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… Using Primary Data Collection To meet the requirements of risk management programs, inform drug development and … adjudication committees Steering committees Obtaining study approval from Institutional Review Boards and Ethics Committees Managing study operations: Site recruitment Monitoring Incentive …
… to advise you on the best resource—or whether a database study is appropriate at all—to use to answer your particular … so you can confidently make good decisions based on your study’s results. Our process includes determining the … with a wide range of data partners, including: Behavioral Risk Factor Surveillance System (BRFSS) CPRD Drug Abuse …
… information that can help you understand and communicate risk tolerance from patients and other stakeholders to inform … can also help catalog issues that could arise in benefit-risk assessments . Additionally, the decision process can be …
… to regulatory questions Negotiating post-approval study commitments Determining if a post-marketing observational study could address a safety issue of regulatory importance within a risk management plan Designing studies to evaluate the …
Delphi Panels Image Having high-quality data to inform decision-making is critical to your product’s development and success. But sometimes, unanticipated questions arise, and you need information quickly. What do you do if the data you need is …
… Social Inequity Score Offers Precise Analysis of Social Risk Data The US Food and Drug Administration (FDA) recently … data science methods, and geospatial analytics in a risk adjustment framework. Featuring a supervised machine …
… analysis Our Approach From design to deliverables, publications , and ongoing support, we develop and validate … and transparent model Developing documents and publications to communicate the value of your product …
… more opportunities to get the most value out of your study, whether exploratory or pre-specified. After analyzing … Full-Service or As-Needed Statistical Assistance Available Study concept and design consulting Comprehensive data … of results Support for scientific presentations and publications And each step will be delivered with the rigor …
Causal Inference for Regulatory-Grade RWE Among the hurdles for making your healthcare interventions available to patients is being able to meet regulatory requirements for estimating the product's safety and/or effectiveness using real-world data (RWD). …
… and access the most appropriate database(s) for the study. Moreover, we develop and validate exposure, outcomes, … Institute Data* Nordic Countries Scandinavian Sarcoma Group Spain Aragon Institute of Health Sciences (IACS)* …