Eligibility Verification-Confirmation process
Medical consultations (e.g. eligibility criteria, protocol design, requirements and restrictions)
Review and analysis of safety listings and tables
Safety signal detection and analysis
Medical coding
Periodic Safety Reporting (DSUR and periodic line listings)
SAE/AE/ADR handling (collection, database entry and evaluation)
Identification of AEs of special interest and appropriate handling
Provision of CIOMS and/or MedWatch forms for all SAE reports within expected timelines
Registration with EudraVigilance
Overdose handling (collection, database entry and evaluation)
Pregnancy handling (collection, database entry and evaluation)
24/7 safety surveillance - available to Investigators for all PV related questions
Peri-marketing PV services
Case processing
Medical Coding
Narration writing
Case assessments and Case review
Periodic Safety Update report writing
