Azierta is a Scientific consultancy company with offices in Madrid, Barcelona and Bogotá. Through our network of partnership, we can provide scientific support worldwide.
We offer comprehensive services that range from early development, throughout the registration, until marketing and post-commercialization phases of your product.
Azierta provide a variety of services to ensure subjects’ safety throughout clinical trials in order to fulfill regulatory requirements and responsibilities.
- Clinical trials safety
- Management of daily PhV
- Safety Reports
- Liaison with Health Authorities
What are our services?
- Pharmacovigilance Standard Operating Procedures
- Complete manage of Serious Adverse Reactions (SAEs)
- Set up of Pharmacovigilance Systems
- Training to investigators and CRAs
- Development of Safety Data Management Plans
- Review of Protocols
- Development of Safety Data Exchange Agreements
- Development and submission of Safety Reports (DSUR & SUSARs)
Your IT Solution for Pharmacovigilance in clinical trials which provides best-in-class case management for a modern pharmacovigilance system. This database provides a single-global database capability for global safety case reporting.
- Data security.
- Intuitive and agile.
- Compliance with all safety regulations.
- Control submission deadlines.