Capabilities & Expertise

We provide the full spectrum of pharmacoepidemiology and real-world evidence capabilities, combining methodological expertise, access to large healthcare data resources, and coordination of multi-site research networks to evaluate the safety, effectiveness, and use of medical products.

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Real-World Evidence Research & Consulting

We offer leadership and consulting for real-world evidence on the safety, effectiveness, andutilization of medical products using large healthcare datasets. This work supports regulatory, clinical, and public health decision-making across thelifecycle of drugs and vaccines.

Regulatory Research & Support

Our team conducts pharmacoepidemiologic studies designed to inform regulatory decision-making,including post-marketing safety surveillance, risk evaluation, and studiessupporting regulatory commitments for medical products.

Pragmatic Trials

We design and support pragmatic clinical trials embedded within healthcare systems and data networks. These studies evaluate interventions in real-world clinical settings, complementing observational research and generating evidence that reflects routine care.

Multi-Site Methods & Coordination

We design and coordinate multi-site studies across distributed health data networks. Through our leadership of the FDA Sentinel Initiative, our team has extensive experience harmonizing data, developing distributive analytic programs, and monitoring quality across multiple institutions to generate reliable evidence from diverse healthcare data environments.

Validation Studies

Reliable real-world evidence depends on understanding how well healthcare data capture clinical events and exposures. We conduct validation studies to assess data quality and measure the accuracy of diagnoses, procedures, and medication use in large healthcare databases.

Pregnancy & Mother–Infant Linked Studies

Our investigators have extensive experience studying medication safety during pregnancy using mother–infant linked healthcare data. Combined with our multi-site capabilities, we are uniquely positioned to address concerns of rare exposures and outcomes in pregnancy.

International Collaborations

Many important evidence questions require international collaboration. We partner with investigators and data networks worldwide to conduct multi-country studies that evaluate medical product safety and effectiveness across diverse populations.