ECS® fits the systems you already run.
ECS® speaks open standards, documents every interface, keeps its validation evidence current, and can take over a study that has already started.
Open standards, documented interfaces
Built to connect. Every interface below is live, documented, and ready to validate.
Health records and hospital systems
HL7 FHIR and REST interfaces to hospital electronic health records, so source data is read where clinicians already write it. OMOP mapping for observational work.
Electronic data capture and case report forms
Run ECS® as the capture engine, or sit alongside an incumbent EDC and exchange structured data both ways. Exports in CDISC standards (SDTM-ready datasets, define files).
Laboratories and imaging
Central and local lab feeds with unit normalisation and reference range handling. Imaging and reading workflows attached to the visit they belong to.
Randomisation and supply
IRT and randomisation, with drug accountability and smart supply tracked against the same participant record used for consent and visits.
Devices and wearables
Biosensors, wearables and home devices onboarded per protocol, with thresholds pushed back out rather than raw streams dumped into a lake.
Sponsor systems
Safety databases, statistical environments and sponsor data lakes fed through documented APIs, with role-scoped access and full audit trail.
Built under a computerised system validation lifecycle
ECS® is specified, tested, qualified and released under a computerised system validation lifecycle. How the platform behaves is a controlled outcome of that lifecycle, not a claim made after the fact.
- Every release is specified, tested and formally qualified before it reaches a study.
- Requirements stay traceable from specification through test to the released build.
- Changes, deviations and corrective actions run through controlled workflows.
- Installation, operation and performance are qualified per environment.
- The audit trail is designed to 21 CFR Part 11 expectations and cannot be edited.
- Suppliers, hosting and data residency are qualified before any study data lands.
Moving a study that has already started
A migration mid-study is a data integrity exercise before it is a technical one. We run it as a controlled change, with the old system readable until the new one is proven.
- 01 · Assess
Current data model, open queries, consent versions and outstanding deviations mapped against the protocol as amended.
- 02 · Plan
Migration plan with acceptance criteria, reconciliation rules, a rollback position and the regulatory rationale written down before anything moves.
- 03 · Move
Data migrated with full lineage, audit trail preserved, and the legacy system kept read-only for the required retention period.
- 04 · Reconcile
Record-by-record reconciliation, signed off by data management and quality, with the report filed in the trial master file.
Three ways to work with ECS®
Pick the model that fits the team you already have.
Full-service with ECS®
Full-service, end-to-end on ECS®
Evidilya runs the study end-to-end on ECS®, from protocol to publication. One accountable partner.
- Fit
- A new evidence programme, Direct-to-Participant by design
- Scope
- Design → Reach → Conduct → Report
Full-service on your stack
Full-service on your systems, including FSP and advisory modalities
You keep your systems and your sites; our expert specialists run the study, or embed inside your team (FSP) for named functions, or advise as a defined consultative engagement.
- Fit
- An in-flight study, or a decision to de-risk before committing to one
- Scope
- Named functions: reach, monitoring, data, biostats, writing, advisory
ECS® licence
ECS® licence, technology-provider model
Your team runs the study; ECS® is the validated, supported virtual research ecosystem underneath. No full-service required.
- Fit
- Sponsor or CRO with in-house operations
- Scope
- ECS®, validation, training and governance
In full autonomy: your team builds the eCRF with validation rules, laboratory ranges and live preview; site activation and per-site enrolment run from day one, no technical intervention.
Ask about licensing →Send us your systems list.
Tell us what ECS® would need to talk to, and we come back with the interfaces, the standards used and what stays in your stack.