# Digital Study Deployment

## Quickly and efficiently create a study for a specific therapeutic area

[Get started](/content/solutions/life-sciences-clinical-research/digital-study-deployment#form/index.html)

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.

Our highly configurable platform - combined with deep domain expertise - enables you to deploy a robust clinical trial that’s specific to your therapeutic area. Continuous device data collection ensures higher accuracy.

## Powerful, modular SDK (Software Development Kit) that can adapt to your exact TA protocol

With a platform that can be, without hard coding, reconfigured in minutes, we help ensure your study’s protocol integrity. Our out-of-the box option, is a pre-configured setup for major therapeutic areas which delivers faster TA study deployment.

## Build a therapeutic set-up for your precise TA needs

Huma’s easy-to-configure end to end solution, without hard coding, allows a faster setup for your specific study requirements. Our platform can also be customised for specific projects where integration with an EDC is required.

Huma’s platform features pre-built modules including eConsent, ePRO and eCOA that can be configured and adapted to your specific protocol, enabling quick setup of your therapeutic study requirements. This includes our unique approach to questionnaire branching which can save valuable time in setup and study changes.

## 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

## Integrated support and expert team

Huma’s experienced team is on-hand to ensure your therapeutic trial is set up to your exact requirements. Our fully-regulated platform can be deployed across multiple countries and offers reliability and a high degree of user acceptance at scale.

## Take the next step

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