# Live Study Management

## 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

### Regulatory compliance

- FDA 510k Class II (USA)
- HIPAA Compliant (USA)
- MHRA Class IIb (UK)
- CDSCO Class C (India)
- EU MDR Class IIb (EU)
- TGA Class IIb (Australia)
- Saudi FDA Class C (Saudi Arabia)
- MOHAP (UAE)
- MDSAP (Japan, Australia, Canada, US)
- NHS DSPT (UK)

##### International medical device standards

- IEC 62304
- IEC 62366
- IEC 82304-1
- ISO 14971
- ISO 14155

##### QMS & info security management

- ISO 13485
- ISO 27001
- 21CFR820 (QSR)
- SOC 2 Type II

##### Technical documentation

- Complete STED file
- Audits passed by Notified Bodies

## 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.

[**Increasing clinical trial success rates with adaptive technology**](/content/newsroom/adaptive-trials-technology/index.html)

[**Fixing the foundations: building a solid evidence base for digital health pp**](/content/newsroom/fixing-the-foundations-building-a-solid-evidence-base-for-digital-health/index.html)

## Take the next step

Tell us what you’re working on and what you need from Huma to move forward.

- Full name
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