Pharmacovigilance & Patient Safety
Effective assessment of risk and benefits to guarantee the focus on patient safety
Pharmacovigilance is one of the main areas for safety assurance and patient outcomes generation. This is a main point of focus as product and patients’ safety is directly linked with product market offer and value.
As patient safety always comes first, Eurotrials’s Pharmacovigilance consultants can support you during the entire lifecycle of your product, having a deep insight into 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 pharmacovigilance consultants are committed to delivering 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. On the other hand, with a worldwide presence, CTI also offers an interactive approach to global safety and pharmacovigilance.
Our services cover medicinal products, medical devices, and cosmetics.
- AEs/ADRs management
- SAEs processing and reporting
- DSUR writing, reviewing and submission
- Benefit-risk assessment and management
- Incidents reporting
- Implementation of applicable corrective actions
- Periodic reporting
- Responsible Person
- Undesirable effects collection, assessment and reporting
- Product Safety Reports
- 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