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… to regulatory questions Negotiating post-approval study commitments Determining if a post-marketing … address a safety issue of regulatory importance within a risk management plan Designing studies to evaluate the effectiveness of risk minimization measures within a risk management plan …
… Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE); August 29, 2017. Montreal, Canada. … that are of interest (epilepsy and mood disorders, in this case), be commonly used and have, ideally, a benign safety … and, more recently, for cognitive problems, for infants exposed in utero. Taking all of this into consideration, we …
… 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 …
… VAC4EU , the Vaccine Monitoring Collaboration for Europe study network, we are helping to increase the availability of …
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). …
… of CV illnesses. Recent projects have included: Benefit-risk preference studies Cohort and case-control studies Cost-utility analysis Database analyses using …
… of GI illnesses. Recent projects have included: Benefit-risk preference studies Cohort and case-control studies Consulting on drug development from …
… Determining Effectiveness of Risk-Minimization Measures Impact of Risk Minimization … Cilostazol's use was restricted to second-line therapy in case lifestyle modifications, including smoking cessation and … such as aspirin or clopidogrel. In this observational study, RTI Health Solutions collaborated with research …
… HCPs towards hepatitis A and B vaccination of adults at risk. Shamarina D, Sluga-O'Callaghan M, Dave V, Davenport E, …
… the overall survival of patients with chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL) comes from … research helps provide such evidence to the stakeholders.” Study measures and endpoints were as follows: Baseline … and economic burden in patients with chronic lymphocytic leukemia receiving systemic therapy: real-world evidence from …