Clinical Lab Services
With laboratory based research at its core, our Lab Services division has over 20 years of experience performing testing for our quarantine studies and for many types of client contracted field based studies; including preclinical through late phase clinical trials.
Our scientists have extensive experience in the areas of virology, immunology and molecular biology. Our work includes assay development, transfer and optimisation across the immunological, molecular and cell based assay platforms, including offering extensive options in sample matrix testing and specialty biomarker assays. Utilising hVIVO lab services from late pre-clinical through late stage clinical studies provides clients with the benefit of consistent laboratory analysis through their entire program. This reduces analytical variability and provides cleaner data and improved bioanalysis for key changes.
hVIVO has designed their lab services to provide necessary services and support from small pre-clinical studies through to large, global Phase 3 studies.
Our laboratories are audited by MHRA for GCP (good clinical practice) and GCLP (good clinical laboratory practice). We are FDA 21 CFR Part 11 compliant and meet US and EU applicable regulatory guideline requirements.
Range of Laboratory Services
- Expert Bioanalytical Laboratory Services
- Full service support for clinical trials globally with project management, data management, sample management, logistics. We have experience working with central labs or directly with field sites
- Virological and immunological focused analysis using cell-based, molecular and immunology platforms
- Analysis of biomarkers from a broad spectrum of sample matrices (e.g. serum, plasma, peripheral blood mononuclear cell(PBMC), nasal swabs, nasal washes, etc)
- Novel products and services including: Viral sample stabilisation solutions and field trial collection kits, novel biomarkers and assays focused on Flu, RSV and HRV viruses
- Extensive experience in drug development, biomarker analysis and diagnostics
- Comprehensive range of respiratory disease areas including influenza, respiratory syncytial virus, and human rhinovirus
- Drug compound experience; small molecules, biologics, vaccines, anti-virals, immune modulators and others
- Extensive menu of assays to meet your specialty biomarker needs. Please contact us for a current list
Specialty Services we can offer
- High throughput sample analysis
- Matrix optimisation and validation
- Bespoke assay development and validation
- Flexible validation options from fit for purpose through fully validated assays (LLOD, LLOQ, Linearity, Precision, Reproducibility, Range) to FDA and MHRA guidelines
To find out more about our lab services and/or to discuss bespoke analysis needs, please Contact Us.