Tell us about your endpoint
Tell us the endpoint, the phase, the number of sites and timepoints, and the regulatory framework the programme reports to. We will tell you which assay format fits, what validation level is appropriate, and what the study will take.
That reply comes within one working day.
WHY IT MATTERS
Clinical data has to hold up – across every assay, site and timepoint
Analytical performance
Validated assays need documented sensitivity, precision, accuracy and reproducibility at the level sponsors and regulators expect. Not “the platform is validated”, but this assay, in this matrix, to this standard.
Consistency over time
Clinical samples arrive across sites, cohorts and timepoints rather than in one controlled batch. Analytical consistency has to hold across all of it, which depends on bridging samples, plate layout and a control strategy agreed before the first sample runs. Retrofitting that is not possible.
Quality from sample to report
The quality framework cannot begin at the instrument. It runs from sample receipt and chain of custody through analysis, data integrity and final reporting.
Clinical evidence is only as strong as the workflow behind it.
WHat we measure
Match the assay to the clinical decision
Validated neurological endpoints
Validated immune and serology endpoints
Broad longitudinal profiling
Ultra-sensitive focused measurement
Trial-specific endpoints
Applications
Built for the standards clinical work demands
Clinical biomarker work has to withstand sponsor audits, QA review and regulatory inspection. That means the quality framework, the platform validation and the scientific oversight all have to hold at once.
Quality framework
HTA licence 12818, the UK framework governing the storage and use of human tissue. GCP-compliant workflows. Quality processes aligned to relevant ISO 15189 principles, the international standard for medical laboratories, with accreditation in progress. Documented SOPs, sample chain of custody, data-integrity controls and audit-ready quality systems on every project.
We are not GLP-certified and do not take GLP-regulated bioanalysis. Where your programme needs it, we will say so up front.
Validation scaled to context of use
From fit-for-purpose research workflows through to regulatory-facing clinical trial bioanalysis. We apply the validation the study needs, and we tell you why at scoping.
Senior scientific oversight
A named senior scientist from study design through final reporting. The same team can stay involved from preclinical biomarker development into clinical execution, preserving analytical and biological context at the point where a supplier change is most expensive.
The practical detail
Turnaround
Two weeks from sample receipt, confirmed in writing at quote
Quote
Multi-site delivery
Longitudinal studies
Cohort size
Data output
Validation reporting
Quality framework
Why you can trust this now
The research journey
From animal model to first-in-human, without switching laboratories.
02
Preclinical Development
Target engagement, pharmacodynamic biomarkers, toxicology endpoints, and translational bridging from animal models to first-in-human.
Explore
03
Translational & Clinical Research
Current stage
Validated biomarker workflows for clinical trial endpoints, regulatory-grade bioanalysis, patient stratification, and longitudinal monitoring.