While traditional clinical tests were created decades or even centuries ago, modern technology can provide more representative clinical outcome assessments of a therapy with real-life continuous monitoring.
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 2019, the European Medicines Agency qualified the SV95C endpoint for use in pivotal and exploratory drug therapeutics studies for ambulant Duchenne Muscular Dystrophy (DMD) patients.
SV95C, or stride velocity 95th percentile, a measure of the top walking speed of patients at home, was selected as the most relevant measure to use in these studies.
As a consequence of its qualification by the EMA, SV95C can now be relied upon to measure a specific concept recognized for investigational new drug applications (IND).
This qualification paves the way for the broader adoption of digital endpoints as the main evaluation criteria for future clinical trials.
Sysnav Healthcare provides an all-in-one solution to assess the efficacy of a treatment complying with regulatory requirements. Syde is a complete and easy-to-use digital endpoint platform equipped with dedicated services and teams to efficiently deploy the technology, whatever the patient geographic situation and even if the HCP teams are not tech-savvy.
We provide a ready-to-use report, including real-world data and a set of variables according to the study needs.
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. SYSNAV Healthcare is also willing to extend Syde’s use in clinical trials, fueling phase 4 with precise and aggregated data.