Study Start-up
eCRF Design
User Acceptance Testing
Data Validation Plan
- Online (Real Time, Batch): Integrated with EDC
- Offline (SAS)
EDC User Training
Data Management Plan
External Data Integration
- Data Transfer Specification
- Central Lab
- ECG Core Lab
- Pharmacokinetic/Pharmacodynamic Data
- IxRS Data
- CTMS Data
- ePRO
- Devices
Study Conduct
Data Review/Cleaning
- Data Tables, Listings and Figures
Patient Profile
DSMB Support
External Data Reconciliation
SAE Reconciliations
Medical Coding
Data Standard
- CDISC SDTM Mapping Annotation (aCRF)
- CDISC SDTM Mapping Programming
- CDISC SDTM Define.xml
- CDISC SDTM Reviewer’s Guide
- Sponsor Specific Standards
Study Closeout
Database Lock
- Multiple DB Lock Support
- - Adaptive Study Designs
- - Interim Analyses
- - Final Lock
- Clean File Meeting
- - Data Lock Documentation
Regulatory Submission Support