Designing new endpoints
to accelerate medical progress for mobility assessment

Developing treatments for neuromuscular and neurological disorders raises a challenge: collecting enough relevant data to provide reliable clinical outcome assessments while setting up a representative study cohort with enough volunteers.

Traditional clinical trials based on statistics and controlled environments can fail to provide variables representative of the efficacy of treatments because they may not accurately represent patients’ real capabilities due to short term variabilities (fatigue, motivation, context…).

Based on real-world data and continuous measurement, the Syde platform is able to create precise, meaningful, and representative endpoints that can be collected from fewer patients.

Digital endpoints the future of clinical trials

While traditional clinical tests were created decades or even centuries ago, modern technology can provide more representative clinical outcome assessments of a therapy with continuous real-life data.

With leading institutions, patient associations, and healthcare professionals, Sysnav Healthcare has developed a proven capability to co-design digital endpoints that meet the requirements of clinical trials (objectivity, reliability, sensitivity to change, and clinical meaningfulness). 

Thanks to Syde, SYSNAV Healthcare has become a recognized provider of real-world evidence for pivotal clinical trials.



SV95C: the only digital endpoint qualified by the EMA

In 2023, the Duchenne Muscular Dystrophy (DMD) Community achieved a significant milestone as the European Medicines Agency (EMA) officially validated SV95C (Stride Velocity 95th Centile) as a primary endpoint for superiority studies. This validation offers a valuable alternative to the 6 Minute Walking Test for evaluating ambulant DMD patients.

SV95C is the first regulatory-qualified real-world digital outcome measure for use as a primary endpoint in pivotal studies of Duchenne Muscular Dystrophy. It represents the top 5% fastest strides a patient spontaneously takes in their normal daily environment over a pre-defined time period. SV95C can be applied in therapeutic, confirmatory and natural history studies.“>Read our EMA qualification

This recognition opens up new horizons, paving the way for the widespread adoption of digital endpoints as the primary evaluation criteria in clinical trials today and daily clinical care tomorrow.

Scientific Publications

Towards personalized medicine

Post-approval applications

Sysnav healthcare invests in R&D and technologies that produce, manage and analyze real-world data to drive major transformations in healthcare with individualized medical solutions that are more efficient and cost-effective.

Personalizing a treatment response for each patient is ultimately leading to a shift in the clinical treatment paradigm from a trial-and-error process to “the right drug, for the right patient, at the right time” approach.

With the Syde platform, SYSNAV Healthcare is offering stakeholders access to the data needed to adapt healthcare protocols and economic models and to put evidence of improved patient outcomes at the center of treatment. In the future, SYSNAV Healthcare will be extending Syde’s use in clinical trials, fueling phase 4 with precise and aggregated data.