DCT & HYBRID CLINICAL TRIALS

SAMD for Pharma

SAMD for Pharma

Build. Personalise. Optimise.

Our platform is not hard coded, which makes it easier to create a study for your specific therapeutic area quickly and efficiently, and collect high-quality data specific to your TA protocol.

Combined with our deep domain expertise, our easy-to-build platform enables you to deploy a robust clinical trial at speed and scale for your particular therapeutic area. Achieve higher accuracy with continuous data collection and near real-time reporting.

Powering digital-first clinical research

eConsent

eCOA/ePRO

Telemedecine

Connected devices

FREE WHITEPAPER

The Evidence for Decentralized Clinical Trials

Since their creation in the 1940s, Randomised Controlled Trials (RCTs) have been the go-to method for treatment evaluations.
However, the traditional approach to these trials can slow down the research process. The DeTAP study, conducted by the Stanford School of Medicine in partnership with Bayer and Huma, showcased the immense potential of decentralized clinical trials (DCTs).
By adopting a digital-first approach, the study achieved high engagement, rapid recruitment, and increased medication adherence in patients with low baseline.
Read our whitepaper below to uncover the results of one of the first peer-reviewed assessments of a fully decentralized clinical trial:

Ready. Set. Go.

Streamlined user journeys help accelerate time to “first patient in” and get your trial up and running with minimal fuss. Our fully integrated screening and consent workflows enable quicker, easier setup and enrollment.

With less time spent on logistics, you’re free to focus on what’s truly at the heart of your clinical study: your participants.

Engaging. Efficient. Clinically proven.

Huma’s award-winning human-centered design has been developed with an understanding of the complex needs of patients and clinicians in mind, enabling us to impact each touchpoint across clinical trial phases. Now you can enroll participants faster and keep them engaged longer for better clinical trial outcomes.

Agile. Quick. Adaptable.

Mid-study changes are inevitable, but Huma makes things simple when they happen. Unlike hard-coded platforms, our highly adaptable platform is designed with flexibility in mind to enable near real-time modifications and additions to study protocols without having to go back to the drawing board.

Driving clinical research into the digital era.

As part of the Huma family, Alcedis’ unique approach combines full service clinical trial expertise with disruptive technologies creating significant advantages for patients, physicians and the life science sector. With over 25 years of experience, Alcedis pioneered data-driven studies from phase I through drug approval and beyond market access into real world evidence – aiming to create better outcomes for patients and to accelerate progress in human health.

Enhancing clinical research with AI.

Deeply rooted in clinical research, Alcedis Labs forms an integral component of the Alcedis IT department. Our primary mission involves tackling real-world challenges and designing AI software products that are instrumental in day-to-day clinical research activities. Through our extensive collaboration with various Alcedis departments, we consistently bring tangible value to our customers, prioritising their needs above all else.

Regulatory, safety and compliance

EU MDR 2017/745
Class IIb certified

MHRA registered Medical Device Class IIb

21CFR820 US FDA Class II

US Food and Drug Administration Medical Device 510k # K230214

ISO certifications

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


ISO 27001: 2022 certified

Data protection / infosec

Committed to GDPR compliance


NHS Registration on Data Security and Protection Toolkit


CyberEssentials / CyberEssentials Plus

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