HealthCore
keyboard_backspace Safety & Epidemiology Safety & Epidemiology for Life Sciences
Speed and accuracy are critical when conducting studies to achieve regulatory objectives. Our team of pharmacoepidemiologists, clinicians, biostatisticians, and project managers provides high-quality epidemiologic research on time and on budget.

Stakeholder demands can be daunting. HealthCore provides guidance and support throughout the research process. We construct and validate our automated data and we understand how to navigate the complexities of real-world studies to generate timely answers that are high-quality, reliable, and cost-effective. We know the intricacies of real-world data which we effectively leverage for uncovering insights into safety and effectiveness. Our multidisciplinary team brings a broad range of scientific expertise and operational experience to safety and risk management studies in the pre- and post-marketing setting.

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Post-Marketing Requirements/Post-Authorization Safety Studies

We design and manage safety studies as the coordinating center for multi-database, multi-year studies and single database studies requiring more rapid completion. As an original partner in the FDA Sentinel Initiative, our commitment to realizing the potential of electronic real-world data allows us to fulfill industry needs and exceed regulatory requirements.

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Validation Studies and Machine Learning

Our researchers validate clinical endpoints by linking administrative claims data to medical records, cancer registries, the National Death Index, and other data sources. We use machine learning methods to develop predictive models that target health conditions of interest with greater accuracy and improve the validity of epidemiologic research.

CAPABILITIES
Project Management
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.
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
OTHER Life Sciences SERVICES
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on our Collaborations services.