LIGAND OFFERS PHARMACOVIGILANCE SERVICES FOR THE FOLLOWING.
DURING OF CLINICAL TRIALS:
Receiving/Processing/Archiving adverse events in countries of operation.
- Medical monitoring
- Ethics committee /IRB & MOH submissions
- Ensure compliance with local & International requirements
SPONSOR ASSISTANCE AFTER DRUG AUTHORIZATION:
- SOP Development
- MedDRA Coding
- Creation and maintains of database
- Electronic Reporting (E2B)
- Development Safety Update Report (DSUR) Preparation and Submission
- Global Literature Search & Review in Support of the DSUR
- Communication with authorities
COMPLIANCE WITH LOCAL REQUIREMENTS.