MainEDC ePRO

MainEDC™ ePRO is an electronic patient-reported outcome module developed by DM365, designed for use in decentralized and classical clinical trials across all phases, as well as feasibility studies, patient registries, pharmacovigilance, laboratory trials, and marketing data collection. It functions as a configurable platform for simultaneous collection of clinical, drug safety, and marketing data, and can operate either as part of the broader MainEDC™ platform or as a standalone solution.

The system supports subject self-registration with or without an access approval step, which is intended to expand the pool of potentially eligible subjects beyond traditional clinical site boundaries. It is available as both a mobile application and a web-adapted page, and supports white-labeling so that sponsors can publish the app under their own company name in the Apple Store and Google App Market.

Supported Use Cases

• Decentralized and classical clinical trials of all phases
• Electronic informed consent (e-Consent)
• Data collection from medical devices and wearable devices
• Pharmacovigilance source data capture
• Laboratory trials
• Patient registries
• Feasibility studies
• Marketing and drug safety data collection

Key Features and Capabilities

• Subject self-registration for clinical trials, feasibility studies, marketing programs, and patient registries
• Electronic sign-off of informed consent and personal data processing agreements
• Multi-factor authentication via SMS and email
• Quick and easy subject addition from the investigator interface
• Immediate access to collected data from investigator and site team interfaces
• Rebranding and white-labeling for mobile apps and desktop/mobile websites
• Support for up to 100,000 subjects within a single project
• Integration with wearable devices including fitness trackers and smart watches
• Automatic processing of up to 60 marketing indicators, including cell phone number, UID, IDFA, IP address, MAC address, operating system, and user location
• Built-in medical coding using WHODrug, MedDRA, ATC, and ICD
• Advanced API for external integrations
• All MainEDC™ Data Management and Data Science functionality, including export to all formats
• Export to CDISC SDTM, SAS, XML, XLS, and Module formats
• Compliance with 21 CFR Part 11, GAMP5, and HIPAA

Platform Tiers and Subject Limits

• Basic: fewer than 20 surveys, fewer than 150 subjects
• Pro: fewer than 50 surveys, fewer than 500 subjects
• Pro Plus: unlimited surveys, fewer than 1,000 subjects
• Enterprise: unlimited surveys, fewer than 2,500 subjects
• Enterprise Plus: unlimited surveys, fewer than 6,000 subjects
• VIP: unlimited surveys, 10,000 or more subjects

MainEDC™ ePRO shares its platform infrastructure with the EDC, IWRS, and Drug Supply components of the MainEDC™ suite, and supports the MainEDC™ Hi Load technology for larger studies. The platform has been validated through benchmark testing and practical use in clinical studies enrolling up to 70,000 subjects each. Pricing is structured per study per month across the available tiers.