Data Management Methodology - Data Management Services & Procedure

The following is a summary of our data management services and procedures:

Data Management Plan

  •  Project-specific data management standards and SOPs

Database Design

  •  Database definition
  •  Database security
  •  Data entry screens

Data Validation Plan

  •  Initial programming and query wording
  •  Testing and locking data validation plan
  •  Periodic re-testing

Data Entry (paper)

  •  Ongoing data entry from CRF – single or double entry
  •  Data entry cleaning

Medical/Science Review

  •  Review of marginal notes on CRF and Data Alerts
  •  Evaluating medical and scientific consistency of data

Data Validation and Query Management

  •  Periodic validation of CRF data
  •  Flexible query routing
  •  Accommodation 3rd party queries
  •  Query and resolution management over the internet

Database Lock and Audit

Database Documentation and Release

  •  Database transfer in Sponsor defined formats