Data Management
At ICRC-Weyer, we have developed our own SAS-based Clinical Data Management System, which is compatible to CDISC standards .
All our systems can easily be adapted to the requirements of the study, and we are prepared to work with project-specific EDC and DM systems. We can offer electronic and paper-based as well as hybrid data capture and management.
Our Data Management team brings together professionals with backgrounds from mathematics, informatics, and medicine. All Data Management personnel are experienced in a wide range of study phases and indications.
Full integration of Data Management with our Biostatistics, Medical Review and Medical Writing departments and close cooperation with external partners allow us to offer our clients full service for phase I to IV and post-marketing studies.
Data Management Services:
- Consulting and Implementation of Data Management Strategies
- Case Report Form (CRF) Design and Printing, and/or eCRF setup
- CRF Annotations and Database Specifications
- Database Design
- Creation of Data Management Plans and Edit Check Specifications
- Data Entry
- Medical Coding
- PK Reconciliation
- SAE Reconciliation
- Electronic Data Transfer
- Data Validation and Query Management
Data Management Tools:
- EDC (web-based data capture for Phase I, II, III, IV, and post-marketing studies)
- System for capture of hardcopy data (SAS-based, paper or fax-transmitted)
- MedDRA (AE coding)
- WHO ATC (medication coding)
- Query system (SAS-based, handling of automated and manual queries)
