MainEDC Platform

MainEDC Platform is an electronic data capture (EDC) and interactive web response system (IWRS) developed by DM365 for use in clinical trials and research studies. The platform covers the full data lifecycle — from eCRF design and data entry through to randomization, drug supply management, and patient engagement — and is aimed at sponsors, data managers, investigators, pharmacists, and patients.

The system is built without third-party acquisitions or integrations and is validated for compliance with FDA 21 CFR Part 11, GCP E6 R2, GAMP 5, HIPAA, and GDPR. Each client receives private cloud hosting with no multi-tenant use, data stored in qualified data centers, and a full audit trail based on blockchain technology.

Core EDC Capabilities

• Drag-and-drop advanced study designer for building eCRFs
• 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, including source data verification (SDV) control
• Support for all types of randomization and dose regimens
• Drug supply management covering inventory management, kit replacement, emergency code break, and an unblinded staff area
• Analytical tools for sponsor oversight of clinical data
• Comprehensive dashboards and notifications for real-time study oversight
• Quick start-up and close-out, with prompt implementation of mid-study protocol amendments
• Access from any device at any time

IWRS Features

• Fully integrated with the EDC module, but can also operate as an independent application
• Strictly controlled randomization and drug dispensing conditions
• Randomization and drug dispensing managed from a single interface, with no external links required
• Strict role separation between blinded investigators and partially or fully unblinded pharmacists
• Flexible and customizable randomization and drug dispensing mechanisms
• Automated drug supply management to reduce human factor risk

Additional Modules

• ePRO: Supports decentralized research, patient engagement, registries, and marketing activities
• eConsent: Electronic consent collection included within the platform ecosystem
• PACS: Medical imaging data management as part of the broader solution set
• AI Tools: Built-in artificial intelligence tools for process acceleration and decision-making

Training Options

• Deep-dive onsite training for data managers: three full days, eight hours per day
• Face-to-face training for investigators: up to four hours
• Web training available as either extended sessions or one-time consultations
• Self-training supported through educational materials provided by DM365

MainEDC Platform is delivered as a SaaS solution with premium-level cloud hosting, private cloud backup, and helpdesk support included. Pricing starts from $399 per month. The platform is accessible to teams, physicians, researchers, and patients from any device, and contact for inquiries or demo requests is available through DM365 at [email protected].