Let Lodestar™ connect, validate, and package your regulatory submission; AI-assisted, human-approved at every step.
Unify your entire submission pipeline.
From EDC to eCTD.
Unified data pipeline
Connect EDC ingest, CDISC mapping, and TLG generation in one validated workflow
Continuous conformance QC
Catch errors at the source, before they compound across your submission cycle
Audit-ready eCTD assembly
Package and stage your eCTD with full traceability, ready for FDA and EMA transmission
Koneksa Platform Calendar
Koneksa Respiratory Data Insights
Koneksa Data Insights
Remote patient monitoring
Continuous, real-world data collected from patients in their everyday lives
Track real-time adherence
Platform dashboards monitor device wear, questionnaire completion, and participant compliance without code
Validated digital biomarkers
Package and stage your eCTD with full traceability, ready for FDA and EMA transmission
Not just endpoints. Impact.
We redefined how clinical evidence is generated.
Pioneers in digital biomarkers, we’re proving the value of our approach by applying it across programs, where measurement strategy, data capture, and interpretation must work together to generate reliable evidence.
30+
validated
measures
100+
implemented
assessments
50+
studies
supported
5+
therapeutic
areas
Who We Are
Your Clinical Data Innovation Partner
Koneksa Health accelerates drug development by powering evidence generation across clinical trials and real-world settings.
- We design and support studies end-to-end—integrating traditional biomarkers and generating digital biomarkers to uncover new signals in complex clinical data.
- Our proprietary platform enables remote, patient-centric data collection via wearables and mobile tech, delivering validated digital endpoints across multiple therapeutic areas.
- Backed by expert services in science, regulatory, and data analytics, we optimize trial design, streamline data pipelines, and develop models that drive smarter, faster clinical decisions.
What We Offer
Solutions That Move Medicine –
Faster, Smarter, Further
Clinical Trial Design & Execution
Design and execute remote-first, patient-centric trials that enhance retention, reduce burden, and unlock new and greater insights.
Digital Endpoints
Capture continuous, real-world data using validated measures built for regulatory confidence and scientific rigor.
Analog Endpoints
Integrate traditional clinical measures—such as lab tests, imaging, and functional assessments—into a unified data stream alongside digital biomarkers to create a holistic, multimodal evidence package.
Professional Services
Partner with our scientific, clinical, and regulatory experts to design, implement, and validate digital strategies across the drug development lifecycle.
Data Science, AI/ML, and Statistical Services
Unlock deeper insights from complex longitudinal datasets through advanced analytics, machine learning models, predictive algorithms, and rigorous statistical analysis – optimized for decision-making.
SaaS Platform Licensing
Deploy our flexible, sensor-agnostic platform to operationalize digital endpoints- with optional modules for data science consulting, custom algorithm integration, and regulatory reporting.
Access to and Generation of Multimodal Data Sets
We design and integrate 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.
Bring your
own model
License
Koneksa’s models
Co-develop
a model
The Koneksa Platform is designed to support flexible and regulatory-aligned evidence generation
Impact and Outcomes Enabled by Koneksa’s Multimodal Data Platform
Novel Algorithms to Predict Disease Progression
Advanced modeling enables earlier and more accurate insights into patient trajectories.
Patient-Enriched Trial Design
Smarter stratification and eligibility criteria increase relevance and impact.
Improved Signal Detection and Statistical Power
Frequent high-precision measures reduces noise and enhances results clarity.
Greater Study Participant Engagement
Seamless digital integration improves adherence and data completeness.
Faster, Smarter Trials
Efficient data pipelines accelerate trial timelines and decision-making.
Therapeutic Impact
Supported 50+ clinical programs across neurology, oncology, respiratory, and rare diseases.
Evidence Generation
Peer-reviewed publications, posters and intellectual property items.
Adoption by Industry Leaders
Trusted by leading biopharma, CROs, and academic research consortia.
Case Study
How Our Models Help Predict Parkinson’s Risk
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.
Our scaled compute allowed 10 – 20x faster delivery of extracted insights
Data
Sources
Extracted Physiological
Features
Integrated Machine
Learning Model
Development of
Risk Index
Risk is Associated
with Clinical Severity
See the Science in Action
MANUSCRIPT
Impacts On Study Design When Implementing Digital Measures In Parkinson’s Disease-Modifying Therapy Trials:
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MANUSCRIPT
A Proposed Multi-Domain, Digital Model For Capturing Functional Status And Health-Related Quality Of Life In Oncology:
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MANUSCRIPT
A Patient Centric Model For Vaso-Occlusive Crises In Sickle Cell Disease — Outcomes Of A Consensus Exercise Conducted Across Patients And Experts
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Learn More Select Clients and Partners
Press + Media
The Latest From Koneksa
Koneksa Launches the First Intelligent Submission Software to Unify the Clinical Submission Pipeline in a Single Auditable Workflow
Purpose-built for biometrics and regulatory operations, Lodestar™ eliminates submission pipeline fragmentation through AI-assisted, auditable workflow, validated in completed LEARNS clinical study. New York, NY — June 2, 2026 —…
Koneksa Achieves Key Milestone with Database Lock for KH007 Study Evaluating Parkinson’s Disease Progression
Completion of data collection enables full analysis, with topline results expected in June 2026 New York, NY — 23 April 2026 — Koneksa, a measurement-science partner for clinical development,…
Koneksa Recognized in Multiple Independent Digital Biomarkers Market Reports Amid Accelerating Industry Growth
Inclusion across leading analyses reflects growing adoption of digital biomarkers and growing need for more rigorous measurement strategies in clinical development New York, NY — March 17, 2026 —…
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