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Pharmacovigilance of clinical trials |
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- Comprehensive Management of Adverse Reactions
- Database Design for the management of Adverse Reactions
- Data Encryption
- Preparation of Security Annual Reports and DSURs (updated to the current law)
- Preparation of Standard Operating Procedures in Clinical Trials Pharmacovigilance
- Design of Data Collection Notebook and Research Archive
- Processing of permits with AEM, CEICs, CCAA
- Monitoring
- Consultancy
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