Pharmacovigilance

SGS Medical Affairs provides comprehensive and flexible solutions for the active management of drug safety and risk management during the complete life cycle of a medicinal product. The multi-disciplinary team offers:

• Therapeutic expertise, technical and operational excellence
• Tailor-made and cost effective drug safety solutions to small and mid-size pharmaceutical companies
• Flexible outsourcing of drug safety functions to large international organizations
• Quality system ensuring continuous compliance to international regulatory requirements
• Training, consultancy and education

In early phase clinical research, SGS Medical Affairs drug safety experts deliver a fast and tailor-made solution to meet clients’ safety needs.

Medical Affairs Services include:

• Set-up and maintenance of a safety database
• Serious adverse event management
• Expedited reporting
• Annual Safety Report writing
• Eudravigilance registration consultancy

Late phase clinical research service offerings include serious adverse event management throughout the complete development process, expedited (electronic) regulatory reporting, set up and maintenance of a global safety database, MedDRA coding, complete Medical Monitoring/consultancy, report writing. Post-marketing services ensure continuous monitoring of quality, safety and efficacy of the marketed product. Reporting adverse drug reactions to the authorities is a service that SGS Medical Affairs offers, thus, proactively avoiding costly setbacks that can threaten both product revenues and reputation.

• 24/7 availability
• In-house serious adverse event management/expedited reporting
• Medical monitoring
• Report writing (annual/periodic reports, expert reports, safety summary, IB/CCDS updates)
• Safety analysis and risk management