Three evidence-based resources for capturing patient experience data, mapping it to evidence standards across markets, and designing trials that actually include the patients the data is about. Co-created with patients, payers and HCPs by a founder who has spent a decade doing this work inside NHS and pharma.
Decisions made about patients without their voice in the data quietly cost more than the cost of capturing it well. Three reasons it has moved from nice-to-have to load-bearing.
Pharma programmes that miss the patient experience layer face higher trial dropout, weaker label negotiations, and avoidable NICE and EMA rejections. Decisions made about patients without their voice in the data carry real cost.
AMNOG JCA, LFSS Article 65, AIFA reform. Patient experience evidence has moved from a nice-to-have to required at submission across multiple markets, with more changes coming.
Most pharma teams commission patient research without a structured brief or a clear evidence target. The result is inconsistent outputs, wasted budget, and evidence that does not hold up at HTA submission or in front of patients themselves.
Each resource is a working document, not a slide deck. Built from real briefs and real EU submissions. Practitioner knowledge at an accessible price.
A structured briefing framework pharma and healthtech teams can use to commission patient insight research. Covers strategic context, objectives, target populations, and methodology preferences.
Country by country patient evidence standards for Germany, France, Italy, Spain, the Netherlands, and Belgium. Covers 2025 to 2026 regulatory updates, HTA requirements, and real-world evidence expectations.
A structured six-part checklist for assessing whether a clinical trial programme is genuinely ready to recruit and retain diverse, representative patient populations. Covers regulatory compliance, protocol design, site readiness, and health equity.
All prices in GBP. VAT may apply depending on your location. One-time purchase, no subscription.
The structured briefing framework for commissioning patient insight research. Covers the full brief lifecycle from strategic context to agency response guidance.
A six-part structured checklist for assessing clinical trial inclusion readiness, from regulatory compliance and protocol design to site readiness and health equity.
Country by country patient evidence standards for 6 EU markets, updated for 2025 to 2026 regulatory changes including AMNOG JCA, LFSS Article 65, and AIFA reform.
All three resources together. The complete toolkit for pharma and healthtech teams operating across patient intelligence, market access, and clinical trial inclusion.
Medical affairs, market access, and healthtech teams can access team pricing. Contact us to discuss a custom licence covering unlimited internal use.
EU-level JCA now mandatory for new oncology and ATMPs, changing what patient evidence is required at submission and how benefit assessment is conducted across member states.
France's Social Security Financing Act now requires strengthened real-world evidence commitments at time of HAS submission, with patient-reported outcomes explicitly included in assessment criteria.
Italy's Medicines Agency has revised its managed entry agreement framework, increasing the weight given to patient experience data in conditional reimbursement negotiations.
These resources are not for generalists. They are written for practitioners who know enough to know what's missing.
The Patient Intelligence Brief and Inclusion Checklist work across geographies. The European Navigator adds the 6-market EU layer when you need it.
The Patient Intelligence Brief gives you the framework to brief agencies and internal teams consistently.
The bundle gives you all three resources to use across client engagements.
The Inclusion Readiness Checklist gives you a structured six-part RAG assessment to run before recruitment opens.
Ashish Rishi, Founder and CEO, Unwritten Health. Member of the Scientific Advisory Board for IHI READI, the Horizon Europe initiative on health equity and research infrastructure. Based in London, working with healthcare and life sciences organisations across the UK and EU.
His career has been dedicated to making healthcare more inclusive, not as a moral cause, but as a practical necessity. Systems that exclude people from their data do not just fail those people. They fail everyone who relies on the decisions that data shapes. His work starts with a question most systems never ask: who is not in the data?
At Unwritten Health he is building something to change that. Turning diverse lived experience into decision-ready data that helps life sciences see not just what happened, but where understanding eroded and trust was lost long before outcomes told the story. He frames this as an evidence problem and a design problem, with real consequences for research, innovation, policy and care delivery.
Three resources, one bundle. No subscription, no upsell calls.