Data Management
At ICRC-WEYER we have developed our own SAS-based Data Management- and Data Cleaning Systems which conform to CDISC (ODM, SDTM Standards). The adaption to CDASH is nearing completion. Our in-house EDC-system for post-marketing studies is currently in the validation process.
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 to medicine. All Data Management personnel are experienced in a range of study phases, and are specifically trained for each individual study.
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
- Database Design
- eCRF setup
- Creation of Data Management Plans and Edit Check Specifications
- Data Entry
- Medical Coding
- 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)
- HARTS (AE coding)
- Query system (SAS-based, handling of automated and manual queries)