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… Regulatory Guidance and Support We can support you throughout your regulatory negotiations. Our team has negotiated with the …
… your patients, regulators, and prescribers understand the real-world use, value, and safety of your products. Observational … and retention Statistical analysis plans Reports and publications Data Collection and Management Depending upon …
… Assigning Treatment Strategy Using Real-World Data A Challenge of Real World Data: How to Assign …
… potential risks? More importantly, do you have the right data to credibly demonstrate this to regulators, payers, … analytic approach for synthesizing clinical trial and/or real-world data Implementing additional risk minimization …
… Real World Data Research Challenge: Assigning Treatment Strategy Share on: August 22, 2019 A Challenge of Real World Data: How to Assign Individuals to a Treatment …
… health outcomes, such as symptom severity, health-related quality of life, functional status, and patient satisfaction … for new COAs Integration of experts to ensure clinical relevance Focus groups and in-depth interviews with targeted … including regulatory submissions, reports, and publications Support to secure regulatory acceptability of …
… evidence in a particular disease or treatment area. High-quality literature reviews can help you: Establish … search and review and extracting results, our rigorous, quality-controlled processes consistently ensure high-quality … Reasons for Conducting To collect the most recent, robust data and viewpoints on a disease and its management To inform …
… Challenges can include complexity of methodology and data sets, ensuring alignment with scientific strategy, and … and Strategy Team Offers: Extensive experience developing publications in pharmacoepidemiology, patient-centered … tactical plans efficiently and effectively. The Complete Publications Experience RTI-HS partners with you to develop …
… HTA and Reimbursement Considerations for Orphan Drugs in European Markets HTA and … of evidence sources and techniques, including comparative real-world information, to bridge data gaps and address economic …
… Observational Studies Analyzing real-world, observational data requires specialized statistical skills. Our …