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The importance of timely collection, analysis and accurate reporting of drug safety data from clinical studies and marketed products are a regulatory requirement and a vital strategic need.
Our experts in the dedicated Kendle safety and pharmacovigilance group are comprised of specialists with a total of over 150 years industry experience in human safety. Our Regulatory Affairs group knows the latest and ongoing developments in drug safety monitoring and reporting and can bring your department up to speed or help you develop your own policies and procedures to ensure full compliance with global safety reporting requirements.
Kendle's pharmacovigilance and safety services
- Global adverse event management for clinical trials and in-market products
- Pharmacovigilance training
- Assessment and evaluation of reportability and submission of reportable events to FDA, EMEA or other appropriate regulatory authorities
- Online coding (MedDRA, WHO-ART) of adverse event information
- Preparation and submission of global safety reports (internal or MedWatch/CIOMS for regulatory submission)
- Preparation of Alert letters (Dear Doctor)
- Medical monitoring
- Custom safety reports including trend analysis
- Post-marketing surveillance reports and PSURs
- Drug Safety Monitoring Board functions
- Skilled use in your or our adverse event processing systems (e.g., Argus, ArisG, ClinTrace)
- e2B electronic submission capabilities
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