MacroStat---- Our services include clinical trial data management, statistical analysis, and clinical study report writing.
Our Data Management System
MacroStat has the data management system which meets the requirement of FDA CFR 21 Part 11 (Electronic Records and Signatures)
- Data-base Securities
Computers and database applications are password protected
Applications for users and database work independently
Accesses of system administrators and users strictly follow the SOPs
- Various Working Mode
Double data entry and electronic validation are performed
One data entry with 100% manual proof-reading is performed
- Audit Trail
Any login is automatically recorded and tracked
Change histories for data entry and modifications are recorded
Reasons must be provided before data modifications
- CRF Tracking, Lock and Unlock
- Regular Database Backup and Remote Backup
- Training on Data Management SOPs
- Automatic Output to SAS Datasets
- Multiple Options of Database (Oracle, MS Access, and MS SQL)
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