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. From preclinical studies to post-marketing settings, we are uniquely positioned to provide comprehensive pharmacovigilance services to help you address product safety concerns with confidence.

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 deliver safety data of the highest quality. Working globally, i3 can provide integrated and standalone services to support product safety monitoring in compliance with regulatory requirements for safety surveillance in pre- and post-approval 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
  • Global multi-lingual call center services for marketed products
  • Management of standard and non-standard/off-label medical inquiries from consumers and health care providers
  • Option to utilize lower-cost case processing services at our location in India

Expert collaboration

i3 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.

REMS

Within inVentiv Health, we have a specialized center of excellence for REMS design, ParagonRx, which protects trial stakeholders in several ways:

  • Protection of clients from REMS-related brand failures
  • Protection of patients from avoidable medication risks
  • Protection of brands from unnecessary restrictions to market access and commercial success
  • Protection of healthcare providers from infeasible intrusions into care delivery

As an i3 client, you'll have access to ParagonRx's thorough understanding of REMS element requirements and extensive experience with program elements throughout the lifecycle of a REMS program, from strategy through implementation to continuous improvement.

Learn more about our REMS center.