Bioanalytical Services & Solutions

Helping your drug development journey progress with our state-of-the-art laboratory. 

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. 

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

Long history of experience

We have decades of experience in developing and validating bioanalytical assays in support of GLP and clinical studies. 

Collaborative network

Our bioanalytical services are supported by the collaboration of multiple teams, including method transfer, assay development, assay validation, sample testing, and sample management. 

End-to-End Bioanalytical Services

In addition to assay services, our lab assists with critical reagent generation, labeling and characterization, TK/PK data analysis, and report preparation. 

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Laboratory in Austin, TX

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BioA Right First Time

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Proprietary methods available 

Services

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Small Molecule

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.  

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Large Molecule

We offer a comprehensive suite of services, including method development, transfer, qualification, validation, and sample analysis to cater 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. 

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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.

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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.

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PK/PD Data Analysis

Our PK/PD Data Analysis delivers expert support across a wide array of studies, including Bioequivalence (BE)/Bioavailability (BA), ANDA, 505(b)(2) submissions, new drug formulations, and early phase trials like FIH and Ascending Dose studies. Specializing in areas such as interim analysis, hepatic/renal impairment, drug-drug interactions, and mass balance (AME) assessments, we use advanced non-compartmental analysis to offer essential pharmacodynamic insights. Our comprehensive services span from study design and protocol development to the execution of statistical analysis plans, ensuring precise and insightful data interpretation to streamline your drug development process. 

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Total Lab Automation

Our strong focus on science and automation implementation in our bioanalytical services makes us a unique partner. Our lab includes a Total Lab Automation system, built by integrating liquid handling, microwell plate shaking, plate incubation, plate washing, and plate reading. This automation platform allows us to analyze thousands of samples per month with excellent bioanalytical quality. 

Our Experts

Jayaprakash (JP) Kotha, MBBS, PhD, ASCP (SH)

Vice President, Bioanalytical Laboratory

Tom Zhang, PhD

Chief Scientific Officer, Large Molecule Bioanalysis

Leimin (Perry) Fan, PhD

Associate Director, Method Development

Jason Hamilton, PhD

Associate Director, Method Validation

Jeffrey G. Stark, PhD

Senior Director, Head of Pharmacokinetics

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.”

Early Phase Small Biopharma (North America) Clinical Operations

“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.”

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

“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

Awards

On May 1st, Industry Standard Research (ISR) announced the 2024 Leadership Awards, recognizing Phase 2/3 CROs for comprehensive excellence across their capabilities, compatibility, expertise, quality, and reliability.

In 2023, Worldwide Clinical Trials was named Most Innovative Clinical Research Organization (CRO) by the Triangle Business Journal (TBJ). This awards program celebrates the achievements of individuals and companies making critical advancements in pharmaceuticals, biotech, ag tech, and beyond, in the Triangle region of North Carolina.

Worldwide Clinical Trials, Inc., (Worldwide) the industry’s leading global, midsize, full-service contract research organization (CRO), has been recognized for excellence and honored in five categories in the 2022 CRO Leadership Awards, based on primary market research from Industry Standard Research (ISR) Reports and presented by Clinical Leader and Life Science Leader magazines. This marks the ninth consecutive year that Worldwide has been recognized as a high-performing CRO based on direct survey feedback from pharmaceutical and biotech professionals.

Over 80% of respondents agreed that midsize CROs, such as Worldwide, provide a strong cultural fit while being able to pivot quickly based on changing customer needs.

Read the full report here