# Clinical & access evidence strategy
> One evidence plan that serves the clinical programme and the access case.
Source: https://www.visfo.health/projects/clinical-access-evidence-strategy
Tags: Sprint

_One evidence plan that serves the clinical programme and the access case._

We connect the clinical development plan to what payers and HTA agencies are likely to ask, so the evidence generated for regulators also supports the value case. Delivered as an evidence strategy with the gaps, the trade-offs and the sequencing made explicit.

## What it is

A single evidence strategy that holds the clinical programme and the access case together, rather than two plans that only meet at submission. We map what the clinical programme will produce against what payers, HTA agencies and clinicians are likely to ask, and show where those diverge.

Built for teams where development decisions are still open enough to shape the access case, and for teams that have inherited a programme and need to know what the evidence will and will not support.

## How we run it

1. **Frame** — Agree the decisions in play, the markets that matter, the audiences the evidence has to satisfy and the constraints the development plan is already under.

2. **Ingest** — Pull the development plan, the existing evidence base, comparator and precedent evidence, and the relevant HTA and payer expectations into one view.

3. **Synthesise** — Map evidence against expectation, surface the divergences between regulatory and access needs, and set out the options with their trade-offs and feasibility.

4. **Deliver** — Ship the evidence strategy, the gap view and a working session with clinical, medical, HEOR and access together.

## What you get

- Evidence strategy spanning clinical and access requirements

- Map of evidence against likely payer, HTA and clinical questions

- Divergences between regulatory and access needs made explicit

- Options and trade-offs with feasibility and sequencing

- Cross-functional working session and agreed next steps