Product Overview
MainEDC™ was created without any third-party acquisitions or integrations. The system is compliant with the FDA requirements (21 CFR Part 11) as well as with GCP, GAMP 5, HIPAA, and GDPR. The system is validated and all of our clients are provided with private cloud hosting – no multi-tenant use. The data is stored in qualified data centers and we provide a full audit trail based on blockchain technology.
MainEDC™ ensures quick start-up and close-out thereby saving your precious time during the study and you can make sure that if there are any mid-study updates or amendments made to a protocol that these changes will be promptly adjusted.
You can access the system from any device at any time and get the full picture of what is going on thanks to a series of comprehensive dashboards and notifications.
Deployment
- Web based
- Cloud Hosted
Pricing
- Subscription
- License Fee
More Information
- Drag&Drop Advanced Study Designer
- Built-in eCRF Design Approval Tool
- Central and Local Laboratory data handling
- Automated medical coding based on AI and SEC functionality
- Risk Based Monitoring Tool (incl. SDV control)
- All types of randomization and dose regimens
- Drug supply, inventory management, kit replacement, emergency codebreak, unblinded staff area
- Effective analytical tools for Sponsor oversight of the clinical data
About the company
Data Management 365 is a software firm with deep expertise in clinical trials. We emphasize robust skills in Clinical Data Management and Data Science, enabling us to address Data Managers’ challenges, enhance our MainEDC™ platform through real-time feedback, and share best practices with clients. This expertise also aids communication with Clinical Data Management professionals. We originated as a spin-off from Flex Databases and were founded by IT experts, doctors, and researchers experienced in clinical trials. Thus, we intimately understand and cater to Data Management Software needs using cutting-edge tech.