DCT & HYBRID CLINICAL TRIALS

Huma powers digital-first research accelerating therapies for patients

Our award-winning technology supports decentralized and hybrid clinical trials that get effective treatments to patients faster. Our DCT platform can improve trial participation, diversity, engagement and efficiency, at scale.

Transforming research

1.8M

Active users acrossour platforms1

100+

Highly configurable self-service platform with library of modules and capacity to connect to 100s of devices1

Prix GalienInternational 2022Award Winner2

Selected to power some of the world's largest DCTs including five countries and languages across two continents

Huma’s DCT platform capabilities

Powering some of the world’s largest DCTs, Huma enables better research by remotely collecting real-world data.

Recruitment

Our platform supports multiple participant recruitment strategies, including social media and marketing

eCOA/ePRO

Use questionnaires, videos and images to facilitate robust collection of research-grade clinical data via app or web

Eligibility screening and onboarding

Access broader populations and identify suitable participants with remote screening, and onboard them using ID verification

Connected devices

Enabling capture of vital and non-vital signs through connected medical devices, sensors and wearables - with over 1m devices included to date

eConsent

Seamlessly obtain informed consent with engaging and educational content that can build trust and support retention³

Telemedicine

Provide tele-visit and tele-consent, messaging and clinical support through secure video and audio consultations, to make logistics and communication easier³

Carers and proxies

Increase inclusivity by allowing participants to add carers and proxies who can respond to study activities on their behalf

Educational content

Engage and inform participants with educational content about the research study, how it will operate, ongoing support and relevant contact details

Recruitment
eCOA/ePRO
Eligibility screening and onboarding
Connected devices
eConsent
Telemedicine
Carers and proxies
Educational content
Site performance analytics

Manage multiple sites within a web-based portal, with data on target enrolment numbers, recruitment performance and study protocol compliance

Participant-level monitoring

Allows real-time visualisation of participant data, with built-in flagging systems to detect non-compliance or clinical events, to intervene as necessary

Permission layers

Smart analytics dashboards with deep and configurable permission layers for easy access to data for all relevant stakeholders

Telemedicine

Sponsors and CROs can securely communicate with participants through messages, video and audio calls. Remote visits can be scheduled or participants can be contacted immediately³

EDC interoperability and data exporting

Participant-generated data can be exported at any time from Huma's systems, in multiple file formats. The data can then be consumed onwards and refresh EDC systems and registries

Call-centre support

Participants who do not have access to a smartphone can ring a call-centre, whose staff can use the web portal to answer questionnaires on their behalf

Site performance analytics
Participant-level monitoring
Permission layers
Telemedicine
EDC interoperability and data exporting
Call-centre support
Site performance analytics

Manage multiple sites within a web-based portal, with data on target enrolment numbers, recruitment performance and study protocol compliance

Participant-level monitoring

Allows real-time visualisation of participant data, with built-in flagging systems to detect non-compliance or clinical events, to intervene as necessary

Permission layers

Smart analytics dashboards with deep and configurable permission layers for easy access to data for all relevant stakeholders

Telemedicine

Sponsors and CROs can securely communicate with participants through messages, video and audio calls. Remote visits can be scheduled or participants can be contacted immediately³

EDC interoperability and data exporting

Participant-generated data can be exported at any time from Huma's systems, in multiple file formats. The data can then be consumed onwards and refresh EDC systems and registries

Call-centre support

Participants who do not have access to a smartphone can ring a call-centre, whose staff can use the web portal to answer questionnaires on their behalf

Site performance analytics
Participant-level monitoring
Permission layers
Telemedicine
EDC interoperability and data exporting
Call-centre support

Benefits of the platform

How our DCT platform can help accelerate timelines and reduce costs

Faster decision-making with real-time analytics

Customise dashboards to provide real-time insights regarding site and participant performance, help proactively and safely monitor participants and improve protocol adherence

Keep participants engaged and
improve retention

Intuitive UI design, educational content and notifications to optimise participation and engagement, whilst seamless device connection and tele-visits reduce patient burden

Research-grade data collection

Collect robust, high-quality health data from sensors, devices and questionnaires with our comprehensive platform

Connect and combine

Flexible connection with Electronic Data Capture and other datasets / registries, as well as near real- time access to Electronic Health Records, pharmacy and claims records to build a richer patient profile4

Why Huma?

