Data Management
CIDP Biostats & Data is specialized in providing high quality service related to the management and analysis of data generated during clinical trials. Our data-related solutions cover a wide range of activities required for Clinical Data Management namely:
- Write up of Data Management Plan (DMP)
- Database Design and Test
- Data Validation Plan
- Data Handling and Entry Guidelines
- Data Entry (Single or double entry)
- Medical Review
- SAE Reconciliation
- Medical Coding (MedDRA and WHO DD)
- Data Validation and Query Management
- Database Lock and Audit
- Database Documentation and Release
Our tools
A Data Management solution fully compliant with FDA 21 Part 11 (On Oracle Database)
It is a comprehensive data management, monitoring and online clinical trial application suite, covering every stage of clinical trials thanks to its different modules:
- CSDesigner: Electronic CRF creation;
- CSEntry
- eCRF (CS Online)
- CSTest
- CSExport
- CSMonitor