ICH-GCP compliant data management is standard for us: We advise you from the beginning and take over the development of electronic Case Report Forms (eCRF) including the implementation of plausibility checks, consistency checks, reports and data cleaning with qualified query management.

In addition, the preparation of data for statistical analysis and general support for database users are parts of our team’s tasks.

The CTC Cologne is certified as an ECRIN data centre since the end of 2020.

ECRIN (European Clinical Research Infrastructure Network) links national academic research infrastructures - networks or individual institutions - in Europe and provides sponsors and investigators with access to information, advice and services for the implementation of multinational clinical research projects. Over 50 academic clinical research partner organisations provide high quality services under the ECRIN umbrella.

As part of the ECRIN certification programme, the CTC Cologne was audited in an on-site audit with regard to compliance with the published ECRIN data standards in the areas of data management, IT and quality management.

The successful certification was granted for 4 years.

The certificate of the ECRIN Data Centre Certification Programme can be found here.

Our data management services at CTC Cologne include:

• CRF development (CDASH compliant)
• Creation of data management manuals, data review plans, data entry guidelines, reconciliation manuals, etc.
• Development of the study database (incl. plausibility checks), validation and maintenance
• User training incl. eLearning and help desk
• Data cleaning and query management
• Study-specific reports online or via secure data transfer
• Email alerts for events such as "new patient" or "new SAE" message
• Medical coding (MedDRA, WHO Drug Dictionary)
• Laboratory data management
• SAE reconciliation
• Reconciliation of external clinical data
• Database lock and data export
• CDISC SDTM mapping