Budget
£25–40k
Duration
14 weeks
Closes
17 Oct 2026
Background
We have an assay platform that performs well in our own hands, which is the least persuasive possible evidence. Before we approach a clinical partner we need bench validation conducted by an accredited laboratory against a recognised comparator method, documented to a standard that will support a regulatory submission.
This includes the parts that are tedious and non-negotiable: precision and repeatability across operators and days, linearity across the measuring range, interference and cross-reactivity, and stability under the storage conditions our product will actually experience rather than the ones it would prefer.
Our quality system is operating and the study will be conducted under it. We need a laboratory that is comfortable working within a sponsor's quality framework and generating records that will withstand an audit.
Scope
- Agree a validation plan covering precision, linearity, interference and stability.
- Conduct the study against a named recognised comparator method.
- Assess repeatability across operators, days and reagent lots.
- Characterise interference and cross-reactivity against an agreed panel.
- Assess stability under the storage and transport conditions we specify.
Constraints
The awkward facts, stated now rather than in week six.
- The study must be conducted under our quality management system
- Reagent lots are limited; the plan must fit the available quantity
- The comparator method is specified and not open to substitution
- Documentation must be audit-ready, which adds effort and is not optional
Deliverables
- Agreed validation plan with acceptance criteria set in advance
- Raw data with full traceability to operator, day and lot
- Statistical analysis against the pre-set acceptance criteria
- Interference and cross-reactivity report
- A validation report formatted for inclusion in a technical file
Milestones
- Week 2Validation plan and acceptance criteria agreed and signed
- Week 5Precision and linearity work complete, raw data delivered
- Week 10Interference, cross-reactivity and stability work complete
- Week 14Final validation report delivered in technical file format
Who should apply
- Accredited clinical or diagnostic laboratory
- Experience generating data for device technical files
- Ability to work under a sponsor's quality management system
- A named study director with comparable prior studies
How applications will be judged
In roughly this order.
- Accreditation scope covering the proposed work
- Prior validation studies that formed part of a successful submission
- Quality of the proposed validation plan and pre-set acceptance criteria
- Comfort with audit-ready documentation, evidenced rather than asserted
Terms
- All data and reports belong to us and will form part of a regulatory submission
- The laboratory retains its own records as required by its accreditation
- Assay composition is disclosed under confidentiality and may not be published
- Acceptance criteria are fixed before the study begins and will not be revised afterwards
Apply
Tell the publisher who you are and what you would do. We pass it on. The rest is between grown-ups.
We will share the assay details and the comparator specification under a confidentiality agreement before you price the work.