Koneksa Platform

The Koneksa Platform is an end-to-end clinical operations and SaaS solution designed to support the next generation of digital clinical trials. Built for pharmaceutical, biotech, and academic research organizations, Koneksa combines a patented software platform, a patient-centric mobile app, and expert scientific and operational services to enable the capture, transformation, and analysis of high-frequency health data — generating clinical-grade insights remotely. The platform supports studies across more than 55 countries, with a focus on validated digital biomarkers and electronic clinical outcome assessments (eCOAs).

Koneksa supports the full lifecycle of digital clinical trials, from early study concept and endpoint selection through execution, data modeling, and final analysis. Its platform integrates wearables, mobile assessments, and ePROs to enhance both decentralized and traditional analog clinical trials across a broad range of therapeutic areas.

Core Platform Capabilities

• Flexible Study Design: Configurable architecture to accommodate diverse protocol requirements across interventional, observational, and natural history studies.
• Turnkey Device Integration: Evaluation, qualification, provisioning, and seamless integration of wearable devices and sensors into the Koneksa platform for study use.
• Robust Algorithm Engine: Proprietary algorithms and model development spanning neurology, cardiology, respiratory, rare diseases, and more.
• Data Capture: Supports a wide range of sensor modalities including rotation, flow volume, superficial temperature, heart rate, SpO2, screen touch, and movement.
• Koneksa Mobile App: Patient-centric application enabling remote data collection through wearables, mobile assessments, and ePROs.
• Real-Time Data Insights: Continuous monitoring and analysis of high-frequency health data to generate actionable clinical insights.

What Koneksa Delivers

• Study Design & Advisory: Scientific advisory boards, key opinion leader (KOL) input, endpoint selection, feasibility analysis, and early concept design.
• Execution Services: ePRO translation, IRB submissions, device kitting, participant training, and 24/7 multilingual support.
• Supporting Studies: Pilot, validation, usability, and retrospective studies to support endpoint development.
• Device Integration: Full device lifecycle management from evaluation and qualification through provisioning and platform integration.
• Data Modeling & Insights: Development of proprietary algorithms and models across multiple therapeutic areas including neurology, cardiovascular, and respiratory conditions.

Clinical Endpoint Development

• Koneksa delivers expert support across the full lifecycle of endpoint development, from portfolio prioritization to final execution.
• Cross-functional services are designed to close the gap between clinical need and validated digital evidence.
• Integrated services advance digital trial success by combining scientific rigor with operational expertise.

Digital and Analog Measures Supported

• Wearable sensor data, including tremor, gait, ECG, and activity monitoring
• Mobile, cognitive, and motor function tasks
• Speech and voice biomarkers
• Electronic patient-reported outcomes (ePROs) and symptom diaries
• In-clinic and remote clinician-assessed video capture
• Continuous compliance and adherence monitoring

Therapeutic Area Expertise

• Neurology: Parkinson's disease, multiple sclerosis, and other CNS indications using mobile assessments, voice analysis, and wearable-based motor tracking. Over a third of Koneksa's portfolio has focused on neurological conditions, including nine Phase 2/3 trials.
• Cardiovascular: Digital data integration in heart failure and cardiomyopathies, including dilated cardiomyopathy.
• Oncology: Remote symptom monitoring and real-world data capture in solid tumors, lung cancer, and multiple myeloma, supporting both interventional and observational studies.
• Respiratory: Real-world monitoring in asthma and COPD, including inhaler adherence and breathing pattern analysis, as well as idiopathic pulmonary fibrosis.
• Infectious Diseases: Remote patient monitoring during and after treatment for COVID-19 and similar conditions, measuring activity, sleep, and vital signs in the home setting.
• Musculoskeletal Conditions: Development and evaluation of novel digital measures for adult and pediatric populations, including achondroplasia and skeletal disorders.
• Other Conditions: Digital solutions for hemophilia, paroxysmal nocturnal hemoglobinuria, schizophrenia, atopic dermatitis, hepatic insufficiency, and more, capturing disease-specific symptoms alongside physical activity, sleep, and vital signs.

Types of Studies Supported

• Phase 1–3 interventional trials
• Longitudinal, observational, and natural history studies
• Pilot, usability, and validation studies for endpoint development
• Healthy control measure evaluations and comparator dataset development
• Decentralized and hybrid clinical trial models

Koneksa's platform and services are deployed globally across more than 55 countries, supporting leading pharmaceutical, biotech, and academic institutions. The platform is backed by a growing body of abstracts, patents, and publications, reflecting Koneksa's commitment to advancing scientifically rigorous, operationally robust digital clinical research.