Evidence strategy & study design.
Before the first participant, we map the full evidence path, what needs proving, to which authority, on what timeline, and design protocols and endpoints that make the answer defensible.
The work, made concrete.
Not a service brochure, the actual scope, the actual deliverables, and how it plugs into ECS®.
- Evidence gap analysisWhat's already known, what's contested, what needs new data, mapped against your product's stage and claim ambition.
- Target evidence profileThe endpoints, comparators, populations and settings that regulators, payers and prescribers will accept.
- Study design & endpointsInterventional, hybrid or real-world designs sized to the decision they need to support.
- Programme-level roadmapOne study rarely tells the whole story, we plan the sequence and share the same data model across it.
Every deliverable has a name on it.
What you receive.
Every engagement lands with named artefacts you can use.
- Evidence strategy document (regulator- and payer-facing)
- Target evidence profile & endpoint rationale
- Recommended study designs with feasibility notes
- Multi-study programme roadmap where relevant
The strategy is authored on ECS® from day one, so protocol, eSource forms, monitoring plan and analysis set inherit the same evidence model, no translation loss.
Three moments this service earns its place.
If any of these describe where you are, this is the right entry point.
- Moment 01
You have a new product / claim and no fixed evidence plan yet.
- Moment 02
A prior programme didn't clear regulatory / payer review.
- Moment 03
You're moving from a single study into a full evidence programme.
Often engaged together.
Protocol development & scientific writing
Turn your idea into a regulator-ready protocol, rigorous, defensible, submission-grade.
Learn moreRegulatory strategy, submission and market access
Route to approval and route to reimbursement: feasibility, EMA/FDA and MDR/IVDR pathways, submissions, HEOR and payer dossiers.
Learn moreClaim strategy & substantiation
Defensible claims and the evidence they require, aligned to EFSA/FDA and consumer-health frameworks.
Learn moreTalk to the team about this service.
Tell us the study or the question, we'll come back with a scoped answer.