Solutions
Clinical studies and research, on production-grade infrastructure
Collect your first data in weeks, run clinical investigations with real patient data, and move to market without rebuilding. Extra Horizon's Research and Pre-Market licences put your study on the same certified platform your product will launch on.
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Before the market
A study is a product launch in miniature
Pilot studies, clinical investigations and IVDR performance evaluations all need real patient data handled properly — long before there is revenue to fund a backend team.
Infrastructure built to be thrown away
Prototypes built by a PhD student, a university partner or an agency collect the first data — and then have to be rebuilt, just as the study that needs them is about to start.
Real patient data, real obligations
The first enrolled patient brings DPAs, DPIAs, access control and audit trails with them. Ethics committees and study sites will ask to see all of it.
Evidence that has to hold up later
If your study data will support a regulatory claim, the platform it ran on has to withstand scrutiny long after the study ends — not just work today.
One platform, every phase
Start small, grow without re-platforming
Licensing follows your product through its lifecycle. The data model, access rules and automation you build for your first study carry forward unchanged — moving to the next phase is a licence change, not a migration.
Research licence
Collect first data and stand up a working prototype in weeks, on infrastructure you won't have to throw away.
- Compliant data collection from day one
- Configuration as code from the first commit
- Documentation for ethics and funder submissions
Pre-Market licence
Run clinical investigations, IVDR performance evaluations and usability studies with real patient data on pre-certified infrastructure.
- DPA and DPIA support
- Role-based access and audit trails
- Separate development, test and production
Commercial licence
Carry the validated configuration into certification, launch and new markets — promoted, not rebuilt.
- Data residency per market
- Continuous compliance as a service
- Scales with patient volume
Built on the Extra Horizon platform
Everything a study needs, from the first participant
Identity & access management
Model each study site as a group and give investigators, site staff, monitors and participants exactly the access their role allows.
Learn more →Medical backend-as-a-service
Define your study data as schemas that validate at the API, with workflows for enrolment, visits and follow-up.
Learn more →Device fleet management
Track which study device went to which site and participant, and which firmware it ran for the duration of the study.
Learn more →Diagnostics in the cloud
Run your algorithm on study data as it arrives, and keep every result and review for your performance evaluation.
Learn more →Regulations & certifications
Answer ethics committee and site data-security questions from an existing evidence pack, backed by ISO 13485, ISO 27001 and IEC 62304 certification.
Learn more →Free sandbox
Try the platform with a fully deployed test environment before your study starts — no commercial commitment needed.
Learn more →From trial to market
One backend, from the first trial site to launch
ABCDx is taking LVOCheck — a stroke test performed in the ambulance — through clinical validation. Extra Horizon supports its rollout across emergency medical services and clinical trial sites without bespoke infrastructure per location, and carries it from clinical trials to commercial deployment without rebuilding the backend for each new phase.
Read the ABCDx case →Built for regulated studies
Study data that stands up to scrutiny
The data you collect today may end up in a submission. It should run on infrastructure that will still stand up to a notified body when it does.
Traceable study data
Clinical investigations and performance studies expect controlled, traceable data handling. Versioned configuration and audit trails give you that record from the first participant.
GDPR for study data
Special-category health data needs a DPA, a DPIA and a clear record of processing. The platform arrives with the documentation to support them.
A qualified supplier
The platform underneath is ISO 13485, ISO 27001 and IEC 62304 certified and slots into your supplier controls — evidence you inherit, not produce.
Let's talk about your study!
Get in touch, explain what you want to build, or have us help you build, and we'll get back to you ASAP! →