Digital Endpoints for Clinical Research
Too many trials fail because of the lack of sensitive endpoints. To address this challenge, we provide disease-specific validated endpoints.
Sysnav Healthcare delivers validated digital endpoints based on patients’ daily lives. Our endpoints measure real-world motor function and ambulation, powered by Syde’s centimeter-precise 3D movement reconstruction.
We support pharmas, CROs, and academic researchers with regulatory-qualified digital endpoints (SV95C) and comprehensive clinical trial operations services.
Quick 30-minute discovery call • Guaranteed response within 48 hours
Example of Use Cases
Types of studies:
Phase I Phase II Phase III Natural history studies
Therapeutic Areas:
Neuromuscular diseases Neurodegenerative Autoimmune neurological Neurodevelopmental Joint Skeletal dysplasias
Geographical Scope:
Worldwide deployment Solution available and operational worldwide
Sysnav Healthcare, an End-To-End Solution for Your Clinical Trial
Sysnav Healthcare provides clinical trial sponsors with the Syde platform, a validated digital endpoint solution for mobility-affecting diseases.
Our GCP-compliant operational support teams work alongside your CRO and site personnel to prepare full documentation for regulatory submission, ensure data quality through real-time monitoring, and deliver analysis-ready datasets. This allows your teams to focus on interpreting results rather than managing technology.
In real life, the Syde® sensors continuously record data during the day while the patient wears them.
At night, they are placed on their docking station for battery charging and data uploading.
Our Digital Endpoint Capabilities
- Real-world motor function assessment: Continuous measurement of upper and lower limb movement, and gait parameters in patients’ daily environments with centimetric precision (>97% stride detection accuracy)
- Regulatory-qualified digital endpoints: SV95C (Stride Velocity 95th Centile), the first EMA-qualified digital endpoint, plus validated endpoints for 20+ disease indications including MS, ALS, Parkinson’s, and rare neuromuscular disorders
End-to-End Service Package
- Turnkey technology deployment: Ready-to-use Syde sensor kit (wearables, docking station, batteries) with multi-language patient instructions, site training materials, and plug-and-play setup requiring no technical infrastructure
- Dedicated operational support: Assigned study manager providing protocol consultation, real-time compliance monitoring (>90% adherence across trials), and proactive site support throughout study duration
- Regulatory-ready data packages: Analysis-ready datasets with validated digital endpoints, complete analytical and clinical validation documentation for FDA/EMA filings
Evidence and Proof Points
Sysnav Healthcare is proud to be trusted by a global network of pharmaceutical companies and research institutes that demand excellence at every stage of the drug development lifecycle.
Geographic footprint of Syde as of January 2026
Published Evidence: Studies Using the Syde Technology
From Validation to Study-Ready Outputs
Sysnav Healthcare’s endpoint development process transforms raw sensor data into regulatory-grade clinical trial outcomes through a systematic validation framework. Each digital endpoint undergoes rigorous analytical validation and clinical validation before deployment in trials. This evidence-based approach ensures that sponsors receive defensible, interpretable endpoints.
Analytical and Clinical Validation
Our analytical validation demonstrates >97% stride detection recall, >99% precision, and centimetric accuracy for 3D trajectory reconstruction across diverse patient populations and disease severities.
With ongoing or finished natural history studies in 20+ indications, we conduct extensive disease-specific clinical validation, to establish clinical meaningfulness and sensitivity to change of our digital endpoints.
Operational Readiness & Regulatory Documentation Package
We provide GCP-compliant services covering device deployment, site training, data collection, quality control, and troubleshooting. This ensures that clinical teams can execute trials confidently without requiring DHT (Digital Health Technology) technical expertise.
Implementation Process
Sysnav Healthcare follows a structured implementation process designed to integrate seamlessly with your clinical trial timeline. Each study is assigned a dedicated Study Manager who serves as your single point of contact throughout the entire journey, ensuring continuity, accountability, and personalized support from initial setup through final data delivery. Our approach ensures regulatory compliance, data quality, and minimal burden on sites and patients. We align with your timelines to meet the deadline of your clinical trial.
Our teams have the capacity to support centralized, hybrid, and fully decentralized clinical trials.
TRIAL DESIGN AND PREPARATION
Sponsor’s Clinical Development
Sponsor’s Clinical Ops
- Scientific support on protocol design
- Regulatory support on submission
GCP-COMPLIANT TRIAL EXECUTION
Sponsor’s Clinical Ops
CRO
Site Clinical Staff
Patient
- Site training
- Device logistics
- Technical support
- Real-time, individual compliance monitoring
TRIAL DATA ANALYSIS AND EXPLOITATION
Site Clinical Staff
- Periodic data transfer
- Tailored analyses
- Quality control
- Support for data interpretation
We ensure that trials produce reliable, actionable, and regulatory-ready outcomes, that are meaningful for the patients.
Privacy and Security
Sysnav Healthcare upholds the highest standards of data protection, security, and regulatory compliance. Our Syde platform is designed with privacy-by-design principles and operates under certified quality and information security management systems to ensure patient data confidentiality and trial data integrity.
No location tracking
No microphone
ISO9001, ISO13485, and ISO27001 certified
No personal identifiable information (email, IP address, etc.)
Sysnav Healthcare upholds the highest standards of quality and security:
FAQ
Answers to common questions about integrating Syde platform into your clinical trial.
What is the typical deployment timeline from contract to first patient data collection?
Standard deployment takes 8 to 12 weeks and includes Syde specific protocol consultation, regulatory documentation preparation, site training, and device shipment. Accelerated timelines are available for urgent trials, and we align with your existing study startup milestones to minimize delays.
What data outputs do you provide?
We provide periodic data transfers containing validated clinical endpoints in a format compatible with your statistical software. Each delivery includes tailored analyses customized to your protocol requirements, comprehensive quality control reports with patient-level compliance and data completeness metrics, and dedicated support for data interpretation to help your teams understand the endpoint’s clinical significance.
What does your support model include during the trial?
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