The Koneksa Platform unifies data capture, storage, processing, and insight in a
single validated environment, built for the scale, rigor, and compliance clinical development demands.
Koneksa Platform
In-clinic data. Captured anywhere.
The Koneksa Platform is a sensor-agnostic platform that turns continuous, real-world patient data into regulatory-grade digital endpoints across every phase, therapeutic area, and device.
One sensor-agnostic platform
to capture, transform, and analyze high-frequency health data remotely, powered by a patented software engine and a patient-centric mobile app deployed in trials across 55+ countries.
One Platform, From First Signal to Submission-Ready Dataset
Sensor-Agnostic Capture
Collect from consumer and medical-grade wearables, mobile sensors, ePROs, eDiaries, speech files, and cognitive and motor tasks, through one patient-facing app.​
Digital Biomarkers + Endpoints
Translate continuous data including gait, tremor, heart rate, sleep, speech, and spirometry, into objective, validated, regulatory-ready measures
Secure, Centralized Data Lake
AWS S3-based storage for complex longitudinal data. GxP-compliant and built as a single source of truth for the whole study.
Source-Agnostic Processing
Scalable ETL pipelines normalize data from any vendor or device, with audit-ready transformation logs and high-throughput turnaround.
Regulatory-Grade Curation
Automated formatting and export to SDTM and ADaM structures, with no-code schema configuration and full end-to-end traceability.
Real-Time Insight + AI Exploration
No-code dashboards and a plain-language, AI-assisted query interface let any stakeholder monitor adherence and explore trends live.
Two connected experiences.
One system of record.
The platform meets each user where they are: a mobile app in the patient’s hand, and a web application for the teams running the study.
Patient View:
The Mobile App
Patients complete guided assessments, submit ePROs and eDiaries, and sync wearable and device data from home supported by in-app videos, tutorials, and guides that keep participation simple and adherence high.
Both draw from the same validated data, so everyone works from a single source of truth.
Sponsor + Site View:
The Web Application
Study teams create participants and activate devices, then monitor compliance, adherence, and incoming measures in real time, with no-code dashboards and reports that keep sites, sponsors, and data teams aligned.
From Raw Signal to Scientific Insight
We support you at any point in the trial lifecycle, from data ingestion and algorithm development to regulatory submission and real-time insight generation.
Capture
Wearables, sensors, app assessments, ePROs & eDiaries
Store
Secure, immutable, GxP-compliant data lake
Process
Source-agnostic ETL & regulatory-grade curation
Analyze
Dashboards, models & submission-ready outputs
A validated measurement catalog,
configured to your study.
The platform supports a broad spectrum of digital measures selected and configured to fit therapeutic area, trial phase, and data-collection strategy.
Coached Assessments
40+
MEASURES
For tasks where consistency is critical, such as vital signs and standardized protocols.
Instructed Tasks
100+
MEASURES
For tasks where consistency is critical, such as vital signs and standardized protocols.
eDiaries + ePROs
35+
MEASURES
High-frequency at-home capture, configurable for scheduling and context-driven reporting.
Single / Multi-Sensor Devices
60+
MEASURES
Integrated device options balanced for accuracy, wear time, and participant experience.
Any Device,
Study-Ready, Faster and with Less Risk
Integrating digital health devices takes more than hardware selection. The platform is vendor-agnostic and backed by an end-to-end framework that makes devices technically sound, usable, connected, and operationally supported across global trials.
Vendor-agnostic integration including Apple, Ametris, Empatica, Corsano, and more
Device and regulatory evaluation, including 510(k) / CE verification and vendor qualification
Verification and validation that generates evidence for submissions and publications
Built on a compliant, scalable foundation
Immutable, AWS S3-based data lake supporting CSV, JSON, Parquet, AVRO, and audio formats
Machine learning model training at scale, with support for proprietary and third-party models
Aligned to 21 CFR Part 11, GCP, and global quality and compliance standards
Hosted by Koneksa or deployed in your own cloud
Licensed how you work, modular or end-to-end.
The platform is decoupled by design. License only what you need, scale from pilot to global program, and run it your way
License the Platform
Deploy the SaaS platform to operationalize digital endpoints and manage your own remote studies, with optional modules for data science and reporting.
Managed or Self-Hosted
Use Koneksa’s fully managed infrastructure, or license platform modules for internal deployment in your environment.
Bring or Build Your Model
Bring your own algorithm, license from Koneksa's catalog, or co-develop and validate novel digital measures with our scientists.
Add Expert Services
Layer in scientific, regulatory, and biostatistics support when you want it; never a prerequisite to using the software.
Proven where it matters
13+
Years Pioneering Remote Evidence
20+
Therapeutic Areas Supported
50+
Clinical Programs Supported
55+
Countries Supported
Data that's ready for what comes next
Because platform data is curated and traceable from the start, it flows cleanly into submission.
Pair it with Lodestar™, Koneksa’s intelligent submission software, to move from EDC to FDA- and EMA-ready submission in one auditable workflow.
