Ledidi + Patient Watch: Closing the gap between the patient and the post-market file
Patient Watch is a patient-reported outcomes platform built alongside working clinicians. It started in 2021 as a digital version of the paper symptom diaries founder Guy Solan watched his surgeon father work through, and has grown through NHS quality-improvement projects, private orthopaedic and sports-medicine clinics, and multi-centre real-world evidence and post-market surveillance programmes for manufacturers across the UK, Germany and Denmark. A patient is enrolled in clinic by QR code in under thirty seconds; reminders, validated questionnaires and follow-up windows run automatically; and Patient Watch reports engagement rates around 85% on its programmes.
Ledidi sits on the other side of the study. Our platform is where the clinical, device and safety data lives: a validated, no-code EDC for trials and PMCF investigations, alongside registries and real-world data collection for longer-term follow-up. Sponsors design their own studies, see their own data in real time, and keep it when the study ends.
Our no-code platform is validated for GCP and FDA 21 CFR Part 11 compliance, with an independent GxP audit completed in January 2026 with no deviations, and ISO 27001 and SOC 2 Type II certification.
Together, the partnership is a simple division of labour. Patient Watch handles the patient: enrolment in clinic, engagement, reminders and the PROMs themselves. Ledidi handles the evidence: clinician-entered data, device and safety data, monitoring, audit trail, analysis and the exports that go into the technical file. Patient-reported data collected in Patient Watch can be brought into the same Ledidi study or registry as the clinical record, linked at patient level, so a sponsor ends up with one dataset rather than two.
Why Ledidi and Patient Watch have joined forces
Ask a medtech company how they collect patient-reported outcomes for a PMCF study and the honest answer is often an emailed survey link, a spreadsheet and a lot of chasing. Response rates hover around 15%, the clinician who saw the patient never sees the data, and when the Notified Body asks where the numbers came from, the trail runs through someone’s inbox. Patient Watch was built to fix the front end of that problem; Ledidi was built to fix the back end. Working together means a manufacturer can run a PMCF programme where the surgeon enrols the patient in clinic, the patient reports from home and the regulatory team works from a single validated record, without asking any of them to do more admin than they do today. The referral runs both ways: if a company needs a clinician-enrolled PROMs programme, Patient Watch is the right answer; if it needs a validated EDC or a registry, Patient Watch will point them to us.
Who this is for
If you are a device or diagnostics manufacturer with PMCF, PMS or real-world evidence obligations and you are currently meeting them with survey tools and email, this is the partnership we built for you. PMS isn’t just a compliance tick box: it’s a route to real-world evidence, and most teams don’t realise the value they are missing. We help companies realise that potential.
If you are a CRO or regulatory consultancy designing post-market programmes for clients, it gives you a stack you can recommend without having to build or own it: a validated EDC for the clinical and safety data, and a PROMs layer that patients actually complete. Neither Ledidi nor Patient Watch replaces the CRO; both are built to work alongside one, and several of our partners already do.
It is also relevant to clinicians and clinical teams who want their patients’ outcomes to count towards evidence rather than sit in a filing cabinet.
You can find Patient Watch at patient.watch. To talk to us about a joint study, get in touch or book a demo.
