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

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EU MDR 2017/745 Class IIb certified

MHRA registered Medical Device Class IIb

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US FDA 21 CFR compliances Class I exempt and under enforcement discretion

Part 11

Part 50

Part 820 ff

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ISO certifications

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

ISO 27001: 2013 certified

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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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