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.
Find out more about Lab services below or contact us.
What’s new in Lab Services
During hVIVO’s attendance at ‘Molecular Med Tri-Con’ in San Francisco (March 2016), we presented two scientific posters.
“Measurement of intracellular replicative strand in Respiratory Syncytial Virus (RSV) infected human volunteers” and “Use of allele specific RT-qPCR to measure the differential infectivity of HA variants in human infection models using A/Wisconsin/67/2005.”
To view both of these hVIVO posters click here.
Range of Laboratory Services
- Virological and immunological focused analysis using cell-based, molecular and immunology platforms
- Extensive experience in drug development, biomarker analysis and diagnostics
- Drug compound experience; small molecules, biologics, vaccines, anti-virals, immune modulators and others
- Analysis of biomarkers from a broad spectrum of sample matrices (eg; 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
- Comprehensive range of respiratory disease areas including influenza, respiratory syncytial virus, and human rhinovirus
- We offer 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
- 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
- We have an extensive menu of assays to meet your specialty biomarker needs. Please contact us for a current list
- Expert Bioanalytical Laboratory Services
Specialty Services we can offer
- Bespoke assay development and validation
- Matrix optimisation and validation
- High throughput sample analysis
- Flexible validation options from fit for purpose through fully validated assays (LLOD, LLOQ, Linearity, Precision, Reproducibility, Range) to FDA and MHRA guidelinesBespoke assay development and validation
hVIVO Laboratory Support Services
hVIVO can offer a range of laboratory support services which are summarised here, but please contact us if you would like to discuss a specific stand-alone laboratory analysis need or something more comprehensive in scope.
To find out more about our lab services please contact us using the form here.