Safety management in clinical trials is of crucial importance. Depending on the individual study setup, we provide the following safety related services: - SAE handling within 48 hours
- provision of electronic case reports (E2B - XML files)
- provision of completed CIOMS forms
- provision of case narratives
- distribution of case reports to national or central authorities adjusted to local requirements
- near time coding (MedDRA, ATC) of all safety related information
- interim analysis of adverse events
- establishment of independent data and safety monitoring boards
Our robust and validated safety management infrastructure can also be used for the management of post marketing authorization safety information (spontaneus adverse event reports).
Service includes: - double data entry of received AE reports
- coding of all safety related information (reactions, concomitant medications, medical history, treatments) against desired dictionaries (MedDRA, ATC)
- provision of electronic case reports (E2B - XML files)
- provision of completed CIOMS forms
- provision of case narratives
- trend, frequence and other analysis of adverse events per product or compound
- provision of line listings for PSUR integration
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