3,000+ hospitals, clinics and 1.8 million active users supported across Huma platforms1

Huma wins 'pharma's Nobel prize’ 2022 Prix Galien USA for it’s digital health platform3

Modular, flexible design and technology platform to enable rapid configuration of study protocols

Highly-prized user- experience delivering high protocol compliance and retention rates5

Industry-leading and flexible IoMT integration with privileged access to raw wearable data from connected devices

We are certified under ISO 27001, Cyber Essentials Plus and we are 21 CFR and GxP compliant

Cloud-agnostic platform that can be deployed globally in any language across multiple therapeutic areas

Who we work with

Huma has deployments with top 10 pharmaceutical companies, national governments, major healthcare providers and leading research institutions around the world and was selected to power one of the largest global decentralised clinical trials for AstraZeneca

Our experience in delivering better research

phase iv trial
atrial fibrillation
covid-19
diabetes

Supporting AstraZeneca with an international Phase IV study

AstraZeneca selected our DCT platform to support one of the world’s largest decentralized clinical trials. Designed to use remote recruitment, ID verification, and safety data collection through our secure platform, the first patient was recruited less than three months after the project was signed. In order to ensure access for all populations, participants have multiple means to engage and are able to submit data on either an app, web portal or through a call centre.

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30K

Participants for target enrollment

5

Different countries and languages

2

Continents

Powering a DCT in atrial fibrillation with Bayer and Stanford Medicine

Huma, Bayer, Stanford Medicine and the Stanford Center for Digital Health together demonstrated the feasibility, for the first time, of a scalable, fully decentralized cardiovascular intervention trial requiring remote physiologic measurements among participants with atrial fibrillation. The trial had a robust recruitment strategy and strong engagement. Participants successfully transmitted physiologic BP and ECG measurements, tracked OAC adherence, completed regular surveys and televisits using Huma’s DCT platform. The findings provide a strong foundation to inform the design and conduct of future decentralized protocols for cardiovascular trials.

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2 weeks

94% of participants recruited in 12 days6

96
%

Increased oral anticoagulation adherence from 85% to 96% in patients with low baseline6

86
%

Participant retention6

Pioneering a decentralized clinical study with the University of Cambridge

Huma partnered with the University of Cambridge (Medical Research Council Epidemiology Unit) to understand the progression of COVID-19 infection and build predictive models for pre-symptomatic infection. The study uses Huma’s digital platform to remotely collect data from nearly 2,500 participants from the Fenland cohort. This builds on 15 years worth of retrospective data to generate new insights and a joint analytics dataset for digital biomarker discovery.

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1.6 million

Data points collected over 10 months7

Largest

Population-based app study of its kind7

640,533

Person days of data +3,500 historical metrics per participant7

Interventional Trial For High-Risk Type 2 Diabetes Patients

The study is a collaboration between Huma, Astra Zeneca and Imperial Health Partners. With the initial promising results from the interventional trial that included 600 participants, the aim is to scale the programme nationally, to create a real-world dataset to support high-quality research and transform care pathways for patients with type 2 diabetes, reducing complications and improving outcomes.

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70
%

of participants improved their diets/average weight loss of 4.1kg8

82
%

Protocol compliance rate8

17
mmol/mol

average reduction in HbA1c8

Regulatory, safety and compliance

ISO certifications

ISO 13485: 2016 certified (Medical Devices: Quality Management Systems)

ISO 27001: 2013 certified

Medical device registrations

CE marked class I Medical Device

Registered with the MHRA as a Medical Device

US FDA Class I exempt and enforcement discretion

Data protection /infosec

Committed to GDPR compliance

NHS Registration on Data Security and Protection Toolkit

CyberEssentials /
CyberEssentials Plus

US FDA 21 CFR compliances

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