Layers
Objective + subjective
Wearable + ePRO + eCOA
Alignment
Visit-window
Same protocol clock for sensor + diary
Output
Unified outcomes
One analyzable dataset, not two
Fusion Workflow
Capture → Align → Fuse → Analyze
In clinical trials, endpoint + ePRO fusion is the layer that brings together objective sensor-derived endpoints and subjective patient-reported instruments into a single, time-aligned dataset. It is what allows a study to analyze pain alongside gait speed, sleep self-report alongside actigraphy, and symptom diaries alongside HRV recovery — without after-the-fact reconciliation.
Fusion is what turns 'we collected both' into 'we can actually analyze them together.'
Related pages: eCOA / ePRO · Digital Endpoints
Many studies collect ePRO and wearable data in parallel, but never actually fuse them. The data ends up in two databases that get reconciled post-hoc, badly, at analysis time.
ePRO timestamps and wearable timestamps drift, so pairing entries to sensor windows requires guesswork.
One modality lives in EDC, the other in a wearable warehouse. Joining them is its own project.
Cross-modality joins drop device, firmware, and algorithm context.
Without protocol-aligned pair definitions, fusion produces correlations that don't mean what they look like.
Fused values mix sensor data flagged for quality with self-reports — and the analyst can't tell which is which.
Fusion happens after the trial ends, so it can't inform decisions during the study.
If fusion isn't built in from the protocol, it's not really fusion — it's reconciliation.
Real fusion is decided before the protocol is written — not after the data is collected.
Fusion that holds up under analysis is built around the protocol's clinical questions, not just the available data streams.
Strong fusion produces a single dataset that can answer questions either modality alone cannot.
See related pages: Analytics · eCOA / ePRO · Endpoint Dashboards
Once ePRO and digital endpoints share a clock and a schema, the protocol can ask questions neither modality could answer alone.
Does self-reported pain track changes in gait speed over weeks?
Does perceived sleep quality align with measured sleep continuity?
Do mood diary patterns correspond to HRV trends?
Does medication-diary adherence track with wearable engagement?
Does a flare in self-report align with a measurable respiratory change?
Does a QoL instrument trend with total daily activity?
Fusion makes those questions testable — and answers them with one analyzable dataset.
Yes, in most cases. The instrument's response semantics and visit windows have to be compatible with the protocol's fusion definitions. We help map that during study setup.
Fusion preserves quality. Both modalities keep their QC context, and the fused view shows which side of a pair has any flagged values.
Continuously, as data arrives. Fused outcomes are available on dashboards during the trial and in submission packages at the end.
Delve combines wearable digital endpoints, ePRO, and eCOA into a single fused outcomes layer so the protocol can ask better questions and answer them faster.
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