The CRF supports early-phase device and diagnostic studies with the unglamorous infrastructure — pharmacy, sample handling, overnight cover — that startups discover late.
Approach with a protocol outline and a work package, not a hope.
The infrastructure is the point. Research nursing, pharmacy support, sample processing, monitored beds and the governance machinery for a sponsored study are individually unremarkable and collectively impossible to assemble at short notice. A device company attempting a first study without them typically discovers this in month four.
Governance timelines are the other thing to plan around. Ethics approval, health research authority approval and local capacity assessment are neither optional nor fast, and the facility's staff are experienced at telling sponsors realistically how long their particular study will take to start. Believing them is advisable.
Specification
- Early-phase clinical space
- Sample handling and pharmacy
- Governance support for sponsored studies
- Monitored beds with overnight capability
- Research nursing and clinical trials pharmacy
- Sample processing and short-term storage on site
What it is the right answer to
Jobs this facility genuinely suits.
- Formative and summative usability studies with clinical users
- Early feasibility studies for devices and diagnostics
- Comparative measurement studies against an established clinical method
- Sample collection for assay development under an approved protocol
- First-in-human studies where the risk profile has been properly assessed
What to bring
Turning up without these costs facility hours rather than bench hours.
- A protocol outline, even a rough one, rather than an intention
- A clear statement of the device's intended use and risk classification
- Evidence of bench validation completed before any patient is involved
- A sponsor arrangement, and clarity about who is taking sponsor responsibility
What you leave with
- Study data collected under an approved protocol with full documentation
- Consented session recordings where usability work forms part of the study
- A dataset and report suitable for a regulatory submission
- Clinical observations on workflow that no bench test would have produced
Limitations
Worth knowing before you write the proposal.
- No study begins without approvals, whatever the commercial urgency
- Bench validation must be complete first; the facility will not substitute for it
- Recruitment rates are frequently slower than sponsors project