Patient experience data that makes clinical evidence submission-ready.
Unwritten Health helps pharma medical-affairs, market-access and regulatory teams, medical-device and SaMD manufacturers, digital-health developers, and NIHR-funded academic teams put patient experience data, the lived reality of people who use their treatments, into the submissions regulators, HTA bodies and payers now demand.
recruited through community partners
profiled on every participant at sign-up
outputs pre-formatted for each
Patient experience data is not the same as clinical trial data.
Clinical trial data
Tells regulators whether a treatment works, on average, in a selected population.
Patient experience data
Tells them who was left out, how the treatment actually fits into the person's life, and where the evidence file is silent.
That is what the EU Joint Clinical Assessment, the MHRA Inclusion and Diversity Plan, and NICE's inequality guidance now require. It is also what your PMCF, ESF and DTAC files are graded on.
Unwritten Health captures this data through longitudinal surveys, moderated focus groups, patient councils and lived-experience narratives, from a 6,000-strong UK panel where every participant is profiled at sign-up on the eight social factors that shape health outcomes: age, ethnicity, first language, income, geography, disability, caring responsibilities and health literacy.
Which of these four are you?
Pharma & biotech
You are running a JCA or NICE submission, planning a PMCF, or standing up a patient council.
The JCA-Ready Evidence Package delivers the subgroup and PICO patient-input file the EUnetHTA 21 framework asks for, in the 100-day JCA window. The Patient Council as a Service gives your medical-affairs team a standing, auditable evidence-generation function.
Explore pharma solutions →Medtech & digital health
You are preparing a SaMD, digital-health or medical-device product for NHS procurement, NICE ESF or NHS DTAC review.
The SaMD Red-Team stress-tests your algorithm against the populations your training data under-represents. The ESF/DTAC Evidence Pack and the PMCF Equity Gap Assessment close the two gaps NHS and MHRA reviewers ask about first.
Explore medtech solutions →NIHR-funded studies
You are writing an NIHR grant or running an NIHR-funded study that must satisfy INCLUDE.
The NIHR PPI Package delivers a fully-costed patient-and-public-involvement partnership with community organisations already inside the panel. Signed MOUs before your grant submission, meeting facilitation across the grant lifecycle, end-of-grant PPI report.
Explore NIHR solutions →Academic & non-profit research
You are running secondary analysis, a community-partnered study, or a public-good project.
Academic access to the Equity Engine dataset is available at cost, subject to Trust & Ethics Board review. Non-profit access is free by application. Community partners retain veto over outputs that identify their community.
Explore access options →We work through UK community organisations, patient advocacy groups, and Contract Research Organisations to reach the populations sponsors need to hear from. These are the sampling frame and delivery network behind the Equity Engine, not the audiences we sell to.
The cost of not doing this is now measured. Not theoretical.
in unrealised prescription-drug sales for every day of HTA delay after regulatory approval. That is $24 million a month, $144 million on a six-month slip.
the average cost of a single major protocol amendment, the fix an inclusion gap forces if it is caught late. Delays of 3 to 6 months follow.
the annual cost to the NHS: £4.8bn in avoidable treatment and £31bn in lost productivity, from health inequality in England every year.
Designing clinical development without lived-experience input creates a liability we call inclusion debt. Amendments, screen-fails, HTA queries, label limitations, DTAC deferrals, and post-market failures are all repayments of it. We help you pay it down at the cheapest point, before submission, not after.
Where does your evidence file sit against these numbers?
Twenty questions. Six domains. A plain-English diagnosis of the regulatory clauses you are exposed under.
Take the Regulatory Readiness Scorecard →560 participants of African descent in 12 weeks.
A Phase II biotech engaged the Equity Engine before protocol lock, and hit 112% of a recruitment target their prior CRO said would take a year.
Six-month start-up on a 9-to-12-month industry clock. $2.4M to $4.8M in captured value from earlier market entry. FDA Diversity Action Plan file ready at submission, not after.
Why it worked
- Engaged before protocol lock, not after screen-fail
- Community-partner sampling, not paid ads
- SDoH-tagged panel, subgroup evidence produced by default
- FDA DAP file assembled at submission, not after
Where are you on the regulatory clock?
The Regulatory Readiness Scorecard is a free, 15-minute self-assessment. Twenty questions across six domains:
Trust is not optional in a data business. It belongs on the homepage.
Consented at every stage
Every participant re-consents on a use-case-specific schema, at NIHR guide rates.
Community-partnered
Every participant recruited through a named community organisation under signed memorandum of understanding, not through a digital panel aggregator.
Independently governed
Our Trust & Ethics Board includes a lay chair, a clinical ethicist, a data-protection officer, and two community-partner representatives with veto power over the release of any output that identifies their community.
UK-anchored
Data stays in UK jurisdiction. Every output is auditable to raw response level.