CTCC offers you, our client, complete services of GCP-compliant Data Management processes for clinical trials with electronic CRFs.

Our Clinical Data Management System is validated according to regulatory requirements. We have implemented quality assurance and quality control processes to produce secure and valid data for statistical analysis.

• eCRF Design
• Preparation of Data Management Manuals, Data Review Plans, Data Entry Guidelines, Reconciliation Manuals etc.
• Study Database setup, validation and maintenance (including comprehensive plausibility checks)
• User training comprising eLearning and help desk
• 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 (MedDRA, WHO-DDE)
• Management of lab data
• SAE reconciliation
• Database closure and data export
• CDISC SDTM mapping