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.

 

An all-too-common rarity

More than 7,000

rare diseases

Less than 5 in 10,000

people suffer from a given rare disease

350 million

patients suffer from rare diseases

75%

of patients are children

Way too rare solutions

3,200

genes identified as responsible for rare diseases

95%

of rare diseases have no curative treatment

50%

of patients have no accurate diagnosis

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 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.

 

sv95c

SV95C: the first digital endpoint qualified by the EMA

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. 

 

A trusted partner for your clinical operations

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. 

  • Definition of the variables according to the protocol of your clinical test 
  • Secured shipment and logistics 
  • Help center and training for caregivers, physicians, and medical teams to use Syde
  • Compliance monitoring and support to clinical centers 
  • Data management and analysis
  • Insights and recommendations for your clinical trial success

 

We provide a ready-to-use report, including real-world data and a set of variables according to the study needs.

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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. SYSNAV Healthcare is also willing to extend Syde’s use in clinical trials, fueling phase 4 with precise and aggregated data.