DCT & HYBRID CLINICAL TRIALS

SAMD for Pharma

SAMD for Pharma

Minimise time lost to mid-study changes with the ultimate in adaptive trial platforms

Mid-study changes are inevitable. Unlike hard-coded platforms, Huma’s highly adaptable platform is designed with flexibility in mind to enable real-time modifications and additions to study protocols without having to go back to the drawing board.

Quicker changes with real-time configurability

Unlike other platforms, Huma is designed to be highly flexible to changing requirements, providing unparalleled configurability.This means that required, approved trial changes can be made immediately, with minimal time needed for User Acceptance Testing due to our intuitive UX design.

Self-serve or account managed change orders

We’ve designed our platform to be easy and intuitive to modify protocol changes and trial variations. Make your own changes directly in our configurable platform or use Huma’s expert team to make the changes for you.

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

Keep participants informed about the latest protocol changes

One challenge of trial changes is keeping participants in the loop. With Huma, you can easily choose which participants and participant cohorts will be able to see updates to protocols and testing regimes. As well as publishing updated trial guidance in the “Learn” module.

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