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 EPRO-ECOA](https://healthentia.com/wp-content/uploads/2021/12/EPRO-ECOA.png)
Capabilities
![icon11 icon11](https://healthentia.com/wp-content/uploads/2022/01/icon11.png)
Customizable widgets
Real-time monitor of your population's data from any device
![Frame 13 Frame 13](https://healthentia.com/wp-content/uploads/2022/01/Frame-13.png)
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.
![Group 228 Group 228](https://healthentia.com/wp-content/uploads/2021/12/Group-228-1.png)
Smart chatbot support
A subject can interact through a protocol assigned script with an investigator or get technical support
![Frame 15 Frame 15](https://healthentia.com/wp-content/uploads/2022/01/Frame-15.png)
eConsent
Electronic informed consent (eConsent) is available in the Healthentia
![Frame 12 Frame 12](https://healthentia.com/wp-content/uploads/2022/01/Frame-12.png)
IoT connected devices
API or SDK integration with Internet of Medical Devices
![Frame 14 Frame 14](https://healthentia.com/wp-content/uploads/2022/01/Frame-14.png)
Teleconsultations / Televisits
![MedicalDevice MedicalDevice](https://healthentia.com/wp-content/uploads/2021/12/MedicalDevice.png)
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.
![participatory design participatory design](https://healthentia.com/wp-content/uploads/2022/01/participatory-design-1.png)
![technical technical](https://healthentia.com/wp-content/uploads/2022/01/technical.png)
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
![ce_mark_v3 ce_mark_v3](https://healthentia.com/wp-content/uploads/2022/01/ce_mark_v3.png)
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
![Phone_website Phone_website](https://healthentia.com/wp-content/uploads/2020/05/Phone_website.png)