For clinical-stage medtech, diagnostics & medical devices
Spain will want its own evidence. Start building it before you need it.
A Spanish purchasing committee discounts foreign data. By the time you are ready to sell here, the evidence you need takes a year you have not budgeted. Beginning it during your clinical phase removes that year — and gives your next funding round something concrete to point at.
What you get
An implementation-ready package. Not a report.
I bring the Spanish stakeholders your investigation needs into one room — professional medical and nursing societies, university and hospital investigators, and where relevant a CRO — and coordinate them until there is something that can actually be run.
- A protocol ready to implement
- Written with the investigators who would actually run it, not handed to them afterwards.
- Defined roles across all parties
- Who does what, on your side, the sites, the societies and — where you need one — the CRO.
- A project plan with real clocks
- Ethics review, centre conformity and contracting on the timelines Spain actually runs, not the published minimums.
- A costed budget
- What it takes to run, per site and in total, in a form your board or your investors can read.
Where I stop
I do not run studies. My output is your input.
Everything downstream of the package — monitoring, source data verification, safety and vigilance reporting, data management, statistics, holding the trial master file, submitting as the sponsor's agent — needs a quality management system, controlled procedures and records an inspector can audit. That is a CRO's job and it should stay a CRO's job. You run the study with them, with the university, or with the society network. I can broker that hand-over; I do not staff it.
Why this is not something a CRO does for you
A CRO buys site access transactionally, one study at a time. What decides whether a Spanish investigation recruits is whether the clinical community owns the question — and in primary care, whether the nurses who would use the device are behind it. That is built over years, not procured.
It is also why this work belongs before you appoint a CRO, not after. What you leave with is the brief they will bid on.
How this is structured, and why it matters
You pay me for advice, under a consultancy agreement. Any funding for a society, a hospital or an investigator goes to that organisation directly, under its own agreement — never through me, and never bundled into my fee. Sites and investigators are selected against scientific criteria written down before any name is proposed. My fee does not change with what the study finds, or with whether it goes ahead at all.
None of that is boilerplate. Research that looks like it was bought is worth less than no research, and a Spanish ethics committee is very good at telling the difference.
Start with a first meeting.
An hour, free, confidential — NDA on request. We work out what your product would need to be investigated here, who would have to be in the room, and roughly what that costs. If it fits, you get a written offer with deliverables, milestones and named people on both sides.