MARVIN – Features

Seamless integration of EDC (electronic data capture), CDM (clinical data management) und CTM (clinical trial management) functionality and working processes in a single, central, (online) CDISC ODM database:

• Multi-language data acquisition including a full audit trail
• Concomitant medication documentation (extendable list of drugs)
• Data cleaning and query workflow (automatic validation rules, cross-page, cross-visit)
• Electronic signatures and source data verification
• Clickable maps for data entry on anatomic images
• Source data verification
• News and documentation page
• Text messaging (SMS)
• Randomization
• Drug accountability and logistics (stock and shipment management)
• User, role and center management; non-investigator data entry (administrative forms workflow)
• Online reports
• Metadata version management  (mid-study protocol amendments)
• Easy and fast automatic set-up of the complete system (database, query logic and web-based data entry screens) based on a study protocol in CDISC ODM format without programming.
• Professional architecture based on JAVA and XML, 100% online, running on almost any browser
• Fully validated according to GCP and 21 CFR 11, confirmed by several external audits

CDISC - clinical data interchange standards consortium

ODM - operational data model

EDC - electronic data capture/collection

CDM - clinical data management

CTM - clinical trial management