We provide complete data management services from Protocol Design to Database Lock, aiming at delivering the services in compliance with the regulatory requirements, Standard Operating Procedures, and client specific requirements if any.
Our systems are 21 CFR Part 11 compliant and our team is equally competent to meet the client’s expectations.
- CRF design and preparation
- Database Design and setup
- AE/SAE Reconciliation
- Electronic Data Capture
- Data Entry/ Date integrity check
- Medical coding using MedDRA and WHO DD Dictionaries
- Database Cleaning
- Database lock and transferring the data to SAS output
- Data Validation & Query Management
- EDC Consulting