card-3216_Biochemistry expert scientific with eyeglasses
Digital innovation

Driving operational improvements and quality of our services

card-3210_Laboratory technicians conduct a series of tests on a chemical analyzer
Science Innovation

Uniquely positioned to shape, validate, and deliver biomarker assessments that strive to improve patient outcomes across diverse Therapeutic Areas

card-3242_Scientist using tablet while colleagues working behind
Download our Corporate brochure

We are IQVIA Laboratories, a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions.

Download
card-3233_Laboratory scientist working at lab with micropipette, and 96 well plate
Corporate Video

Our commitment to customer success is embedded in every facet of our operations.

card-3210_Laboratory technicians conduct a series of tests on a chemical analyzer
Science Innovation

Uniquely positioned to shape, validate, and deliver biomarker assessments that strive to improve patient outcomes across diverse Therapeutic Areas

card-3216_Biochemistry expert scientific with eyeglasses
Digital Innovation

Driving operational improvements and quality of our services

English You are about to exit for another IQVIA country or region specific website Please be aware that the website you have requested is intended for the residents of a particular country or region, as noted on that site. Ok Open in new tab Search
hero bg-3256_scientist team meeting copy

Bioanalytical Services

Small and Large Molecule LC-MS

Liquid chromatography-mass spectrometry (LC-MS) is an essential technique for the modern bioanalyst. It has decades of precedence in small molecule drug development and regulated bioanalysis. As such, pharmacokinetic studies of small molecule drug candidates typically use LC-MS. Of late, the application of LC-MS has expanded to mid-sized drug modalities (e.g., peptides, small proteins, lipids and oligonucleotides) and large biotherapeutic drugs (e.g., antibodies and antibody-drug conjugates). We also now encounter LC-MS quantitative bioanalysis being applied to matrix-endogenous compounds including biomarker studies. With over 30 years’ experience serving the bioanalytical needs of our clients, IQVIA Laboratories has built operations that meet the needs of this rapidly changing drug development arena.

 

Our Project Managers and Principle Investigators have years of experience understanding the specific nuances of regulated bioanalysis that apply to your bioanalytical programs. With a stellar regulatory record, our LC-MS laboratories conduct bioanalysis to GLP/GCP regulations while in accordance with internationally recognized ICH M10 guidance for bioanalytical method validation.    

 

Whether you need support for an early preclinical study with 200 samples or a clinical Phase III or bioequivalence program with 30,000 samples and fast data turnaround, we have built our services to help you deliver to plan. 

 

Small Molecule Regulated Bioanalysis by LC-MS

Triple quadrupole mass spectrometry coupled to liquid chromatography is the mainstay of small molecule quantitative bioanalysis. IQVIA Laboratories’ bioanalytical laboratories have been leaders in the application of these LC-MS technology developments since 1993 and continue to serve our clients across the drug development spectrum as experts in the field.

 

We have over 60 modern triple quadrupole LC-MS systems dedicated to small molecule bioanalysis applications. These mass spectrometer instruments are matched with laboratory functions and operations that support PK/PD study bioanalytical work compliant with GLP/GCP regulations and global bioanalytical guidance from around the world.   

 

IQVIA Laboratories has extensive experience in de novo assay development, method transfers, method validation and in-study samples analysis supporting pre-clinical, non-clinical and clinical bioanalytical programs. From relatively simple small molecule drugs to peptide drugs, oligonucleotides, lipids and antibody conjugated payload moieties we apply our expertise to generating regulatory submittable bioanalytical data. Our laboratories are outfitted with a full suite of sample preparation equipment including robotic handling automation and 96-well plate standardization for biological fluid and tissue pre-treatment.

 

Small molecule LC-MS bioanalysis has continuously evolved since its inception and with techniques such as dried matrix microsampling, heavily multiplexed assays, biomarkers, new drug modalities and advances in drug formulation, IQVIA Laboratories continues to practice at the frontiers of bioanalysis with industry leading service and science.

 

Large Molecule Regulated Bioanalysis by LC-MS

Formed in 2008, the LC-MS Biologics team at IQVIA Laboratories utilizes both triple quadrupole and High Resolution Mass Spectrometry (HRMS) for biological analyte LC-MS quantitation.  With a fleet of 11 validated HRMS comprised of both Q ExactiveTM Orbitrap and Orbitrap ExplorisTM instruments, we lead the industry with HRMS capacity for regulated bioanalysis. 

 

With the increasing need for sensitive bioanalytical methods, we have a fleet of nano-flow liquid chromatography systems which when coupled to high resolution mass spectrometers provide ultimate sensitivity. Extensive HRMS and low flow chromatography capabilities along with automated bead-based immunoprecipitation techniques delivers unparalleled sensitivity and proven reproducibility in robust workflows. These advanced techniques and our depth of experience combine with a collaborative approach to solve your large molecule bioanalytical challenges.

Related Services

card-3229_test tubes for testing

Bioanalytical Services

Learn more
card-3215_People working at laboratory

Quantitative Assays for Peptides using LC-MS

Learn more
card-3215_People working at laboratory

Biotherapeutic Immunoassay Services

Learn more
card-3233_Laboratory scientist working at lab with micropipette, and 96 well plate

Immunoassay and Immunogenicity

Learn more
card-3275_Young scientist works in modern laboratory

Bioanalytical Immunoassay Services for Biosimilar Development

Learn more
card-3211_Scientist wearing safety glasses

Validated Assays

Learn more

Related Insights

Managing Informed Consent Samples from Clinical Trials

A set of best practices for the definition, tracking and management of allowable use attributes associated with samples collected in protocol based clinical trials

Biorepository and Specimen Management

Your biological specimens are irreplaceable assets – trust them with a proven partner

ADME Services

Accelerating your drug discovery, preclinical and clinical programs

IQVIA Laboratories Central Laboratory Services

Central laboratory solutions supporting clinical trials around the world

Helping you master your lab data

Improved oversight with your lab data now in full view

NASH and Liver Disease Capabilities

Nonalcoholic Fatty Liver Diseases & Non-alcoholic Steatohepatitis (NAFLD & NASH)

How COVID-19 Changed Clinical Trial Dynamics and Environment

Precision Medicine World Conference 2021 Virtual Presentation

Pediatric Initiative

Optimizing small blood volumes to prevent canceled tests in clinical trials for pediatric patients

Vaccine Laboratory Services

Test Menu

SARS-CoV-2 Vaccine Induced Antibody Profiles

Presented at World Vaccine Congress 2021

See All