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… Surveys and Observational Studies Beyond the evidence standards set by … help you develop real-world evidence through a variety of study types—surveys, cross-sectional or longitudinal … and retention Statistical analysis plans Reports and publications Data Collection and Management Depending upon …
… to regulatory questions Negotiating post-approval study commitments Determining if a post-marketing observational study could address a safety issue of … among alternative approaches Selecting the appropriate data collection strategies and data source(s) among …
… for Regulatory-Grade RWE Among the hurdles for making your healthcare interventions available to patients is being … the product's safety and/or effectiveness using real-world data (RWD). This most often involves causal inference … on applications of the target trial emulation framework when exposures are sustained over time and thus require more …
… Observational Studies Analyzing real-world, observational data requires specialized statistical skills. Our … to design and analyze data from a wide range of study types, including surveys, cross-sectional or …
… RWE Studies Using Primary Data Collection To meet the requirements of risk management … of patients, physicians, or caregivers. Prospective observational studies can help you: Understand the natural … adjudication committees Steering committees Obtaining study approval from Institutional Review Boards and Ethics …
… Multi-Criteria Decision Analysis Most drug development and commercialization choices are complex. When you have multiple factors influencing a decision and you … target market or country. With access to clinical trial data, outcomes data, and published economic models, we can …
… Patient-Centered Outcomes Assessment Whether your goal is to support product claims, facilitate market … services to capture the patient voice in clinical trials, observational research, and clinical practice: Develop , … Conduct clinical trial exit interviews Support electronic data capture and other modalities Develop and support …
… data may be greater than you think. Unexplored trial or observational data may contain a goldmine of information to … more opportunities to get the most value out of your study, whether exploratory or pre-specified. After analyzing … of results Support for scientific presentations and publications And each step will be delivered with the rigor …
… Discrete Choice Experiments and Conjoint Analysis As a pharmaceutical or device manufacturer, your … and administer the survey: We recruit subjects for each study that are representative of the target patient … advocacy groups, patient panels, and social media. Analyze data and provide reports and manuscripts : We provide study …
… controlled group. However, some patients in your study will benefit more or less than the average. Who are … efficient methods allow patterns within heterogeneous data to emerge so subgroups can be examined separately to … working with data sources from clinical trials , observational studies , and registries . …