CDISC
ICRC-Weyer works compliant to CDISC standards in Data Management and Biostatistics. With the development of our study specific Data Management solutions, compliance with the different CDISC standards is made simple and reliable. Setup of a study including SDTM submission can be achieved within a short period of time.
Define.xml
- Preparation of the CDISC Case Report Tabulation Data Definition Specification (define.xml, define.pdf), CRF annotation and hyperlinking CDASH
- Implementing CDASH for data collection is a fruitful fundament for all following steps
- ICRC-Weyer developed template CRF’s based on CDASH to ensure a high quality standard
SDTM/CDASH
- Mapping specification based on study protocol and CRF according to latest CDISC SDTM version
- Mapping of source data into FDA compliant CDISC SDTM standard
ADaM
- Definition and creation of study specific analysis datasets based on study protocol and SAP according to CDISC ADaM and ADaM IG (latest version)
- Creation of results metadata according to sponsor decision, contribution to define.xml/define.pdf and to reviewers guide
