Covid-19

Huma’s virtual clinical trial solution

In response to COVID-19, Huma has configured a decentralised trial solution focused on remote data capture. This includes e-consent, ePRO collection, biometric capture, wearables, and telemedicine/virtual visits. This out-of-the-box solution can be deployed in 15 days and is easily integrable into other systems.

Functionality

How the solution works

Participant App: Remote participant data capture with in-built e-consent and telemedicine created on an infrastructure allowing for tailoring of assessments to study protocol. Integrates wearables and houses educational content for improved participant engagement.

Site Dashboard: Web-based analytics dashboard accessible by research teams to visualise participant data generated from the Huma app in real-time. Includes communication with participants directly via telemedicine, monitoring of deterioration and adverse events with automatic flagging system based on configurable thresholds.

of deterioration and adverse events with automatic flagging system based on configurable thresholds.

Integrated devices: We have integrated a portfolio of over 400 external wearables and connected devices to enable seamless data capture, whilst establishing partnerships with device manufactures to deliver deployment at scale.

How it works

How does our app support
participants?

e-Consent

In-built e-consent functionality allowing participants to be fully informed prior to trial initiation and support remote on-boarding.

Telemedicine/
Virtual Study Visits

Ability for the participant to receive virtual clinical visits for continued remote engagement & secure communication within the app.

Medication tracker
and adherence

Medication list with dosage/frequency, remote titration through the portal and adherence assessment with insight into factors for non-compliance.

Participant Engagement

Dissemination of clinical trial content to maximise engagement and reduce dropout rate (e.g. current advice, trial details, mental health, etc).

Participant
Eligibility/Stratification

A single, points-based measure of overall health captured using only a smartphone. Clinically validated with data from half a million people over 10+ years. Developed with KOLs from Johns Hopkins, Harvard, Imperial College London and more.

ePRO/Symptoms
and Side Effects

Create bespoke questionnaire or digitise validated ePRO measures

Biometric Tracking

In-app data through utilisation of built-in phone sensors (eg camera PPG for HR, HRV, rhythm assessment) and/or 3rd party device integration for active and passive biometric collection.

  • e-Consent
  • Participant Eligibility/Stratification
  • Telemedicine/Virtual Study Visits
  • ePRO/Symptoms and Side Effects
  • Medication tracker and adherence
  • Biometric Tracking
  • Participant Engagement

In-built e-consent functionality allowing participants to be fully informed prior to trial initiation and support remote on-boarding.

A single, points-based measure of overall health captured using only a smartphone. Clinically validated with data from half a million people over 10+ years. Developed with KOLs from Johns Hopkins, Harvard, Imperial College London and more.

Ability for the participant to receive virtual clinical visits for continued remote engagement & secure communication within the app.

Create bespoke questionnaires or digitise validated ePROM measures.

Medication list with dosage/frequency, remote titration through the portal and adherence assessment with insight into factors for non-compliance.

In-app data through utilisation of built-in phone sensors (eg camera PPG for HR, HRV, rhythm assessment) and/or 3rd party device integration for active and passive biometric collection.

Dissemination of clinical trial content to maximise engagement and reduce dropout rate (e.g. current advice, trial details, mental health, etc).

Database

Site Dashboard

Our web-based data dashboard provides a comprehensive overview of data points that include: individual participant data and progress, functionality for tele-medicine visits, symptom and side effect tracking, rules-based prioritisation, and researcher data entry.

All data is securely hosted on AWS cloud and can be exported to meet study database requirements.

Compatible with

Pathways

Demonstration of decentralised
trial pathway

Participant pathway

Remote on-boarding through SMS or e-mail link. In-app screening questionnaire to establish eligibility and data baseline.

Research team pathway

List of all on-boarded patients with prioritisation of those that are eligible.

Participant pathway

Remote collection of e-consent in app. Study information and instructions provided during consent process.

Research team pathway

Consent record logged in database.

Participant pathway

Participant follows set of pre-determined activities for active and passive data collection. App dashboard allows individual patient insight (but can also be blinded)

Research team pathway

Site dashboard logs in real-time all participant data input including data extraction from Apple Health and Google Fit. Individual patient records allow for trend visualisation and comparison of multiple data points.

Participant pathway

In-app notifications provide reminders of activities to complete/data to enter. Activity schedules are created in accordance with the study protocol.

Research team pathway

Participants are visually prioritised according to pre-determined metrics (e.g. engagement, deterioration, side effects).

Participant pathway

In-app virtual telemedicine visits allow for secure and easy remote communication with research team.

Research team pathway

In-portal virtual telemedicine visits allow for secure and easy remote communication with participants.

Case study: Digital Biomaker

Co-developing ReVeRe
with Janssen (J&J)

RAVLT 2.0

In partnership with Johnson & Johnson, we are commercialising and further validating a digital biomarker focussed on early detection of Alzheimer's disease through assessing verbal episodic memory via voice recognition technology. The biomarker enables entire populations to be screened for early cognitive decline, enhancing strategic health population management.

J&J have chosen Huma as their partner due to our experience in digital health development, the APAC market, and biomarker validation engine. Using our reach and globalisation platform, the digital biomarker will be further validated for use in Mandarin, and subsequently commercialised globally.

CASE STUDY
Our experience in COVID-19

Live projects in the UK (NHS) and Germany

Patients are able to remain at home under the supervision of their care team using our remote patient monitoring solution. This supports hospital capacity as well as reducing unnecessary travel and exposure to others.

Care teams are able to configure thresholds for alerts and use the flagging system to identify COVID-19 patients’ health deterioration or improvement, adjusting care plans accordingly.

Healthcare teams
better allocate
time & resources
Full focus on
rescuing
severe cases
Isolate and monitor
patients remotely
Patients feel
reassured
Learn from every case,
every data point

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Download our COVID-19 Return to Work Research Report here.

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