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… records Administrative healthcare claims Disease-specific clinical registries Linkages of claims and registries Sharing … navigate their way through the emulation of target trials, with emphasis on limitations and best practices. Our … Sessions on specific analytic and design features for a clinical audience. Workshops used for internal training of …
… Joint Clinical Assessments: Racing to the Finish Line at What Cost? … its requirements. The deadline for dossier submission is within 100 days of the request. The scope and requirements of … that cannot be addressed in a scientifically adequate way within the 100-day deadline. This could especially be the …
… HRQOL Data Analysis Pooled Across Multiple Trials OPPORTUNITY Our client wanted to understand if their … in 3 different tumor types using data collected across 4 clinical trials. CHALLENGE Individual trials that examined time to …
… We are uniquely positioned to provide expertise in clinical trials combined with broad experience across an array of … innovative statistical methods to individual or pooled clinical trial data and accounting for confounding in …
… identification and handling of EU personal data, data subject rights, confidentiality, data archive and … leader to confirm that the data will reside at all times within the EU or UK and be accessible only to RTI-HS staff or … on dedicated project shares on secure network servers within Europe or RTI’s data center or in approved cloud …
… all major therapeutic areas . Our diverse background in clinical research, regulatory submissions, epidemiology … could 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 Performing regulatory landscape …
… set of services to capture the patient voice in clinical trials, observational research, and clinical practice: Develop , validate , and culturally adapt …
… Emergence of the Joint Clinical Assessment in the European Union Anne Heyes, MBA … in the legislation. The European HTAR will introduce joint clinical assessments and joint scientific consultations, … medical needs as well as the use of comparative clinical trials, among other factors. How is the Pharmaceutical …
… which treatments are helpful or harmful. Randomized Clinical Trials Randomized clinical trials are the gold standard to estimate causal …
… environment and reimbursement issues pertaining to clinical outcome assessments (COAs), we work with you to … or development is needed Conceptual model development Clinical trial design and consulting to optimize the analysis …