Comprehensive pre- and post-marketing pharmacovigilance services

In today’s biopharmaceutical product landscape, you can’t afford to miss crucial safety information about your products. We can help.

Knowledge and expertise

Our pharmacovigilance team is comprised of health care professionals with deep experience in both direct patient care and industry-specific pharmacovigilance services, which enables us to provide the highest quality safety surveillance services in pre-approval and post-marketing settings. Our services include:

• Collection, review, and follow-up of SAE and ADR reports
• Generation of regulatory reports
• Submission of expedited reports to regulatory authorities/competent authorities
• Scientific literature review for adverse events
• Call center services

Specialized tools

The comprehensive surveillance services of our pharmacovigilance team include:

• Our global safety database to track, process, and report adverse events
• Signal detection and evaluation services and technologies, including our unique, proactive safety surveillance tool, i3 Aperio^® 

In every case we work closely with epidemiologists to review the data to identify new trends or signals or to follow up on theoretical or actual safety concerns that have been previously identified.

i3 Drug Safety is uniquely positioned to provide comprehensive pharmacovigilance services.

Expert collaboration

i3 Drug Safety will bring expertise and dedicated, proven tools to support your pharmacovigilance program. Working closely with your teams, our safety experts will help organize, coordinate, and facilitate your surveillance activities on any scope you desire.