Safety and Pharmacovigilance

Safety and pharmacovigilance risk management has gained increased importance in global drug development due to a number of recent high profile drug withdrawals and growing expectations from consumers regarding product safety. While Medpace is focused on rapid approval of your compound, we also recognize the importance of identifying and assessing risk during clinical trials. To meet increasingly complex and diverse global regulatory requirements, Medpace has developed a comprehensive suite of services designed to ensure safety and expedite approvals. This process is monitored by licensed physicians who are trained to provide appropriate oversight and to analyze the full picture.

Services provided by Medpace Safety and Pharmacovigilance include:

• Collection, evaluation, analysis, and reporting of safety information, including serious adverse events and other significant safety events.
• Narrative writing.
• Global adverse event management for clinical trials.
• Assessment and evaluation of reportability and submission of reportable events to the FDA, European Medicines Agency (EMEA), or other appropriate regulatory authorities.
• Online coding (MedDRA, WHO Drug) of adverse event information.
• Preparation and submission of global safety reports (internal or MedWatch/CIOMS for regulatory submission), including electronic submission to EMEA EudraVigilance.
• Preparation of Alert letters (Dear Doctor).
• Custom safety reports including trend analysis.
• Post-marketing surveillance reports and Periodic Safety Update Reports (PSURs).
• Medical Monitoring Plan for clinical trials.
• ClinTrak Safety Management (SM) system.
• ARISg Global Safety Event Reporting System.

Want to learn more? Browse our capabilities, or contact the location nearest you.