Wearables for clinical trials

Quick answer: for clinical trials, buy data access and operations you can defend, not a consumer score. Put raw signal rights, exports, configuration, and wear-time reporting in the RFP before you argue about industrial design.

The trial question is data access

After last patient out, the only asset that matters is what you can still analyze. If the vendor's cloud will only show a recovery index, your statistician cannot reopen the optical record. If exports expire into a proprietary viewer, your archive is a screenshot.

Trial teams do not need another wellness app. They need a contract with the signal.

What to put in the RFP

Raw and derived channels

Spell the channels:

• Raw PPG waveform when morphology or re-derivation is in scope
• Beat-to-beat intervals when timing analyses matter
• Motion for artifact context
• Skin temperature if your endpoints use it
• Which wavelengths (green, red, infrared) must be on

For Sensor Bio, raw PPG downloads expose unfiltered green, infrared, and red amplitudes with nanosecond timestamps when those channels are enabled. Sample rate is organization-configurable at 25, 50, or 100 Hz. Raw capture is off until you turn it on. Write the on-switch into site initiation, not into a late protocol amendment.

Export and API contracts

Ask for:

• Formats (CSV/JSON at minimum)
• Pull windows and rate limits
• REST or cloud-to-cloud automation
• Mobile SDK behavior if the phone mediates sync
• Retention and re-download rules after the study ends

Sensor Bio's documented path includes REST at https://api.getsensr.io/v1/, iOS and Android SDKs, OAuth 2.0 consent flows for third-party apps, computed downloads over 1-30 day windows, and raw downloads over 1-7 day windows. Super Admin role is required for those downloads. Put role design in your study ops plan.

Configuration before first enrollment

If you cannot set sample rate, duty cycle, and raw export before the first kit ships, you are accepting vendor defaults as your protocol. Prefer a device profile applied once across the cohort. See how to configure a research wearable.

Wear-time and missingness reporting

Demand operational views for hours worn, charge gaps, and sync failures. Missingness is a study outcome driver. It should not be a surprise in the CSR.

Evidence questions without overclaiming

When a vendor shares validation materials, score the methods, not the adjective on the slide:

• What was the reference?
• Who was in the sample, and under what motion?
• Was each endpoint validated separately (pulse rate vs interval timing vs other derived metrics)?
• How were artifact windows and missingness handled?
• Does the claim match a general wellness product posture, or does it imply diagnosis?

Sensor Bio V2 is a general wellness device, not FDA cleared for diagnosis. Trial and research programs should keep product language inside research and program design. Do not treat disease-screening abstracts in a literature pack as a product claim for the current device.

For applied optical context, use Sensor Bio's on-site PPG for wearable products overview. Pair it with your own protocol-specific validation plan.

Ops realities that kill cohorts

Battery under default settings is not battery under study settings. Sensor Bio V2 comparison figures list up to 7 days under default settings and up to 2 days under max recording settings, with much shorter on-device storage at max recording. High-rate raw capture needs a charging and sync SOP participants will actually follow.

Also plan for:

• Kit logistics and replacements
• Who holds API keys
• How sites escalate a device that will not sync
• Privacy, consent, and whether a BAA discussion applies to your contracting model (Sensor Bio states willingness to discuss BAAs through the account team; confirm current compliance status during vendor due diligence)

How Sensor Bio fits the buyer job

Sensor Bio positions as wearable infrastructure: hardware plus SDK/API plus program tooling for teams that build health products and run studies. The buyer-relevant facts are configurable capture, raw PPG when enabled, documented export windows, and quiet CTAs into engineering rather than a consumer app upsell.

Use the shorter research wearable checklist in screening calls. Send partners to raw PPG access when they are ready to wire ingestion.

Next steps

Talk to engineering. Request signal access. Bring your endpoints, expected wear schedule, and the systems that must receive the files.

Claims note

This guide is educational for research and program design. It does not claim Sensor Bio V2 is FDA cleared, does not assert diagnostic performance, and does not imply RPM billing eligibility.