ePRO & eCOA

Extending the traditional PROs

Healthentia ePRO/eCOA extends the traditional PROs, by capturing data and measurements related to the patient reported experience and patient reported behavior that can even be used as endpoints in clinical trials. 

The ePRO/eCOA is in the form of a BYOD application running in both iOS and Android smartphones and capturing data from IoT devices (wearables, medical devices, other sensors), thus reducing significantly the heterogeneity of the patients’ responses making possible, to a higher extent, the understanding of the real differences in the perception of the outcome, as compared with the information collected via open-end questions.  

EPRO-ECOA

Capabilities

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Customizable widgets

Real-time monitor of your population's data from any device

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Multi-lingual

The participant of a trial can pick from the available languages of a study at registration and can cahnge it after from its profile.

 

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Smart chatbot support

A subject can interact through a protocol assigned script with an investigator or get technical support

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eConsent

Electronic informed consent (eConsent) is available in the Healthentia

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IoT connected devices

API or SDK integration with Internet of Medical Devices

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Teleconsultations / Televisits

 

 

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Customizable Widgets as ePRO features

  • Study widget 
  • Activity widget
  • Sleep widget
  • Vital signs widget  
  • Medication management 
  • Symptom tracking 
  • Nutrition widget  
  • Liquid widget

Participatory co-design

The advanced usability and UX of Healthentia ePRO/eCOA benefiting the patients, is a result of a co-design principle followed with patients and other stakeholders. Further to the usability aspects, Healthentia offers several features to the patients that contribute to higher degrees of engagements. 

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Certifications & compliances

Healthentia is used by Top5 Pharma and large hospitals and operates under the strict regulatory framework of Good Clinical Practice

  • GxP compliance 
  • ISO 27001 certification & GDPR compliance 
  • 21 CFR Part 11 / 21 CFR 820 compliance 
  • HIPAA compliance 
  • CDISC compatibility 
  • ISO13485 Certification  
  • Class I Medical Device (*) 

(*) ongoing Class IIa submission under MDR 

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Symptom Tracker

Symptom tracker is the simplest form of Healthentia, available to all citizens at no cost. It has been released in spring of 2020 as our ethical obligation to contribute to the pandemic needs and has been adopted by a major hospital in Europe. Today, patients and healthy individuals can download Healthentia Symptom Tracker in their smartphone and explore functionalities, such as:

  • Lifestyle tracking
  • eDiary of symptoms
  • Pairing of various sensing devices
  • Medication management

Quick Start Guides in EN, FR, NE and GE

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