WornWell Bio
Biostatistics for wearable motion & heart-rate data in clinical trials.
We turn wearable motion and heart-rate data into clinical-grade, defensible endpoints. Get clarity on which measures are worth tracking, how to clean them, and how to model them, so every number holds up under review without slowing your trial down.
What we do
Defensible endpoints from a deluge of messy, high-volume sensor data
Wearable adoption in trials is climbing at a 20.2% CAGR, with more devices, more data, and more candidate endpoints every year. Getting on board was the right call. But collection alone doesn't pay off: the ROI is in cleaning, modeling, and defending that data well enough to hold up to reviewer and regulatory scrutiny. Recent FDA guidance on digital health technologies opened the door to wearable data in clinical investigations; most teams now have the data, but not the specialized statistical capacity to make it count. We close that gap directly, or build it into your team.
- Statistical Analysis Plans — wearable/digital endpoints aligned with ICH E9(R1) estimands and FDA digital-health guidance, including protocol and literature review to ground endpoint choices
- Data cleaning & QC — wear-time, valid-day rules, artifact filtering, compliance/data-yield reporting, and validation programming services
- Statistical modeling & analysis — the right longitudinal and repeated-measures models for sensor endpoints, by specialists fluent in the measures
- Clinical anchoring & RWE — relate digital endpoints to established clinical scales and patient-reported outcomes (PROs), with EHR and claims experience
- Reporting & manuscripts — analysis-ready datasets, statistical tables and figures, manuscript preparation and review, and clinical interpretation of results
- Training & enablement — results readouts, webinars, and hands-on training so your team can run wearable-endpoint analysis with our guidance
Who we work with
Built for clinical and research teams
Pharma & biotech
Wearable and digital endpoints, from endpoint definition and SAP through data cleaning & QC, primary analysis, and submission support.
CROs
Specialist capacity for wearable endpoints without adding headcount. Hand us the sensor-data work to deliver to your SOPs, or bring us in to guide your team and build the capability in-house.
Academic medical centers
Rigorous, reproducible analysis and publication support, with the same trial-grade methodology applied to investigator-initiated and grant-funded research.
How engagements work
Clear scope, defined price, no surprises
Scope call
A short call defines the problem, the data, and the deliverables.
Proposal & review
A written proposal with fixed scope and timeline, for your review and approval.
Contracting
A signed agreement fixes scope, timeline, and price, with NDA and de-identified-data terms in place before any data changes hands.
Execution
Reproducible, validated work in SAS and R, aligned with FDA digital-health guidance.
Deliverables
Analysis-ready data, tables and figures, manuscript methods, or a final report with clinical interpretation.
Devices & platforms
Fluent in many, quick to adapt to any
Wearable and sensor hardware varies widely in sampling, exports, artifacts, and validation evidence, and we work across all of it. We bring hands-on experience with platforms like APDM Opal, Garmin, Fitrockr, Empatica, and Koneksa, and we're ready to take on whatever device your trial runs on.
- APDM Opal
- Garmin
- Fitrockr
- Empatica
- Koneksa
- McRoberts DynaPort
- Biosensics
- Ametris (formerly Actigraph)
- activPAL
- Axivity
- WHOOP
- Oura
- Fitbit
- Apple Watch
About
Built on 7 years across wearable trials and real-world data
WornWell Bio is led by founding biostatistician Daniel Muzyka, M.Sc., who spent several years working directly on the statistical analysis of data from the APDM Opal precision motion platform across CNS diseases, in collaboration with the internationally recognized balance and gait group led by Dr. Fay Horak at OHSU.
The team has designed and owned SAPs for wearable motion and heart-rate data in prospective randomized trials, from compliance reporting through primary analyses and publication-ready manuscripts. That experience also spans electronic health records, insurance-claims data, and clinical outcome scales, bringing a real-world-evidence perspective alongside the wearable work. We work in SAS and R and produce deliverables aligned with FDA digital health technology guidance.
M.Sc. Biostatistics · SAS Certified · US-based (remote).
Selected publications
Peer-reviewed papers in JACC, Movement Disorders, and JCO Precision Oncology, plus conference abstracts and presentations.
- Shah VV, Muzyka D, et al. "The Potential of an Instrumented 6-Minute Walk Test." Journal of the American College of Cardiology, 2026.
- Shah VV, Muzyka D, et al. "Digital measures of postural sway quantify balance deficits in spinocerebellar ataxia." Movement Disorders, 2024.
- Shah VV, Muzyka D, et al. "Chemotherapy-Induced Peripheral Neuropathy and Falls in Cancer Survivors." JCO Precision Oncology, 2024.
- Casey HL, Shah VV, Muzyka D, et al. "Standing balance conditions and digital sway measures for clinical trials of Friedreich’s Ataxia." Movement Disorders, 2024.
Contact
Let's scope your wearable data project
A short call defines the work and lets us put together a quote. We offer fixed-price projects, time-and-materials, monthly retainers, prepaid hour blocks, and custom scopes.
Independent biostatistics consultancy. De-identified data only. SOPs, NDA, and references available on request.
Direct
Email: daniel@wornwellbio.com
LinkedIn: Daniel / WornWell Bio
Published research: Google Scholar profile