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Company description

Koneksa Health is a clinical data innovation partner that accelerates drug development by powering evidence generation across clinical trials and real-world settings. The company integrates traditional biomarkers with digital biomarkers, wearable sensors, and mobile technology to uncover new signals in complex, multimodal datasets — going beyond endpoints to deliver insights that improve trial design, accelerate decision-making, and deepen understanding of disease.

Originally a pioneer in digital biomarkers, Koneksa has evolved into a full-service platform company supporting end-to-end study design and execution. Backed by expert teams in science, regulatory affairs, and data analytics, Koneksa serves leading biopharma companies, CROs, and academic research consortia across more than 50 clinical programs spanning neurology, oncology, respiratory, and rare diseases.

Core Solutions and Services

• Clinical Trial Design and Execution: Koneksa designs and executes remote-first, patient-centric trials that enhance participant retention, reduce burden, and unlock richer clinical insights.
• Professional Services: Scientific, clinical, and regulatory experts partner with sponsors to design, implement, and validate digital strategies across the full drug development lifecycle.
• Digital Endpoints: Continuous, real-world data is captured using validated measures built for regulatory confidence and scientific rigor.
• Analog Endpoints: Traditional clinical measures — including lab tests, imaging, and functional assessments — are integrated into a unified data stream alongside digital biomarkers to create a holistic, multimodal evidence package.
• Data Science, AI/ML, and Statistical Services: Advanced analytics, machine learning models, predictive algorithms, and rigorous statistical analysis are applied to complex longitudinal datasets to optimize clinical decision-making.
• SaaS Platform Licensing: A flexible, sensor-agnostic platform can be deployed to operationalize digital endpoints, with optional modules for data science consulting, custom algorithm integration, and regulatory reporting.

Multimodal Data Platform Capabilities

• Designs and integrates multimodal data from both traditional and digital clinical studies, including outputs from mobile apps, wearables, and conventional trial measures, into scalable pipelines for analysis, export, and new signal discovery.
• Supports flexible model engagement: sponsors can co-develop a model with Koneksa, license Koneksa's proprietary models, or bring their own models to the platform.
• The platform is designed to support regulatory-aligned evidence generation throughout the clinical development process.
• Frequent, high-precision digital measures reduce noise and enhance statistical power and results clarity.
• Efficient data pipelines accelerate trial timelines and support faster decision-making.
• Smarter participant stratification and eligibility criteria enable patient-enriched trial design.
• Seamless digital integration improves study participant adherence and data completeness.

Outcomes and Impact

• Novel algorithms enable earlier and more accurate prediction of disease progression and patient trajectories.
• Supported over 50 clinical programs across neurology, oncology, respiratory, and rare diseases.
• Evidence generation outputs include peer-reviewed publications, scientific posters, and intellectual property.
• Trusted by leading biopharma organizations, CROs, and academic research consortia.

Featured Case Study: Predicting Parkinson's Risk

• In partnership with the Michael J. Fox Foundation and Verily, Koneksa supported an initiative to detect early Parkinson's risk using smartwatch-derived features.
• The dataset encompassed 32 TB of smartwatch data — 150,000 files from 350 participants — covering activity, gait, vital signs, and sleep.
• Koneksa's 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.
• Scaled compute infrastructure enabled 10–20x faster delivery of extracted insights.

Scientific Publications and Research Areas

• Koneksa has published peer-reviewed manuscripts on the impacts of digital measures in Parkinson's disease-modifying therapy trial design.
• Research includes a proposed multi-domain digital model for capturing functional status and health-related quality of life in oncology.
• Additional published work covers patient-centric models for vaso-occlusive crises in sickle cell disease, among other therapeutic areas.

Koneksa Health combines a proprietary technology platform with deep scientific and regulatory expertise to redefine how clinical evidence is generated — digitally, remotely, and intelligently — enabling sponsors to make smarter, faster decisions throughout the drug development process.

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Software attributed to Koneksa

• Koneksa PlatformView
• Advanced Modeling & Analysis ServicesView

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