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Solutions & Services

MainEDC™ trusted by hundreds of Data Managers and Data Science specialists

Integrated, configurable, and reliable solution for impressive data capture results

Private cloud hosting (SaaS)
GCP E6 R2, GAМP 5, 21 CFR Part 11,
GDPR, HIPAA compliant
Quick deployment and adjustments to protocol
amendments
Prompt and easy eCRF building,
MainEDC™ Plus for Patient Access (ePRO)
Easy access for investigators via www.yourcompany.investigator.site

Electronic Data Capture

Reliable:

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.

Functional:

  • 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 

Convenient:

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.

IWRS

  • Fully integrated with EDC
  • Can work as an independent application
  • Strictly controlled randomization and drug dispensing conditions
  • Randomize and arrange drug dispensing just from the same interface, no external links required
  • Strict role separation – blinded Investigator and partially unblinded/fully unblinded Pharmacist

Benefit from MainEDC™ IWRS:

  • Make use of flexible, easily customizable, and fully controlled mechanism of randomization and drug dispensing
  • Enjoy all types of randomization and dose regimens
  • Automate the drug supply management – mitigate the human factor risk significantly

Take Full Advantage of MainEDC™

  • Save time and resources on every step that you take in the system: eCRF building, data entry, data export
  • Feel confident about your data security
  • Save time on adjustments — enjoy easy and quick implementation of protocol amendments
  • Get full control of your clinical study in real time – enjoy special built-in reports and analytical tools to make decisions quickly
  • Enjoy the fixed price for the private cloud, backup, and helpdesk support
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Training

Get your team trained for MainEDC™!

Types of training:

  • Deep-dive onsite training for Data Managers, 3 full days, 8 hours per day

  • Comprehensive face-to-face training for Investigators, up to 4 hours

  • Web training – it can be either an extended training or a one-time consultation, we are always ready to support you with the system knowledge and share some useful tips

  • Self-training – we provide educational materials to support your self-tuition

Undergo a deep-dive training on the system and enjoy extended 3-month support.

Get the best price for your clinical trial

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Starting from $399
Get your MainEDC™ with private cloud, backup, and helpdesk support starting from just $399 per month
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Have you got any questions?
Please email us at
contact@datamanagement365.com