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… Surveys and Observational Studies Beyond the evidence standards set by … and prescribers understand the real-world use, value, and safety of your products. Observational studies are also … and retention Statistical analysis plans Reports and publications Data Collection and Management Depending upon …
… Observational Studies Analyzing real-world, observational data requires specialized statistical skills. … abstractions, and electronic medical records (EMRs). Registry and Database Analyses Our biostatisticians have …
… Database and Registry Research Within pharmacoepidemiology research, … regulatory real-world evidence, epidemiology, and/or drug safety questions. Database research can help you gain … Health Statistics surveys Optum* Regenstrief Institute* Surveillance, Epidemiology and End Results (SEER) cancer …
… Analysis of Heterogeneity of Treatment Effects for Patient-Centered Outcomes Let us help … the potential for additional labelling claims - Inform safety studies and reduce risks of adverse events Abandoned … working with data sources from clinical trials , observational studies , and registries . …
… data may be greater than you think. Unexplored trial or observational data may contain a goldmine of information to … research , health economics , and epidemiology and safety activities. Differentiate with Strategic Statistical … of results Support for scientific presentations and publications And each step will be delivered with the rigor …
… studies, and drug, vaccine, and medical technology safety and effectiveness enables us to align the right … study commitments Determining if a post-marketing observational study could address a safety issue of … as those to address issues of nonrandom assignment of drug treatment Providing training on epidemiology methods, …
… you can gain insights on: Burden (cost) of illness Cost of treatment Health care resource utilization Treatment patterns … treatments Disease prevalence and public health impact Safety studies Because we are “database agnostic” and have … range of data partners, including: Behavioral Risk Factor Surveillance System (BRFSS) CPRD Drug Abuse Warning Network …
… Real-World Evidence Research Let us help you ensure the safety of your patients by examining and understanding … Whether you’re looking for consulting advice ; database or registry study; prospective observational research ; a literature review ; or a risk …
… meet regulatory requirements for estimating the product's safety and/or effectiveness using real-world data (RWD). This …
… FORTEO® Post-Market Osteosarcoma Surveillance Program: Real-World Data Contributes to Label … men and younger adults, a prospective, single-arm, patient registry was required. Two comparative studies using Medicare … not increase adult osteosarcoma incidence in a 15-year US postmarketing surveillance study . JBMR, 2020, pp 1-8; doi: …