Data Management

CTCC offers you, our client, complete services of GCP-compliant Data Management processes for clinical trials with either electronic or paper-based CRFs. Our Clinical Data Management Systems are validated according to regulatory requirements. We have implemented quality assurance and quality control processes to produce secure and valid data for statistical analysis.
Our services include:

  • Design and Review of CRF (electronic or paper)
  • Preparation of Data Management Manuals, Data Review Plans, Data Entry Guidelines
  • Study Database setup, validation and maintenance (including comprehensive plausibility checks)
  • User training comprising eLearning and help desk
  • Double data entry for paper-based studies
  • Data cleaning and query management
  • Study specific reports online or through scheduled mailing
  • Email alerts on events, e.g. “new patient” or “new SAE”
  • Coding
  • Management of lab data
  • SAE reconciliation
  • Database closure and data export
  • CDISC SDTM mapping

For more specific information please contact:

Ingrun Leyendecker, Team Lead

CTCC Data Management
Phone: +49 221 478 88132