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