Bioanalytical CRO Excellence

Welcome to KCAS Bio, your global bioanalytical CRO partner with the expertise, capacity and flexibility sponsors require.

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Bioanalytical CRO expertise

KCAS Bio is a leading bioanalytical contract research organization (CRO) with a proven record of advancing drug development worldwide. We have supported more than 315 FDA-approved drugs, developed over 6,200 proprietary and non-proprietary assays, and successfully completed more than 20 FDA audits with no major findings.

As a top bioanalytical CRO lab, we continually invest in the latest instrumentation and combine this technical expertise with a consultative approach, ensuring our clients’ goals are achieved with confidence. Our teams also bring specialized expertise in advanced modalities, allowing us to support the evolving needs of modern drug development. By consistently benchmarking and optimizing our operations, we help scientific innovators and investors move forward with greater certainty.

With facilities across the US and Europe, along with a strategic alliance in Australia, we provide global sponsors with comprehensive services including bioanalytical, biomarker, immunogenicity, cellular and molecular assay capabilities, as well as clinical kitting and sample management.

Did you Know? We have Harmonized Spectral Flow Cytometry on a Global Scale!

KCAS Bio is the only bioanalytical laboratory with globally harmonized Cytek spectral flow cytometers, with sites in the US, EU and Australia.

More on Global Spectral Flow Cytometry

400 Years Of Combined Scientific Experience.5000 Proprietary and Non Proprietary Assays Developed to Date.65 PhDs on Staff25 FDA Audits45 Years in Service4 World Wide Locations

Global biomarker and bioanalytical CRO lab

KCAS Bio is an established bioanalytical CRO with over 45 years of experience. We understand the human and financial impact of drug development delays. Through our unique approach to capacity planning, we combine the right experts with the right instrumentation to keep development moving smoothly. Our clients consider us a reliable partner because we strive to minimize downtime, avoid delays, and keep lead times as short as possible.

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What our clients say

We consistently earn our clients’ trust based on our reputation for transparency, delivering error-free data and keeping our promises.

I want to thank you for yet another great job on a clinical project. From study’s initial contract, to PK kits, to validation and analyses, and ultimately, the final data, all was excellent as always. Happy to work with you all and I look forward to future studies.
VICE PRESIDENT, BIOPHARMACEUTICALS COMPANY
I want to express my appreciation for the professional care and extra effort of the KCAS Bio validation team. It is very evident that these team members truly care about their work and continuously strive towards excellence. I am very grateful to all of them for a thorough review of the document set before, during and after validation. My job of software validation specialist takes me to GLP labs around the world. So, I can say with confidence, that the work done at KCAS Bio was exceptionally well-documented with appropriate detail so anyone could easily understand the steps taken to validate the software.
SOFTWARE VALIDATION SPECIALIST, LAB EQUIPMENT PROVIDER
They developed and validated a pharmacokinetics small molecule method for support of my dog GLP toxicology study. The KCAS Bio work was high quality, on time, within budget, and they had great/open communication.
FOUNDER & CEO, BIOSCIENCE COMPANY
Global Validation of a Pan-Leukocyte Panel with Enumeration for Fresh Whole Blood​ Posters & Papers
Read article Global Validation of a Pan-Leukocyte Panel with Enumeration for Fresh Whole Blood​

Discover in this poster presented by Heather Evans, PhD, at ICCS 2025, our work on the “Global Validation of a Pan-Leukocyte Panel with Enumeration for Fresh Whole Blood​“. Validation Pan-Leukocyte Panel Whole Blood KCAS BioDownload If you have any questions about these services…

Podcast (The Weekly Bioanalysis) Eps #93: “Collaborating with Smaller, Scientific Partners to Accelerate Drug Development” Podcasts
Read article Podcast (The Weekly Bioanalysis) Eps #93: “Collaborating with Smaller, Scientific Partners to Accelerate Drug Development”

During episode #93 of The Weekly Bioanalysis, John and Dom welcome guest Chris Crean, founder/CEO of Xyzagen, who reflects on three decades in drug development and how the field has shifted from small molecules to today’s complex biologics, gene editing, and beyond. Chris explains how Xyzagen helps small, science-driven teams…

Podcast (The Conversational Flow) Eps #24: “Considerations for Flow Cytometry-based Cell Sorting” Podcasts
Read article Podcast (The Conversational Flow) Eps #24: “Considerations for Flow Cytometry-based Cell Sorting”

In this episode, Adam and Brian explored recent advances in cell sorting technology, focusing on image-activated approaches. Unlike traditional flow cytometry, which relies on voltage signals, these systems capture and analyze cell images in real time to guide sorting decisions, enabling new insights such as subcellular localization and cell-to-cell signaling.

Advancing great people and great science

We make nurturing new talent a strategic priority, so that teams are dynamic and constantly improving. We provide a supportive environment for continuous learning and training where you can become your best.

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Scientist Citations

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We've earned our reputation for delivering reliable, error-free data. We understand the importance of speed, flexibility, and consistency and only make promises we can keep.

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