Constantly changing regulatory demands. New ways to keep you one step ahead

Regulatory authorities are now increasing opportunities for you to provide real-world evidence of your products’ safety and effectiveness.  This changing environment can make your products more available to patients.  And we are here to help. 

Increase the effectiveness and efficiency of your safety studies. Our global scientific, RWE and operational experts are developing innovative methods for RWE study design and execution combining secondary and primary data directly from patients and physicians. 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

Our rich breadth and depth of global and local data assets expands your study options.

Our extensive scientific affiliations and commitment to research excellence - we are active partners and participants with OMOP, ENCePP, EUnetHTA, IMI, the Department of Health and Human Services, and others, and maintain numerous academic affiliations. 

Stay on top of growing regulatory demands. 

Video
​Post Authorization Safety Studies with Nancy Dreyer