Bioanalytical Services


Small Molecule

The bioanalytical services group of ICON offers method development, assay validation, and specimen analysis using state-of-the-art mass spectrometry (LC/MS/MS and GC/MS ) as well as liquid and gas chromatography.

ICON’s dedicated method development teams have extensive experience developing and validating robust bioanalytical methods in blood, urine and tissue specimens to support pre-clinical and Phase I through Phase IV clinical trials. Validations of bioanalytical methods are performed in compliance with GLP and are patterned after the current FDA "Guidance for Industry - Bioanalytical Method Validation." With a standard-setting run repeat rate of less than 5%, we are able to generate timely and reliable results in keeping with our clients’ timelines.

Services Include:

  • Method Development & Validation
  • Support for Pre-Clinical Animal Studies
  • Support for Clinical Trials
    • Pharmacokinetic (PK) Analysis
    • Bioavailability Studies
    • Bioequivalence Studies
    • Drug Interaction Studies
  • Metabolite Identification & Screening
  • Hazardous Sample Laboratory for HIV & Hepatitis-B
  • Biomarkers
  • Dried Blood Spot Analysis

Large Molecule

The bioanalytical services group of ICON develops sensitive and specific GLP compliant immunoassays to support the research and development of macromolecules for PK, biomarkers and immunogenicity studies.

Assay development can be customised to meet client needs and direct, indirect, capture and competitive ELISA formats are available.

The platforms include absorbance, chemiluminescence and electrochemiluminescence using MSD technology or fluorescence using Gyros Workstations, or Protein Biochip Array Technology using the Randox Evidence. We also provide high throughput immunoassay support for drug development using assay formats developed internally or provided by the client.  Our facilities employ state-of-the-art automated liquid handling systems to increase accuracy and precision and decrease turnaround time.

Services Include:

  • Method Development & Validation
  • Support for Pre-Clinical Animal Studies
  • Support for Clinical Trials
  • PD/Biomarkers
  • Cell-based Bioassays
  • PK & Immunogenicity
    • Pegylated Proteins
    • Fusion Proteins
    • Peptides
    • Antibodies