Pharmacovigilance services
Infociencia provides services of Pharmacovigilance Externalization for Small-Medium Companies in Spain.
- We write Periodical Safety Reports and Expert Reports of commercialized drugs
- We manage all the adverse reactions of your drugs.
- We provide training about Pharmacovigilance procedures in Spain.
- Design of the Pharmacovigilance System and of Standard Operation Procedures
- MedDRA Services: Codification of databases and training courses
- All reports to Health Authorities
Safety Surveillance in clinical trials
Our clinical research team is available on 24/7 response line to take medically related questions or for reporting adverse events. Safety surveillance and reporting services include:
- Review of Protocol, Investigator Brochure, Informed Consent Form, and Case Report Form
- Safety monitoring
- Serious Adverse Event collection, evaluation, classification and reporting to Central IRB/ Sponsor/ Regulatory authorities
- Unblinding during Serious Adverse Event
- Developing safety database
- Periodic safety update reports
- Organize IDMB (Independent Data and Safety Monitoring Board)
To learn more about this service, please contact us at masinformacion@infociencia.com