Pharmacovigilance

Our safety and pharmacovigilance department oversees the overall safety of subjects enrolled in a study, with a focus on compliance with FDA and ICH regulations. We specialize in managing clinical trial adverse events (AEs) and serious adverse events (SAEs), including initial AE/SAE receipt, case processing, follow-up, medical review and case closure. Our safety and pharmacovigilance experts are also responsible for medical monitoring and medical coding activities.

Our highly experienced clinical safety professionals provide clinical and medical expertise to evaluate the safety and conduct of Phase I-IV clinical trials. Their support safeguards the success of a clinical trial through delivery of high-quality clinical safety and pharmacovigilance services to our clients.

Our services include:

• 24/7 serious adverse event (SAE) reporting and medical coverage
• Global drug and device-related safety reporting activities
• Safety management processes and procedures
• Safety management planning and development
• Safety reporting activity management
• Submissions of expedited and non-expedited safety reports to regulatory authorities
• Drug safety update reports (DSURs) and periodic safety reports
• Reconciliation of safety database with clinical database
• Coding of adverse events and concomitant medications
• Medical review of all clinical trial-related documents
• Preparation of narratives, MedWatch and CIOMS reports
• Review of subject eligibility
• Physician review of adverse events, labs, vital signs, ECGs and other subject safety data
• Site support to answer product and protocol questions
• Annual reports
• Study design consulting