Pricing

RWE for regulatory submissions

Turn real world data into evidence regulators accept

Most RWE fails at the agency not because the data was wrong, but because the design, provenance and framing were decided too late. This hub helps RWE and regulatory teams build submissions on evidence that survives scrutiny, from vetting the dataset to writing the briefing document.

Get the briefing document template

Start here: the RWE Briefing Document Template

The exact structure we use to put real world evidence in front of FDA and EMA, section by section, with guidance notes on the part that decides the outcome: how you frame the question. Free, and yours to keep.

Download the template

The FDA & EMA Interaction Playbook

Which meeting to request, when, and briefing books that get straight answers.

Get the playbook

State of Evidence Generation 2026

The annual report on how evidence gets planned, funded and used across drug development.

Get the report

Brief: What your data source cannot see

Completeness, not size, decides whether a real-world data source can support your comparison. Four pages, free.

Get the brief

More free briefs on this topic: RWE in 13 of 706 FDA approvals  ·  Read the statistical review

Watch: the video series

Latest from this hub

You've conducted a Single-Arm Trial and now regulators are asking questions

You've conducted a Single-Arm Trial and now regulators are asking questions

What to do when regulators come back with questions about your single-arm trial, and how real-world evidence can answer them.

Read the article
FDA Guidance on External Control Arms: A Checklist For Drug Developers

FDA Guidance on External Control Arms: A Checklist For Drug Developers

A practical checklist for building an external control arm that meets FDA expectations.

Read the article
Target trial emulation for non-statisticians

Target trial emulation for non-statisticians

A plain-English guide to target trial emulation and how it makes real-world evidence stand up like a randomized trial.

Read the article
When clinical development goes wrong, RWE provides solutions

When clinical development goes wrong, RWE provides solutions

How real-world evidence can rescue a development programme when the clinical path hits trouble.

Read the article
How to use RWE to support regulatory strategy

How to use RWE to support regulatory strategy

How to position real-world evidence so it strengthens your regulatory strategy.

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The principles that don't move: future-proofing your RWE against evolving FDA and EMA guidance

The principles that don't move: future-proofing your RWE against evolving FDA and EMA guidance

The design principles that keep your RWE robust as FDA and EMA guidance evolves.

Read the article

Planning a submission with RWE in it?

The cheapest time to fix an evidence problem is before the design is locked. If you are weighing a data source, a comparator or a methods question, get in touch. A brief call is usually enough to tell whether your evidence will hold.

Talk to the team
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