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
Liaison with Health Authorities
Our services on clinical investigation research consultancy include:
- Development of Safety Data Management Plans
- Review of Protocols
- Development of Safety Data Exchange Agreements
- Development and submission of Safety Reports (DSUR & SUSARs)
- Pharmacovigilance Standard Operating Procedures
- Complete manage of Serious Adverse Reactions (SAEs)
- Set up of Pharmacovigilance Systems
- Training to investigators and CRAs
What is Vigilazierta?
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.
Vigilazierta complies with all safety regulations. Vigilazierta controls the submission deadlines. Vigilazierta integrates E2B Gateway. Vigilazierta provides data security. Vigilazierta is intuitive and agile. Vigilazierta is profitable.