Clinical Data Management

CDSA has robust processes and data capture systems that ensure reliable data quality and an audit trail. The clinical data management system at CDSA is installed in a secure and validated IT environment and provides the following customized data management services on the platform:

  • Development of data management plan
  • e-CRF designing
  • Data validation plan
  • Edit checks programming
  • Database development and maintenance
  • Coding of AE (MedDRA)
  • Coding of Concomitant medication (WHO-DD)
  • SAE data reconciliation
  • Audit trail
  • Data import set-up for third party vendor (Central Lab, ECG etc.)
  • Design and program data listings (for sponsor review)
  • Create and provide patient profiles (for sponsor review)
  • Customized reports
  • Database lock (final analysis)
  • Data backup
  • Data export
  • Electronic signatures functionality

 

We have provided data management support to academic institutions, government and non-governmental innovators and SMEs.