​Regulatory and Safety

Innovative approaches to stay ahead of regulatory change.

How can you succeed as demand increases for real world evidence to prove your product's safety and effectiveness? IQVIA is here to help.

Expand your options with real world

Increasingly, regulatory authorities are seeing the value of real world evidence (RWE) to evaluate a product’s safety and effectiveness. This changing environment presents you with new opportunities to increase the effectiveness and efficiency of your safety and regulatory studies.

At IQVIA, our global scientific and operational experts are developing innovative approaches for RWE study design and execution. Leverage secondary and primary data directly from patients and physicians to plan the most efficient study design for your needs. Applications include

  • Post-Authorization Safety Studies (PASS)
  • Post-Authorization Effectiveness Studies (PAES)
  • Drug Utilization Studies (DUS)
  • Risk Evaluation and Mitigation Strategy (REMS)
  • EU Risk Management Plan
  • Pregnancy Registries
  • Vaccine Registries
  • Expanded Access Programs (EAPs)
  • Label Expansion Studies

Real world expertise

To best support your research, IQVIA nurtures extensive scientific affiliations and maintains a strong commitment to research excellence. We are active partners and participants with OMOP, ENCePP, EUnetHTA, IMI, the Department of Health and Human Services, and maintain numerous academic affiliations. We help you meet regulatory needs, using RWE to accelerate approvals and label expansions in the U.S. and EU.

Related solutions

​Post Authorization Safety Studies with Nancy Dreyer
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