Koneksa Solutions
Digital Biomarkers That Decode the Complexity of Human Health
From step counts to speech patterns, Koneksa’s validated algorithms translate multimodal sensor data into reliable, regulatory-grade digital biomarkers remotely, consistently, and at scale.
235+
Validated digital measures
30+
Measurement concepts
100%
Device-agnostic by design
85+
Peer-reviewed publications
Why it Matters
Sensor
Algorithm
Digital Measurement
Insights
Algorithm
Digital Measurement
Insights
Smarter Data, Better Decisions
- Modern clinical trials generate data from many sources including smartphones, wearables, and patient-reported tools. Koneksa’s validated algorithms are the connective tissue, transforming raw, real-world data into sensitive, regulatory-grade digital biomarkers.
- Our digital biomarkers quantify symptoms traditionally assessed subjectively, such as tremor, sleep, gait, speech, and cognitive function, improving signal detection and trial efficiency across therapeutic areas including Parkinson’s disease, oncology, and respiratory conditions.
Not a Device. Not Just a Platform.
Validated Science.
Device-agnostic:
Our measures run on any device that captures the right data type. You’re never locked into a single wearable or vendor ecosystem.
Validated end-to-end:
Every biomarker is backed by sensor verification, usability evaluation, and analytical validation, evidence that supports publications and regulatory submissions.
Full-stack:
From capture through algorithm to analysis-ready endpoint, one accountable partner. No stitching together device vendors, algorithm shops, and ePRO providers.
From Sensor Signal
to Validated Endpoints
Digital biomarkers are only as strong as the evidence behind them. Koneksa’s end-to-end service takes a measurement concept from device selection through validated, submission-ready endpoint:
Device Evaluation
Ensuring the right fit before you invest
Rigorous assessment of hardware reliability, software functionality, and validation evidence, so only viable, scalable solutions move forward.
Regulatory Evaluation
De-risking your path to compliance
510(k)/CE verification, vendor qualification (QMS), and risk review via sources like the MAUDE database in alignment with FDA, CE, and global standards.
Verification & Validation
Generating evidence and trust
Sensor verification, usability evaluation, and analytical validation of outputs, generating data that supports publications and regulatory submissions.
Learn more in our Digital Biomarkers FAQBacked by Our
Backed by Our
Digital Measurement Framework
Every Koneksa digital biomarker is built on our digital measurement framework, developed for real-world clinical research. We support a full spectrum of digital data capture, from passive wearables to structured tasks, powered by our advanced algorithms:
|
Concept |
Measure |
Example Devices |
|---|---|---|
Gait & Mobility |
Step length, gait speed, stride period, freezing index |
Accelerometry devices (e.g., ActiGraph CPIW, iPhone) |
|
Turn Detection | Turn angle, duration, rate | Accelerometry devices |
Upper Limb Function | Pronation/supination count, rate, smoothness | Wearable accelerometry devices (e.g., ActiGraph CPIW, Empatica Embrace) |
|
Sleep Analytics |
Wake after sleep onset, total sleep time, efficiency | Wearable accelerometry devices (e.g., ActiGraph CPIW, Empatica Embrace) |
|
Voice Biomarkers |
Speech variability, pauses, articulation, pitch | Smartphone voice capture |
Tremor Biomarkers |
Peak tremor frequency, tremor energy | Accelerometry devices |
|
Finger Dexterity | Number of taps, tapping speed, tap regularity |
iPhone |
Cardiac Function |
Mean heart rate, heart rate variability (e.g., RMSSD) | PPG devices (e.g., Empatica Embrace Plus, Corsano) |
Gait and Mobility
Measure:
Step length, gait speed, stride period, freezing index
Example Devices:
Accelerometry devices
(e.g., ActiGraph CPIW, iPhone)
Turn Detection
Measure:
Turn angle, duration, rate
Example Devices:
Accelerometry devices
Upper Limb Function
Measure:
Pronation/supination count, rate, smoothness
Example Devices:
Wearable accelerometry devices
(e.g., ActiGraph CPIW, Empatica Embrace Plus)
Sleep Analytics
Measure:
Wake after sleep onset, total sleep time, efficiency
Example Devices:
Wearable accelerometry devices (e.g., ActiGraph CPIW, Empatica Embrace Plus)
Voice Biomarkers
Measure:
Speech variability, pauses, articulation, pitch
Example Devices:
Smartphone voice capture
Temor Biomarkers
Measure:
Peak tremor frequency, tremor energy
Example Devices:
Accelerometry devices
Finger Dexterity
Measure:
Number of taps, tapping speed, tap regularity
Example Devices:
iPhone
Cardiac Function
Measure:
Mean heart rate, heart rate variability (e.g., RMSSD)
Example Devices:
PPG devices (e.g., Empatica Embrace Plus, Corsano)
Learn more about these measurements and others:
Flexibility Without Device Constraints
Our digital measures were developed with a device agnostic framework.
- This means that our measures can be calculated prospectively or retrospectively on any device that captures the appropriate data type.
- For example, we retrospectively used the mPower dataset to compare our digital measures in people with Parkinson’s disease and healthy controls.
Our Digital Measurement Catalog
Designed for Clinical Precision and Flexibility
We combine sensor inputs, mobile technology, and intelligent algorithms across four digital measurement types:
Coached Assessments
Used when consistent measurement is critical, such as for vital signs or tasks that follow a standard protocol.
2Concepts
40+Measures
eDiaries
and ePROs
Ideal for high-frequency at-home capture. Configurable for scheduling and context-driven reporting.
21Concepts
35+Measures
Instructed
Tasks
Designed to support a wide range of therapeutic areas and clinical applications through guided interactions.
6Concepts
100+Measures
Single / Multi- sensor Devices
Integrated device options tailored by study needs, balancing accuracy, wear time, and participant experience.
4Concepts
60+Measures
Proven in Practice:
Parkinson’s Disease
Core Koneksa assessments:
- Gait & Balance
- Postural, resting and kinetic tremor
- Pronation/Supination
- Finger Tap
Optional 3rd party integrated assessments:
- Speech
- Cognition
Wrist-worn passive measures:
- Gait
- Walk detection
- Physical activity
- Sleep
PROs:
- Configured to clinical research requirements
- Ex: sleep quality & duration
Our algorithm-driven approach replaces the difficult task of subjectively rating tremor, gait, and balance in clinic. Core Koneksa assessments combine with wrist-worn passive measures, configurable PROs, and optional third-party speech and cognition assessments for a complete picture of disease.
