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.
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.
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.
Physiotherapy & ActiMyo:
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.