Streamline your discovery and regulated bioanalysis with our comprehensive services, catering to a broad spectrum of modalities. Make informed decisions, faster, with the Bioanalytical Lab at Worldwide Clinical Trials.
With a robust menu of 600 LC-MS/MS Worldwide Validated Methods and 1500 Total Methods, we provide assays that meet required sensitivity levels, including low pg/mL lower limits of quantification (LLOQs), using stable isotope-labeled internal standards for precise quantitation. Our experience extends to validating analytes in plasma, serum, and cerebrospinal fluid (CSF), underpinning our comprehensive support for First-in-Human (FIH) Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies.
Are you interested in our Assay list or do you have a small molecule project?
We offer a comprehensive suite of services including method development, transfer, qualification, validation, and sample analysis catering to a wide range of biologics modalities—monoclonal antibodies, antibody-drug conjugates, bispecific antibodies, fusion proteins, enzymes, oligonucleotides, and gene therapies. As a one-stop solution, we provide everything from reagent generation, labeling, and characterization to assay and sample management, logistic support, and data analysis, ensuring a seamless and efficient process for your large molecule projects.
Our Pharmacogenomics (PGx) services are tailored to understand the impact of genetic differences on individual drug responses. By predicting drug safety, optimizing dosages, and improving efficacy, our PGx testing supports successful clinical trials and informed decision-making. Whether you’re developing small molecule drugs or exploring future applications for large molecules, our team can guide you through selecting the appropriate PGx panels and advise on sample collection for pivotal insights.
Our laboratory is at the forefront of protein biomarker assay and sample analysis, supporting both discovery and GCLP biomarker studies. From biomarker identification and platform selection to assay development, assay validation, and PD data analysis, we offer a seamless integration of services. In collaboration with worldwide clinical units, our one-stop service extends to meeting the diverse biomarker needs within clinical trials, encompassing risk/safety, diagnostic, predictive, prognostic, and PD/response biomarkers.
Do you have a discovery or GCLP biomarker project?
Our experienced team can deliver comprehensive support for a broad spectrum of studies, including Bioequivalence/Bioavailability, ANDA, 505(b)(2) submissions, new formulations/routes of administration, and early phase trials such as First-in-Human (FIH), Single and Multiple Ascending Dose (SAD/MAD) studies. Specializing in interim analysis, hepatic/renal impairment studies, drug-drug interactions, and mass balance (AME) assessments, we provide critical insights for pharmacodynamic evaluations using non-compartmental analysis techniques (e.g., EMax, Tmax, AUEC). From initial study design and protocol development to the intricate assessment of bioanalytical assay ranges, our team expertly crafts statistical analysis plans, conducts detailed statistical analyses, and interprets data to empower your drug development with precision and insight.
Our bioanalytical lab is equipped to support your project at any stage, from discovery through pre-clinical to clinical phases, ensuring seamless progression with tailored expertise and cutting-edge technology for every step of your drug development journey.
Discovery
Pre-clinical
Clinical
Modalities
Our versatile bioanalytical services are designed to support a wide range of project modalities, encompassing large molecules like proteins, monoclonal antibodies, and fusion proteins, as well as small molecules and advanced therapeutics such as oligonucleotides and peptides. With our comprehensive expertise, we provide tailored analytical solutions across all stages of drug development, ensuring your project’s success regardless of the molecule type.
Large Molecules
Small Molecules
Oligonucleotides/Peptides
Services
Our state-of-the-art bioanalytical lab in Austin, Texas, is ready to provide you with the bioanalytical support you need with capabilities in small molecule and large molecule, including PK, immunogenicity, and biomarkers.
Pharmacokinetics
Pharmacodynamics
Immunogenicity
PD/Biomarkers
Genotyping
Customized Service (Reagent, Labeling)
Protein binding
Capabilities
We are here to help progress your drug development journey with our state-of-the-art bioanalytical capabilities. From precise method transfer and innovative assay creation to comprehensive sample analysis, we offer a suite of solutions to accelerate your project.
You are always looking to make improvements in science, and we are too.
Discover how our commitment to continuous improvement can bring exceptional value to your bioanalytical and clinical programs.
Techniques and Platforms
Techniques
Ligand Binding Assays
Mass Spectometry
Instrumentation
Quantstudio TM 3 Real-Time PCR System
MSD
LC/MS
Spectramax
Microlab Star
Orbitrap Hi-Res Mass Spec Plate Readers
Liquid Scintillation Counter
Oxidizer to support radiolabeled AME studies
Total Lab Automation
STAR Pipetting Module
Microplate Washer
MSD QuickPlex SQ 120 Imager
Incubator Shakers
Find what you’re looking for in a bioanalytical lab partner.
Our 60,000 sq. ft. facility in Austin, Tx, coupled with our proven history of providing timely, reliable bioanalytical services, is further enhanced with fast access to industry-leading experts to consult and optimize the delivery of the data you need to make informed decisions, faster.
Jayaprakash (JP) Kotha, Vice President, Bioanalytical Laboratory, leads lab operations and all activities in Worldwide Clinical Trials’ Bioanalytical Center of Excellence, located in Austin, Texas.
Chief Scientific Officer, Large Molecule Bioanalysis
Client Testimonials
Hear from our past customers about their experience with Worldwide
“I wanted to thank you once again for making sure all the study samples got analyzed in time, and also for staying so late last evening and managing to upload the final unblinded data for our study to meet the deadline. Really appreciate how professionally you handled all the challenges that came your way.
Generating and successfully sharing high-quality data is what the Worldwide-Eidos partnership is all about.”
I like that [Worldwide Clinical Trials] has bioanalytical services as part of their offering, because that’s something that’s often carved out…not every CRO has that expertise.”
“I think that what differentiates [Worldwide Clinical Trials] from other CROs is how efficient they operate, how responsive they resolve or do their issue-resolution. Those are the things that I can think of immediately that make me like to work with midsized CROs.”
I thought very highly of Worldwide Clinical Trials. I thought they were a good, solid CRO and certainly would have them included in any upcoming clinical development work.”
Validated Assays
Worldwide Clinical Trials has access to more than 2,000 validated assays.
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