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

BioSerenity is committed to contributing for clinical research to the Medical Research Community, the Pharmaceutical Industry, and Medical Devices Companies, in accordance with local ethics and regulations.

We offer expertise in clinical trials, from proof of concept to post marketing studies. through our medical devices and subsidiary, Serenity Medical Services, we offer both the execution and the remote analysis of several electrophysiological exams for in-patient or at home patients, as well as the patient monitoring.

BioSerenity is committed to enhance clinical research by simplifying patient recruitment, screening, diagnostics, follow-up, and long-term monitoring, as well as to support therapeutic testing, notably during the FDA and EMA approval processes.

  • 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
  • RECRUITMENT

    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
  • SAFETY DEMONSTRATION

    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
  • EFFICACY DEMONSTRATION

    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
  • PATIENT FOLLOW-UP

    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
  • DATA GENERATION

    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

The Cardioskin can be used during clinical trials

This medical device is FDA cleared and CE marked.

It consists of a 15 leads ECG for up to 14 weeks of recording in health care facilities or in the patient’s home.

The Cardioskin can be used by investigators during clinical trials for:

  • Patient screening and selection: identify the appropriate patient cardiac criteria for your clinical trial
  • Patient monitoring during the trial to detect potential cardiac changes and cardiology drug efficacy and safety
  • Patients long-term monitoring for drug effectiveness and safety

Available soon: the Neuronaute will be available for clinical trials use

It will allow remote EEG recording in health care facilities or in the patient’s home.

The Neuronaute can be used by investigators during clinical trials for:

  • Patient screening and selection: identify the best patient neurologic criteria for your clinical trial
  • Patient monitoring during the trial to detect potential neurological (EEG) changes and neurological (i.e.epilepsy) drug efficacy
  • Patients long-term monitoring for drug effectiveness and safety
  • The Cardioskin can be used during clinical trials

    This medical device is FDA cleared and CE marked.

    It consists of a 15 leads ECG for up to 14 weeks of recording in health care facilities or in the patient’s home.

    The Cardioskin can be used by investigators during clinical trials for:

    • Patient screening and selection: identify the appropriate patient cardiac criteria for your clinical trial
    • Patient monitoring during the trial to detect potential cardiac changes and cardiology drug efficacy and safety
    • Patients long-term monitoring for drug effectiveness and safety
  • Available soon: the Neuronaute will be available for clinical trials use

    It will allow remote EEG recording in health care facilities or in the patient’s home.

    The Neuronaute can be used by investigators during clinical trials for:

    • Patient screening and selection: identify the best patient neurologic criteria for your clinical trial
    • Patient monitoring during the trial to detect potential neurological (EEG) changes and neurological (i.e.epilepsy) drug efficacy
    • Patients long-term monitoring for drug effectiveness and safety

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