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Data, Models and Insights

Advanced Modeling and Analysis Services

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Turning Complex
Multi Modal Data Into Actionable Clinical Insights

Koneksa platform and wearable devices

Why Modeling Matters 

  • In modern clinical trials, digital biomarkers offer the promise of richer, more sensitive insights — but realizing this value requires more than raw data. It demands expert processing, advanced modeling, and scientific rigor.
  • Our full-service modeling and analytics solutions help sponsors unlock the full potential of digital data to accelerate development, improve trial design, and strengthen regulatory submissions.
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Our Services

Scalable
Data
Processing

We Developed Scalable, Cloud-Native Infrastructure for High-Throughput Sensor and Wearable Data Processing

  • Cloud-native pipelines handle terabytes of time-series data from wearables and sensors

  • Flexible architecture supports standard and custom algorithms across study designs

  • Outputs are structured, analysis-ready datasets for modeling and regulatory use

Statistical
and Machine
Learning Modeling

Our expert team designs and executes statistical modeling strategies tailored to study objectives:

  • ​Development of comprehensive Statistical Analysis Plans (SAPs)

  • Longitudinal modeling of disease progression

  • Assessment of test-retest reliability and other aspects of clinical validity

  • Machine learning model development for feature selection, risk scoring, and endpoint optimization

  • Power analyses to inform study design and optimize sample size​

Scientific Consulting
and Reporting

We partner closely with client teams to translate modeling results into strategic insights

  • Support for regulatory-facing documentation

  • ​Data visualization and interactive result exploration

  • Guidance on endpoint selection, adaptive design strategies, and predictive modeling

  • Ongoing collaboration to maximize commercial impact of digital biomarkers

Client Project Impact

Parkinson’s Risk Prediction 

In partnership with the Michael J. Fox Foundation and Verily, we supported an initiative to detect early Parkinson’s risk using smartwatch-derived features

  • The dataset included 32 TB of smartwatch data -

         (150,000 files from 350 participants).

  • Our team developed a composite machine learning predictor that effectively stratified individuals into high- and low-risk groups.

  • The resulting digital risk index predicted clinical test outcomes and supported identification of individuals at elevated risk for targeted intervention.

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Verily watch
  • Our scaled compute allowed 10 - 20x faster delivery of extracted insights

Data Sources

Extracted Physiological Features

Activity

Gait

Vital Signs

Sleep

Integrated Machine Learning Model

Development of Risk Index

Risk is Associated with Clinical Severity

ALS Progression

A leading biopharmaceutical company sought to determine whether digital biomarkers of motor function could detect  disease progression more rapidly and reliably than traditional PROs. 

  • The dataset comprised ~1.5TB of tri-axial accelerometry data (~30,000 files from 450+ participants).

  • Custom algorithms were integrated in to our cloud-native pipeline to extract gait, upper limb mobility, postural transitions, and daily activity measures.

ALS Progression Data Desktop
Digital measure device
  • The resulting measures demonstrated excellent reliability and sensitivity, enabling the sponsor to identify superior biomarkers and inform future digital strategy.

  • Our scaled compute allowed 10 - 20x faster delivery of extracted insights.

Data Sources

ALS therapy development institiute

Extracted Physiological Features

Upper Limb Mobility

Gait

Postural Transitions 

Activity

Progression Analysis of Digital Measures

Progression analysis

Reliable Metrics with Faster Detectable Change

Reliable metrics

PD Progression

In partnership with a top 10 pharmaceutical company, we deployed our neuroscience toolkit to support digital biomarker validation in Parkinson’s disease.

  • Our team successfully accommodated mid-study protocol amendments, reprocessing data with updated algorithms to ensure scientific rigor and consistency.

  • We processed 54 GB of accelerometry data (50,000 files from 100+ participants). 

  • Our scaled compute allowed 10 - 20x faster delivery of extracted insights.

PD Progression Desktop
Koneksa iPhone app

Data Sources

Data Processing Infrastructure

Raw Data

Controller

Status Data

Containers

Output Data

Extracted Physiological Features

Gait

Tremor

Activity

Dexterity

Models of Disease
Built on Our Digital Measures 

Model
Generalized capability
Other use cases

PD On/Off

Symptomatic levodopa dose response curve

Also applies to drugs for other neuro, pain, hypertension, ADHD, addictions etc.

PD risk score

Prognostic biomarker using known precursors to diagnosis

Other combinations of measures in in other indications may leverage same approach

PD Progression

Amplifying progression signal in slow variable progression

Palsies, cardiovascular disease, other neuro like HD, MS

Ambulatory function

Functional capacity at home in indications which reduce capacity

All Cardiovascular, HPP, Asthma, Knee OA

Neuro EEG

Prognostic biomarker using known precursors to diagnosis

EEG power spectrum analysis for neurologic changes before presentation, cardiac events prior to ischemia, signs before fever

ALS Progression

Isolating progression rate in variable population

Dementias, PSP, diseases without progression models e.g. lysosomal disorders

SCD Pain Crisis 

Objective measure detection of events

Asthma, COPD, migraine, epilepsy, ataxias, most autoimmune disorders

Abstract Background

Value Delivered

Across these and other projects, our modeling services have delivered clear value
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​Accelerated development timelines through

earlier, more sensitive disease signal detection​

  • ​Our scaled compute allowed 10 - 20x faster delivery of extracted insights, accelerating subsequent clinical study design.

Progression of digital measures more sensitive

than traditional PROs​

  • ​In the ALS progression tracking project, digital measures showed a significant increase in monthly change over time relative to the standard PRO

Data-driven protocol optimization, enabling

adaptive trial designs​

  • ​In simulated analyses comparing at-home versus in-clinic study designs, denser and more precise digital measures resulted in 68% fewer patients required per trial arm (Lavine et al., 2024).

​​Regulatory-grade outputs that support confident submissions and strategic trial decisions

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See the Power of Prediction in Action

Unlock real-world results from Koneksa’s Advanced Modeling & Analytics Services

 Let's Collaborate 

Whether your goal is to validate an existing measure, develop novel digital biomarkers, or extract new insights from complex data, our modeling and analytics team can help. 
Contact us to learn how we can support your next generation of digital clinical trials.
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