Effective assessment of risks and benefits
As patient safety always comes first, Eurotrials Pharmacovigilance team can support you during the entire lifecycle of your product, having a deep insight on the benefit-risk profile of the product.
We provide high quality, efficient and reliable services not only during clinical development, but also during post-marketing surveillance. Our highly experienced local teams are committed to deliver the best solutions complying with the latest local and international regulations.
With offices in Europe and Latin America, we can monitor safety and risk management throughout the product lifecycle, giving you an integrated and competitive advantage with a top class consulting service.
Our services cover medicinal products, medical devices and cosmetics.
From Clinical Development to Post-Marketing:
Safety is a crucial part of the clinical program:
- AEs/ADRs management
- SAEs processing and reporting
- DSUR writing, reviewing and submission
- Benefit-risk assessment and management
Safety continues to be a concern once product gets on the market:
- Qualified Person for Pharmacovigilance / Back-up
- ICSR collection, processing and reporting
- EudraVigilance registration and reporting
- Global/ Local literature surveillance
- Benefit-risk assessment
- PSUR writing, reviewing and reporting
- RMP writing and reviewing
- Development and implementation of educational materials
- Development and implementation of pharmacovigilance systems
- SOP writing and reviewing
- PSMF writing and reviewing
- Pharmacovigilance-targeted audits
- Preparation for regulatory inspections
- Incidents reporting
- Implementation of applicable corrective actions
- Periodic reporting
- Responsible Person
- Undesirable effects collection, assessment and reporting
- Product Safety Reports
- Undesirable effects collection and reporting
Prepare yourself and your teams for Pharmacovigilance compliance!
- Pharmacovigilance training courses.