Pre-specification is what makes it credible
An analysis plan written after the data has been seen is not evidence, it is a story. Pre-specifying the plan, and saying so, is the single largest determinant of whether a reviewer accepts the result.
Offering 4 of 5
Evidence built to be defended by somebody other than you.
A protocol-driven study with a pre-specified analysis plan, sensitivity analyses, negative controls where appropriate, and a written position on limitations. Designed to hold up in front of a regulator, a health technology assessment body, a payer or a journal.
Real-World Evidence Study
Why the protocol discipline matters
Reviewers attack the method, not the finding
A study is challenged on cohort definition, confounding, missing data and sensitivity. Each of those is addressed by design here rather than defended after the fact.
It survives a change of audience
Evidence built for a payer often ends up in front of a regulator, or in a manuscript. Building to the highest standard in the room means it travels.
Negative results are still results
Because the plan was fixed in advance, a null finding is publishable and defensible rather than an embarrassment to be buried.
4
Real-World Evidence Study
A protocol-driven study with a pre-specified analysis plan, sensitivity analyses, negative controls where appropriate, and a written position on limitations.
- Timeline
- Four to twelve months. Approval timelines, not analysis, drive the range.
- Buy it when
- The output will be seen by a regulator, an HTA body, a payer or a journal, or it will be used to support a reimbursement or label position.
- Do not buy it when
- You need a decision input in six weeks. The protocol and approval discipline that makes this defensible is also what makes it slower. Offering three is the right instrument for speed.
Deliverables
What you actually receive.
Named, dated and agreed at scoping. Every one of these is a thing you can hold, circulate internally and be held to, not a description of an activity.
A study protocol
Objectives, design, population, exposure and outcome definitions, and the analysis plan, pre-specified and dated before execution.
A statistical analysis plan
Primary and secondary analyses, handling of confounding and missing data, sensitivity analyses, and where relevant negative controls with multiplicity control.
A study report
The full report in the structure your audience expects, whether that is a regulatory-style report, an HTA submission section or a manuscript draft.
Result tables and figures
Publication-grade, with the underlying tabulations supplied alongside.
A manuscript or dossier section
Drafted to fit the specific submission or journal, rather than handed over as raw output for your team to reshape.
A limitations and generalisability statement
Explicit, written at protocol stage, and carried through to the report unchanged.
How it runs
Four steps, and you see the direction before you see the deck.
Protocol
Objectives, design and definitions agreed and dated. Registered where the target audience expects registration.
Governance and approvals
Ethics and data governance submissions, run in parallel with analysis design wherever the market permits.
Execution
Analysis performed in-market inside the controlled-access environment, following the pre-specified plan.
Report and review
Full study report, sensitivity analyses, and the submission or manuscript section it feeds.
Alongside every engagement: weekly updates, methodology agreed before work starts, quality control at every phase, interim reporting rather than a single reveal, and milestones you accept rather than discover.
What it feeds into
Programme Partnership
A study that worked becomes a repeatable capability across a portfolio, on a cadence you set.
Is this the one you need?
Describe the decision you are trying to make. If a cheaper offering answers it, we will tell you that instead.