EDC / eSource / IWRS MODULE
Electronic Data Capture (EDC) / eCRF is a module to manage all clinical data management aspects including study planning, data base creation and validation, data capturing, queries management, data cleaning, medical coding, data export, etc.
Smooth EDC includes eSource (Source Documentation) functionality which reduces costs for CRF completion and source data verification.
IWRS (Interactive Web Response System) is used for clinical trials’ randomization and supplies management. IWRS is integrated with EDC.
The features of the module include:
- Prompt and easy eCRF building
- Dynamic forms and data entry checks
- Go-to-Green navigation technology
- Multilanguage interface – use of different languages in the same trial
- All types of randomization and dose regimens
- Variability of stratification methods
- Investigational Product supply management
- Medical Monitor review and approval
- Quick deployment and adjustments to protocol amendments
- GCP E6 R2, CDISC, GAМP 5, 21 CFR Part 11, GDPR, HIPAA compliant
- Easy access for investigators and other roles in the study (data manager, logistics manager, pharmacist, medical monitor, site data entry, CRA, read only)
- Easy navigation to quickly find, select, and move within studies, sites, subject and pages
- Access to the system from any device at any time