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Safety & Epidemiology
Safety & Epidemiology
OUR APPROACH

When faced with the gamut of regulatory requirements, we partner to provide the expertise you need to navigate with speed and efficiency so you can deliver answers with clarity and confidence.

When you have complex safety questions, we can provide the scientific guidance and data resources necessary to address your most complex safety questions. Often these are time critical questions, and our deep experience with claims data permits us to respond quickly, with rigor and accuracy. We apply pharmacoepidemiology and database research expertise to a robust data asset to deliver and translate deep and valuable insights critical to adoption and approval.

Industries We Serve Safety & Epidemiology CAPABILITIES
Single and Multi-Database Post-Authorization Safety Studies
We have extensive experience working with data partners and regulators to design and efficiently manage large studies to meet regulatory requirements on time and on budget. New drugs often require multiple databases to study events that require hands-on familiarity with automated data. We provide database expertise with medical claims, pharmacy claims, and laboratory results in collaboration with healthcare providers to ensure the validity and quality of the data. Scientific expertise integrating and harmonizing diverse data types and sources gives us an unparalleled understanding of the nuances of automated data assets.
Risk Evaluation and Mitigation (REMS)
Providing the expertise to address FDA required strategies to inform and support the safe use of your product. With access to commercially-insured and Medicare-advantage patients, combined with access to community-based providers and sites, we offer a comprehensive understanding of the knowledge, attitudes, opinions, and perceptions regarding medications in the real world setting.
Validation Studies and Machine Learning
We validate claims using medical records, disease registries, patient and provider surveys, focus groups, clinical oncology data, and the National Death Index. Our team of research experts builds predictive models in multidimensional electronic data to identify health outcomes and indications and reduce bias from misclassification. We use supervised machine learning to deliver stronger studies with more reliable results.
Medical Record Review and Abstraction
When a more complete clinical picture is needed we use in-depth medical record review by clinical experts. We start with your objectives for the review and apply a standard, step-by-step methodology documenting key medical details to inform the development of healthcare recommendations and guidelines.
Survey Based Research
We deliver actionable evidence to better guide current disease management and to assist in the development of new therapeutic or biomedical technologies. Through structured, semi-structured, or cognitive interviews and focus groups, we provide access to a level of patient and clinician-reported information not found in other large-scale sources of health data including medical and pharmacy claims, paper-based and electronic medical records, and disease registries.

featured thought leadership
Safety & Epidemiology
Predictive Modeling and Machine Learning: Sharpening the Focus of Real-World Evidence in the Age of Precision Medicine

Real-world evidence can usefully support precision medicine and faster regulatory approvals. The use of statistical methods to develop better case-identifying algorithms enables use of claims databases to study rare diseases and other targeted indications as well as more valid outcome ascertainment for safety and effectiveness research.

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on our Safety & Epidemiology services.