Real-world evidence, joined to your clinical data.
Retrospective, prospective and ambispective studies, non-interventional studies (NIS), patient registries, EHR-based research and patient support programmes, captured in the same ecosystem as your clinical trials, so the evidence speaks one language.
Real-world data is only as good as the system that captures it.
RWE too often lives in tools disconnected from clinical data, creating reconciliation work, gaps and questionable robustness, slow and fragile exactly when sponsors need evidence across many settings.
One ecosystem, one source of truth.
- Registries & observationalDesigned and run on ECS®, with structured capture and audit trails from day one.
- Patient support programmesPSPs that double as real-world evidence engines, with consent built in.
- RWD ingestionEDC-EHR ingestion powered by Deep Dialogue, study-specific NLP turns records into eCRF fields, audit-trailed on ECS®.
- Human data scienceValidated outcomes characterised rigorously.
One ecosystem makes evidence portable.
- Clinical and real-world data in one system means a single source of truth across a product's life.
- ICH E6(R3) and current guidance explicitly validate RWD and integrated evidence systems.
- Qualitative depth where metrics are still emerging, so the language stays credible and the numbers hold.
- Multi-country reach through Evidilya's communities and recruitment engine.
Extend and strengthen your RWD.
AI can extend historical series, build synthetic cohorts and support causal inference, turning real-world data into stronger, more comparable evidence, in line with emerging regulatory precedent.
Retrospective, prospective, ambispective, one ecosystem.
The evidence question decides the design. ECS® carries all three, so the data speaks one language across the product's life.
- RetrospectiveLook back with rigour.
Chart review, EHR-based and database studies. The hypothesis is set, the data already exists, we structure, adjudicate and analyse it to answer the question.
- ProspectiveFollow forward on ECS®.
Longitudinal cohorts, PASS/PAES, observational registries and patient support programmes. The data is born with the study, captured in the same ecosystem as your clinical trials.
- AmbispectiveOne protocol, both directions.
One arm looks back into the EHR, one arm follows forward on ECS®, under a single protocol, a single consent framework and a single audit trail.
Design-agnostic. The evidence question decides the design.
The journey follows the prescribed treatment.
In real-world studies the therapy is chosen by the clinician, ECS® reconfigures visits, ePRO cadence and device streams around what is actually prescribed.
- Treatment-aware branching
Arms activate from the regimen captured at baseline.
- Dynamic cadence
ePRO, televisit and device frequency follow the therapy's rhythm.
- Live re-routing
Dose changes and switches reshape the rest of the journey.
Method-first, methodology-defensible.
Longitudinal by design. Clinical by source.
Disease, product, exposure and safety registries, built to last.
Designed and run on ECS® with a longitudinal data model, reusable consent, governance for regulators and payers, and outputs ready for publication or HTA.
- Disease & rare-disease registries
- Product, exposure & pregnancy registries
- Safety & post-authorisation surveillance
- PSP-linked registries with consent built in
The electronic health record as a first-class evidence source.
On ECS®, Deep Dialogue turns unstructured hospital records into eCRF fields, mapped to standard ontologies and audit-trailed. Across our EHR-ready site network we activate feasibility, chart review and retrospective or ambispective studies with structured access to clinical data, under protocol, ethics and DPIA.
- Feasibility & cohort scoping from real records
- Retrospective chart review, adjudicated
- Ambispective designs joined on one protocol
- GDPR-compliant governance, site by site
Deep Dialogue Technology
From electronic health records to analysis-ready evidence.
Retrospective, prospective and ambispective studies still start from records built for care. Deep Dialogue reads them, understands them and turns the parts that matter into structured, monitor-ready data on ECS®.
- 01Connect
Secure link to the site's EHR or hospital data source, scoped to the study protocol.
- 02Listen
Study-specific NLP algorithms identify only the variables the protocol needs, no bulk dump, no noise.
- 03Translate
Selected records are converted into eCRF fields, mapped to standard ontologies.
- 04Capture
Data lands directly in ECS® EDC as smart data, audit-trailed and ready for monitoring and analysis.
Monitors spend their hours on judgement calls.
Real-world evidence starts with real people who choose to share their lives with research.
Patients, caregivers and citizens are the co-authors of every RWE study. Their consent, their continuity and their lived experience are what turn routine data into evidence a regulator, a payer and a clinician can trust.
Generate RWE that holds up.
Bring us your evidence question. We'll design the registry, PSP or observational study, in the same ecosystem your clinical data already speaks.