HealthCore
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.

Safety & Epidemiology: Industries We Serve OUR RESEARCH POSITION

You need to be confident that your research questions are answered using scientific rigor to overcome challenges that are not easily addressed. Across all our studies, we curate the most appropriate research questions and identify the optimal study design and analytic approach to meet your specific needs.

Our multidisciplinary team combines medical science and a deep understanding of research approaches to arrive at the most accurate and actionable answers with efficiency and excellence.

Highlights
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Relationships
Our team brings a range of expertise and collaborations between industries and stakeholders to deliver the services you require.
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Expertise
We build strong teams by bringing together the right specialized expertise for your project.
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Unparalleled Data
Our experienced researchers can do more with large, complex, and linked data assets.
Safety & Epidemiology CAPABILITIES
Helping deliver full service project management under the supervision of formally trained PMs who have hands-on experience running prospective and retrospective research studies. Our project managers are the primary point of contact for our clients, and our collaborative teams are built to the size, scope, and duration of each project to deliver study needs within the study requirements.
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.
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.
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.
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.
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
Causal Inference for Real-World Evidence

Causal inference is used to answer cause and effect research questions and yield estimates of effect. These study design considerations and statistical methods address the effects of confounding variables and other potential biases, and allow researchers to answer questions such as, “Does treatment A produce better patient outcomes as compared to Treatment B?”

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on our Safety & Epidemiology services.