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.

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

Discover how our commitment to continuous improvement can bring exceptional value to your bioanalytical and clinical programs.

Techniques and Platforms

  • 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 
  • STAR Pipetting Module
  • Microplate Washer
  • MSD QuickPlex SQ 120 Imager
  • Incubator Shakers 

Find what you’re looking for in a bioanalytical lab partner.

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.

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