Clinical validation support.
Support for organisations preparing or executing clinical validation studies for in-vitro diagnostic assays — from study design through to documentation.
What we mean by clinical validation support.
Clinical validation is the scientific and methodological work that turns an analytical result into clinical evidence: protocol design, statistical planning, comparator selection, site coordination, and the documentation regulators expect. Get any one of those wrong early and the whole study can fail to support the claim it was intended to support.
We work as support — alongside the sponsor’s clinical and regulatory teams, not in place of them. The deliverable is a study that holds up under review, not a service-provider relationship that runs the study for you.
Most of the value in this work shows up at the front end. A protocol that fails to anticipate a particular bias, a statistical plan that under-powers the primary endpoint, a comparator that turns out to be a moving target — these are cheap to fix in a draft and expensive to fix mid-enrolment.
Who benefits from validation support.
IVD developers
Manufacturers preparing performance studies for IVDR submissions and looking for a methodological second pair of eyes.
Clinical research organisations
CROs coordinating IVD studies who want statistical and protocol review independent of the sponsor.
Hospitals and reference labs
Clinical sites evaluating new diagnostics in a controlled setting and wanting study design help before enrolment opens.
How a validation engagement runs.
Most validation engagements begin with a protocol review or a gap analysis. From there, work runs in defined phases against a study plan; outputs are written artifacts — protocols, statistical analysis plans, study reports — that fit into the sponsor’s regulatory file. We don’t recommend changes verbally; if a change is worth making, it goes into the document trail.
Other ways we partner.
CRISPR assay development
Design and optimisation of Cas-based detection assays for nucleic-acid targets in clinical and research settings.
Molecular diagnostics consulting
Strategic guidance on assay architecture, sample workflows, and translation from concept to clinical use.
Regulatory strategy
IVDR-aligned planning for CE marking pathways, technical-file structuring, and post-market surveillance.
Contract research
Targeted laboratory work for biotech and pharmaceutical partners — flexible scope, rigorous documentation.
Global procurement services
Sourcing of medical devices, IVDs, and pharmaceuticals from European supply chains for international partners, with full audit and compliance documentation.
Sharpen your study before you start it.
If you’re early enough in study planning that protocol changes are still cheap, that’s the moment we add the most value.