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