Capabilities & Expertise

We combine methodological expertise, large-scale healthcare data resources, and multi-site research infrastructure to deliver real-world evidence that supports regulatory, clinical, and public health decision-making.

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Multi-Site Methods & Coordination

Pioneers and leaders in large-scale distributed data networks, with methods developed through decades of multi-institutional research experience.

We design and coordinate studies across healthcare data networks to support robust, multi-institutional evidence generation at scale.

Validation Studies

Critical to ensuring reliable outcome definition and data quality in regulatory and applied real-world evidence studies.

We conduct validation studies spanning algorithm development, structured chart abstraction, and quantitative bias analysis to ensure definitions are fit for purpose.

Pregnancy & Mother–Infant Linked Studies

Deep expertise addressing rare exposures and outcomes in pregnancy, supported by multi-site linked data resources and scalable infrastructure.

We design and execute pregnancy and mother-infant linked studies to support regulatory and post-approval decision-making in this specialized population.

Real-World Evidence Research & Consulting

Decades of leadership in regulatory and applied research, delivering credible evidence across the full product lifecycle.
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We design and deliver real-world evidence studies to evaluate the safety, effectiveness, and utilization of medical products.

Regulatory Research & Support

Over 40 years of regulatory research experience, including leadership of the FDA Sentinel Initiative since its inception in 2009.
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We conduct studies to inform regulatory decision-making, including PASS, PMC, PMR, and post-approval safety surveillance.

Pragmatic Trials

Prospective evidence generation within routine care environments, complementing observational research at scale.
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We design and implement pragmatic trials embedded within health plan and multi-site data networks, evaluating interventions in real-world clinical settings

International Collaborations

Translating evidence across populations through international research collaborations.

We partner with investigators and data networks worldwide to conduct multi-country studies evaluating safety and effectiveness across healthcare systems.