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Bioanalytical Services & Solutions

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.

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Small molecule

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?

Talk to one of our experts

Large molecule

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.

Do you have a large molecule project?

Talk to a large molecule expert

Genotyping

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.

Are you interested in our PGx method list?

Learn more about genotyping

Biomarkers

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?

Partner with our bioanalytical lab

PK/PD Data Analysis

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.

Looking for the best in industry support?

Talk to our data analysis team

Phases

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.

  • Method Transfer
  • Assay Creation
  • Sample Analysis
  • PK Data Analysis
  • Kit Production
  • Off-the-shelf Assays

WorldwideEdge™

See how WorldwideEdge™ can help you succeed

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. 

Tour our bioanalytical lab

Our Dedicated Team

Jayaprakash (JP) Kotha, MBBS, Ph.D, ASCP (SH)

Vice President, Bioanalytical Laboratory

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.

Meet Dr. Kotha

Leimin (Perry) Fan, PhD

Associate Director, Method Development

Jason Hamilton, PhD

Associate Director, Method Validation

Jeffrey G. Stark, PhD

Senior Director, Head of Pharmacokinetics

Tom Zhang, PhD

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.”

Early Phase: Preclinical Biopharmaceutical Company Senior Vice President of DMPK

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.”

Clinical Operations Early Phase Small Biopharma (North America)

“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.”

– CEO and Head of Clinical Development Early Phase: Small Biotech Customer

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.”

– Head of Regulatory Affairs Early Phase: Small Biopharma Customer

Validated Assays

Worldwide Clinical Trials has access to more than 2,000 validated assays.

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Scientific Expertise

Revolutionizing Bioanalysis through Automation
A CRO partner for your biomarker development strategy