Layers

Objective + subjective

Wearable + ePRO + eCOA

Alignment

Visit-window

Same protocol clock for sensor + diary

Output

Unified outcomes

One analyzable dataset, not two

Objective + subjective evidence, fused

Endpoint + ePRO Fusion
for Clinical Trials

Endpoint + ePRO fusion is not just running both modalities in parallel. It is combining wearable-derived endpoints with symptom diaries and ePRO instruments into a single, time-aligned, analysis-ready outcomes layer — so the patient's experience and the sensor's measurement can be analyzed together.

Time-aligned · Provenance-preserving · Analysis-ready

EPRO
HRV
SLEEP
FUSION

Fusion Workflow

Capture → Align → Fuse → Analyze

Will my diary entries actually be compared to my heart rate?
Yes. Fusion aligns your diary on the same protocol clock as the wearable, so the two move together in the analysis.
That's how the study can ask: 'did how you felt match what your sensors showed?'
Fuse the experience and the measurement ePRO + wearable + eCOA

What 'Endpoint + ePRO Fusion' Really Means

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

Wearable digital endpoints and ePRO data fused into a unified outcomes layer

Why Most 'Both' Studies Aren't Really Fused

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.

Different clocks

ePRO timestamps and wearable timestamps drift, so pairing entries to sensor windows requires guesswork.

Different schemas

One modality lives in EDC, the other in a wearable warehouse. Joining them is its own project.

Lost provenance

Cross-modality joins drop device, firmware, and algorithm context.

Arbitrary pairings

Without protocol-aligned pair definitions, fusion produces correlations that don't mean what they look like.

No QC awareness

Fused values mix sensor data flagged for quality with self-reports — and the analyst can't tell which is which.

Late integration

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.

Delve Fusion vs Running ePRO and Wearable in Parallel

Parallel data collection

  • ePRO in EDC, wearable in vendor system
  • Different time bases
  • Manual joins at analysis time
  • No QC propagation across modalities
  • Fusion happens after the trial

Delve fused outcomes

  • Single outcomes layer for both modalities
  • Same protocol clock and windows
  • Pre-defined, protocol-aligned pairings
  • QC flags preserved on both sides
  • Fusion live throughout the trial

Real fusion is decided before the protocol is written — not after the data is collected.

What Strong Endpoint + ePRO Fusion Includes

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

Fused outcomes layer combining wearable digital endpoints and ePRO instruments

Clinical Questions Fusion Makes Testable

Once ePRO and digital endpoints share a clock and a schema, the protocol can ask questions neither modality could answer alone.

Symptom ↔ activity

Does self-reported pain track changes in gait speed over weeks?

Sleep self-report ↔ actigraphy

Does perceived sleep quality align with measured sleep continuity?

Mood ↔ HRV recovery

Do mood diary patterns correspond to HRV trends?

Adherence ↔ engagement

Does medication-diary adherence track with wearable engagement?

Symptom flare ↔ respiratory signal

Does a flare in self-report align with a measurable respiratory change?

Quality of life ↔ daily activity

Does a QoL instrument trend with total daily activity?

Fusion makes those questions testable — and answers them with one analyzable dataset.

FAQ

Can we fuse our existing ePRO instrument with wearable endpoints?

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.

Does fusion affect data quality?

Fusion preserves quality. Both modalities keep their QC context, and the fused view shows which side of a pair has any flagged values.

When does fusion happen in the workflow?

Continuously, as data arrives. Fused outcomes are available on dashboards during the trial and in submission packages at the end.

Make the Patient Experience and the Measurement Move Together

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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