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Safety management
Research & Development RA SA Safety Management Services provide a complete safety services, including processing of individual reports on adverse events from clinical trials and adverse drug reactions for marketed products, preparation of individual reports for expedited submission to health authorities and regulatory regulations.
Our Services and Capabilities
- Reporting of Serious Adverse Events (SAEs) in International Clinical Trials
- Processing and Reporting of Adverse Drug Reactions (ADRs)
- Writing Periodic Safety Update Reports (PSURs)
- Designing, Conducting, and Analyzing Safety and Pharmacoepidemiological Studies
- Generating Integrated Summaries of Safety (ISS)
- Consulting and System Analysis
Reporting of Serious Adverse Events
Research & Development RA SA has standardized, proven processes and systems for managing reports of serious adverse events (SAEs) in international clinical trials. Furthermore our ability to track your safety data in either your specific database or our own database means that your safety data will be processed consistently and accurately.
Written medical evaluations include narratives, causality assessments, follow-up information from the investigational sites and recommendations for reporting to regulatory authorities. We can submit SAE reports in an agreed format to you or directly to the appropriate authorities.
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