fully customized materials for all trial sizes. We have decades of experience supporting trials and companies of all sizes.
What types of kits do you provide?
We design collection kits for blood, plasma, serum, urine, swabs, and other matrices, tailored to your protocol. Whether routine or highly customized, KCAS Bio provides expertise and collaboration to design and supply the perfect kit for every collection type.
Are there limitations to the supplies that are available for kits?
No, KCAS Bio does not require specific supplies to be selected from a set inventory or stock list. We will stock and supply any materials that we are able to obtain commercially.
Do you provide training for use of collection kits?
We are able to provide on-site training at trial sites, remote training sessions, and written or pre-recorded training materials for distribution to users.
Can you help me design a collection manual?
Yes, KCAS Bio has a library of templated, fully customizable laboratory manuals to choose from, and we provide comprehensive collaboration and expertise to ensure the instructions provided support proper collection techniques.
I only need a manual / I only need kits – can you provide one without the other?
Yes, KCAS Bio gladly partners with clients for manual-only or kit-only contracts, providing best-in-class service, regardless of the scope of work.
How do you manage collection manual distribution?
Manuals are designed to study specifications, with collaborative, client-driven updates and finalization. Version-controlled documents are distributed to trial sites at the client’s direction.
Do you offer sample inventory reconciliation services?
Yes, KCAS Bio provides sample reconciliation on a scheduled basis, working with a client-specified cadence for transmittals, and also offers ad-hoc support throughout your trial.
How do you manage repository storage?
Our biorepository uses validated, monitored storage systems with Watson LIMS barcode integration for complete chain-of-custody.
What temperatures are available for biorepository storage and distribubution?
We offer ambient (~15 – 25°C), refrigerated (2 – 8°C), frozen (-20 ± 5°C), ultra-low (-70/-80 ± 10°C), and LN2 (-196°C) storage and logistics options.
What compliance guidelines do you follow?
We align with the sponsor specified guidelines. Our capabilities include FDA, EMA, and ICH GCP regulations.
Additional resources
Blogs
From initial receipt to final disposition, sample integrity, traceability, and compliance are the foundation of our bioanalytical operations. We’re taking you behind the scenes to follow the journey of a sample through our facility. Here’s a detailed look at each stage in the lifecycle of a study sample at KCAS…
Blogs
Clinical sample kitting plays a vital role in drug development projects. It requires meticulous attention to detail and the experience necessary to ensure that each kit is crafted according to precise specifications. A well-organized clinical kit can be the difference between smooth operations and costly delays. At KCAS Bio, we…
Blogs
The age of cell and gene therapies (CGTs) is upon us! It has been a long road to get to this time. The first gene therapy trial on humans was performed in 1990 by researchers at the National Institutes of Health. The first FDA approved CGT came in 2017. One…
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