Engage a team of global safety experts for safety reporting and post-marketing surveillance

Specializing in safety services for the pharmaceutical industry since 1980, Covance Periapproval Services supports you with dedicated, multilingual and multidisciplinary teams that provide comprehensive safety and pharmacovigilence programs to ensure patient protection.

Built on a foundation of extensive experience and expertise:

• Teams have backgrounds and training in safety, clinical research, data management, and regulatory affairs
• Reporting experience from more than 100 NDA, OTC and monograph products 

Standardized platforms across all regions:

• Common standard operating procedures (SOPs) and a single technology platform (ARGUS Safety Web) for all safety centers
• Regulatory reporting for expedited adverse events (AEs) in North and South America, Western and Eastern Europe, South Africa and Asia-Pacific region.

 Services:

• SAE reporting for phase II, III, IIIb and IV clinical trials
• Safety call intake centers (receipt of initial calls, initiation of electronic or paper reports/notifications)
• Medical review of triaged reports
  • Literature searches
• Safety data extraction from legal documents
• Data entry into safety databases
  • Data quality checks
• Medical and consumer follow up
• Preparation of regulatory and health ministry safety reports