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… US and many European countries as risks and benefits, patient-centricity, and comparative effectiveness continue to … and retention Statistical analysis plans Reports and publications Data Collection and Management Depending upon … the following technologies: Laptop and tablet applications Electronic data capture (EDC) via the web Smartphone data …
… Patient-Centered Outcomes Assessment Whether your goal is to … and support Conduct clinical trial exit interviews Support electronic data capture and other modalities Develop and … of clinical outcome assessments (COAs), including patient-reported outcome (PRO), observer-reported outcome (ObsRO), …
… to support your asset. You can develop insights into the patient experience by linking patient-reported outcomes with clinician-reported outcomes. It's … of results Support for scientific presentations and publications And each step will be delivered with the rigor …
… Analysis of Heterogeneity of Treatment Effects for Patient-Centered Outcomes Let us help you understand your drug’s potential for … - Identify and define unique responders - Identify patient-reported outcome items/subscales - Power Phase II and recruit …
… RWE Studies Using Primary Data Collection To meet the requirements of risk management … studies can help you: Understand the natural history of a disease and its treatment Quantify and characterize product … effectiveness of a health care intervention Understand outcomes from the perspective of patients, physicians, and …
… PRO instruments and other types of COAs to assess health outcomes, such as symptom severity, health-related quality of life, functional status, and patient satisfaction for use in clinical trials involving … including regulatory submissions, reports, and publications Support to secure regulatory acceptability of …
… Disease prevalence and public health impact Event rates Patient characteristics Treatment patterns and drug … and value of alternative treatments Validity of electronic database information to identify specific disease … for the study. Moreover, we develop and validate exposure, outcomes, and covariates through structured coding of data …
… Pharmacoepidemiology and Risk Management Regulatory Real-World Evidence Research Let us … the safety of your patients by examining and understanding disease indicators and using real-world evidence to support … development and post-approval activities. To understand disease distribution, risk factors, treatment patterns and …
… the product's safety and/or effectiveness using real-world data (RWD). This most often involves causal inference … of studies we have conducted using various data sources: Electronic medical records Administrative healthcare claims Disease-specific clinical registries Linkages of claims and …
… payer strategy, and health economics Literature Reviews: Disease, burden of illness, treatment pathway, epidemiology …