Capture layer · Module 05Connected devices
Objects that measure, in dialogue with ECS®.
Wearables, biosensors and home devices stream vitals, adherence and behavioural signals into ECS®; ECS® pushes back thresholds, prompts and quiet reminders. Device data is contextualised against protocol thresholds and participant guidance is nudged accordingly, all inside the same audit trail.
A dialogue with the participant.
Devices push in; ECS® pushes back, inside the same audit trail, framed by ISO 14155 and the applicable MDR/IVDR class of each device.
- Wearables
Activity, sleep, HR, SpO₂.
- Biosensors
CGM, ECG, respiratory, temperature.
- Home diagnostics
Spirometry, BP, pulse-ox, weight.
- Smart pillbox
Dose opened, missed, late.
- Thresholds
Protocol-defined windows and alerts.
- Prompts
Just-in-time nudges via LucaH®.
- Guidance
Study-team escalation when needed.
- Reminders
Quiet, snoozable, translatable.
Purpose-built, module by module.
Consumer and clinical-grade wearables, activity, sleep, heart-rate, SpO₂, streamed into ECS® against protocol-defined windows and thresholds.
Continuous glucose, ECG patches, respiratory and temperature sensors, signals flow into structured, analysis-ready fields.
Adherence captured objectively, dose opened, dose missed, dose late, with prompts back to LucaH® before a protocol deviation forms.
Home-use diagnostic devices (spirometry, BP cuffs, pulse-oximeters, weight scales) integrated with consented context and QC checks.
Signals sampled at the cadence the protocol requires, with clinical-decision-support thresholds routed to the right investigator.
Standards-based pairing (BLE, HL7 FHIR device profiles), devices provisioned to each participant via LucaH®.
Devices push data in; ECS® pushes back thresholds, reminders and behavioural nudges, closing the loop inside the same workflow.
Bring-your-own-device where the protocol allows; study-provisioned hardware where the protocol requires it. Same audit trail either way.
Regulatory & standards frame.
The regulatory and standards backdrop this module is designed against.
Clinical investigations of medical devices for human subjects.
Device class recognised per protocol, CE and UKCA declarations kept in eTMF.
Standardised device identity, provisioning and pairing metadata.
Standards-based pairing to hardware provisioned to each participant.
Cybersecurity guidance for medical devices and connected accessories.
Where AI interprets device signals, transparency and human oversight apply.
Built to be handed to a regulator, with regional data residency in the sponsor's jurisdiction.
The rest of ECS®.
Send the case report form you already have.
We map it into ECS® and show the edit checks, the health record ingestion and the export your statistician will actually receive.