Pharmacovigilance

It's peace of mind -- and more. Global Safety AdvantageSM is an enhanced and seamless Global Safety Surveillance and Pharmacovigilance program.

Robust Service Offering. Using the Oracle™ Adverse Event Reporting System (AERS), Global Safety Advantage provides clinical and post-marketing adverse event (AE) and serious adverse event (SAE) reporting from initial data collection to regulatory submission and beyond to post-marketing coverage. We also offer several other value-added, innovative programs to meet your needs.

• Non-serious and serious adverse event case processing
  • Data entry, MedDRA and WHO-DD coding
  • SAE narrative writing
  • Physician medical review
  • Generation of MedWatch 3500A/CIOMS I forms
• Preparation of periodic safety update reports (PSURs) and periodic adverse drug experience reports (PADERs), as well as EU Annual Safety Report (EASR) and Pre- and Post-clinical Risk Management Plans (EU RMPs)
• Management of treatment Investigational New Drug (IND) and Compassionate Use programs
• Pharmacovigilance plan for marketing application
  • Risk Minimization Action Plan (RiskMAP)
  • Risk Evaluation and Mitigation Strategy (REMS)
  • Risk Management Plans
• Epidemiologic Analysis
• Signal detection of safety data
• Scientific literature review for adverse events
• Safety data reconciliation
• Establishment of database systems and Standard Operating Procedures (SOPs)
• Consultation and assessment of safety systems and processes
• Temporary staffing with experienced safety professionals

Superior Safety Professionals. Our multidisciplinary and multilingual team of global Medical Doctors, PharmDs, Registered Nurses and healthcare professionals are well versed on each project’s objectives and protocols, as well as all drugs and devices involved with the study.

Round-the-Clock Availability. An adverse event can happen anytime, anywhere. That’s why we have health professionals in over 30 countries around the world and in five time zones prepared to receive your reports. We offer dedicated phone and fax lines enabling you to personally contact a dedicated Safety Officer in your region and time zone.