MainEDC™ – Electronic Data Capture / Interactive Web Response System & Drug Supply Management / ePRO
Every Tier Includes
- Validation Pack (IQ, VSR)
- Audits and Inspections QA Support
- SaaS Private Cloud / Personal Virtual Server
(сlasterization in at least 2 DCs and 3xDay data backup)
- Emergency IT Support 24×7
- Drag&Drop Advanced Study Designer
(pre-build templates, images, links, coder etc.)
- Built-in eCRF Design Approval Tool
( + eCRF Annotated MS Word/PDF generation)
- Built-in CDISC CDASH Reference
- Trial and Visit Structure Tool
- Subject Scheduling Tool
- Hybrid Study Support
- Real-time Interactive Dashboards
- Query Management Tool
- Real-Time Edit Checks and Triggers
(+ library)
- 40 Built-in reports and Report Tool
- E-Mail Notification Builder
- Blinded / Unblinded Protocol Deviations Management
- Automated Medical Coding using AI
- Protocol / Amendments / ICF Versions Management
(LEC management / personal route for subject)
- Study Documents with Electronic Signature / News Tracking
- Central and Local Lab Support
- Multilanguage Study Support
- Data Management Clean and Check Tool
- User’s, Sites and Investigator Management Tool
- Import Tool
- Plain Export Tool (*Excel, CSV, PDF, Module)
- Unblinded Staff Area
- Subject Transfer Tool
- Electronic Signature Support
- Users’s Permissions Advanced Tool
- Audit Trail based on BlockChain technology
- Personal link yourcompany.mainedc.com /
yourcompany.investigator.site
- Unlimited Visits / Data Points
- Pre-configured Integration
(17 – Central Labs, CTMS, ePRO etc)
- LOINC Support
- Built-in Help Center
- ATC / ICD Browser
- SAS Ready Export
- Source Data Tracking for Remote Monitoring
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Transfer of competence (Data Management / Data Science)
The budget calculation is based on a clinical trial protocol/synopsis/assumptions.
Please send your protocol/synopsis/assumptions to contact@datamanagement365.com and get your budget proposal.
Go with DM 365 Technology Transfer and get the Tier down price
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