The goal of BioSerenity is to increase the knowledge of targeted diseases through data analysis, companion diagnostics, and personalized medicine.

Simplify patient recruitment and targeting

• Patients’ recruitment through BioSerenity healthcare services in several therapeutic areas such as sleep diseases, neurology, and cardiology
• Creation and usage of patient cohorts for different therapeutic areas through our sleep centers
• Patients’ screening for inclusion into the most suitable clinical trials based on our medical devices, such as the Cardioskin and the Neuronaute

• 
  Phase 1 – Safety

  Adverse events detection
• 
  Phase 2 – Efficacy

  Adverse events and side effect detection, dose related efficacy
• 
  Phase 3 – Effectiveness

  Patient screening and adverse events monitoring, large sample clinical efficacy
• 
  Phase 4 – Continuous studies for long-term effectiveness and safety

  Comparative effectiveness and real-world evidence

Enhance the sensitivity of the detection of physiological changes

• Monitor patients with wearable medical devices for a continuous monitoring of patients, even outside consultations and during follow-up period up to several months
• Detect physiological changes through measurement of multifactorial electrophysiologic signals during clinical trials and follow-up
• Improve detection and notification of potential side effect and other physiologic events through event markers incorporated in our devices and the associated applications ePRO (electronic Patient Reported Outcome)

• 
  Phase 1 – Safety

  Adverse events detection
• 
  Phase 2 – Efficacy

  Adverse events and side effect detection, dose related efficacy
• 
  Phase 3 – Effectiveness

  Patient screening and adverse events monitoring, large sample clinical efficacy
• 
  Phase 4 – Continuous studies for long-term effectiveness and safety

  Comparative effectiveness and real-world evidence

Generate evidence of drug efficacy

• Limit standard deviations linked to cross-reviewers bias during analysis thanks to a centralized monitoring platform
• Limit standard deviations linked to cross-technologists bias during analysis thanks to worn medical devices allowing reproductible measurement
• Monitor patients with our medical devices during clinical trials in hospitals or remotely in ambulatory settings
• Monitor efficacy and continued safety of cardiac or neurological drugs
• Demonstrate drug efficacy and effectiveness by algorithms created by analyzing the collected data and allowing new biomarkers detection

• Phase 1 – Safety

  Adverse events detection
• 
  Phase 2 – Efficacy

  Adverse events and side effect detection, dose related efficacy
• 
  Phase 3 – Effectiveness

  Patient screening and adverse events monitoring, large sample clinical efficacy
• 
  Phase 4 – Continuous studies for long-term effectiveness and safety

  Comparative effectiveness and real-world evidence

Improve evidence generation and enrich real-world data

• Monitor patients with our medical devices operable in patients’ homes between consultations
• Track and display the data recorded based on our store and forward cloud-based systems, available for 15 years
• Develop real world data with our bench-to-bedside tools for continuous data flow
• Support translational medicine and better appreciate the patient’s journey through their disease monitoring

• 
  Phase 1 – Safety

  Adverse events detection
• 
  Phase 2 – Efficacy

  Adverse events and side effect detection, dose related efficacy
• 
  Phase 3 – Effectiveness

  Patient screening and adverse events monitoring, large sample clinical efficacy
• 
  Phase 4 – Continuous studies for long-term effectiveness and safety

  Comparative effectiveness and real-world evidence

Build a platform for Artificial Intelligence

• Gather the recorded data during clinical trials in a unique cloud-based platform
• Create artificial intelligence algorithms with a double objective:
  • during the trial improve the diagnostics and the monitoring;
  • and after the trial, propose the best care pathway for patients
• Support scientific knowledge, facilitate identification of diseases and sequelae, and enhance physiopathology mechanisms comprehension

• 
  Phase 1 – Safety

  Adverse events detection
• 
  Phase 2 – Efficacy

  Adverse events and side effect detection, dose related efficacy
• 
  Phase 3 – Effectiveness

  Patient screening and adverse events monitoring, large sample clinical efficacy
• 
  Phase 4 – Continuous studies for long-term effectiveness and safety

  Comparative effectiveness and real-world evidence