e-Clinical Solutions for IND Stage Trials
Pulls the study team together for consistent and credible
results
Based on the EDCPRO platform, SCiAN's
Custom Software Development team delivers integrated e-clinical
solutions matching your needs and streamlining key trial management
activities across many tasks, departments and expertise in your
clinical trials:
- Full EDC functionality
- Randomization - all randomization algorithms and blinding
methods supported
- Study drug and clinical supply management (IWRS)
- SAE management with SAEPRO or integration with your
internal system
- Coding - SAE reconciliation modules
- Central data monitoring tools
- Document management
- Central lab, ECG, Imaging data integation with your internal
and 3rd-party systems
- DSMBs, Interim and final analyses management module
- CTMS modules:
-
- Regulatory documents management
- Protocol Amendments - EC/IRB approval tracking
- Contacts management
- Resource allocation optimization
- Dashboard of key performance indicators: key trends,
comparisons, and exceptions
- Site payments module.
Core functionality
- FDA 21 CFR Part 11 compliant
- Intuitive user interface - guided data input & on-line help
system
- User qualification module
- User registration and access management
- email notification system
- Comprehensive document management module
- On-demand reporting / data export
- Data import using CDISC ODM compliant transfers from 3rd
parties
- Data export / archiving using CDISC ODM compliant XML
format
- PDF archiving.