Search
Use the filters to narrow by type of content
Looking for a Publication? Search the bibliography for: publications fundamentals us regulatory affairs
… Regulatory RWE Consulting As researchers with advanced … areas . Our diverse background in clinical research, regulatory submissions, epidemiology studies, and drug, … and medical technology safety and effectiveness enables us to align the right approach with your objective. Our …
… Causal Inference for Regulatory-Grade RWE Among the hurdles for making your … interventions available to patients is being able to meet regulatory requirements for estimating the product's safety …
… Collaborative Regulatory RWE Research Through our Barcelona based team, we … for the registration of pharmacoepidemiological and regulatory RWE studies. Susana Perez-Gutthann has been …
… Regulatory Guidance and Support We can support you throughout your regulatory negotiations. Our team has negotiated with the …
… Regulatory Priorities, Real-World Evidence, and the Safety … Initiative plays a key role in ensuring that in the US. The Sentinel Initiative, launched in 2007 by the US Food and Drug Administration (FDA), is a national …
… Instrument Development In accordance with regulatory guidelines and expectations in the US and Europe, we can help you develop new COAs and modify … including regulatory submissions, reports, and publications Support to secure regulatory acceptability of …
… rights of data subjects. The RTI-HS Office of Legal and Regulatory Affairs, Office of Quality Assurance, and RTI's Global … and information submitted by a vendor working with us in support of our proposals and contracts with clients or …
… Publication Management and Medical Writing Publications are critical for the dissemination of your … scientific and medical research. When you partner with us on your research projects, our expert team of medical … Publication Planning Managing deadlines for conferences, regulatory submissions, and internal milestones is an …
… Develop and support measurement strategies Provide regulatory guidance and support Conduct clinical trial exit … Team Our team includes more than 30 researchers in the US and Europe with significant industry experience. … projects involving the development, implementation, and regulatory support of clinical outcome assessments (COAs) …
… In-Person Course: Regulatory-Grade Causal Research in Pharmacoepidemiology … Barcelona Spain Learn to Use Target Trial Emulation for Regulatory Real-World Evidence Generation Registration for … and implement the target trial emulation framework in regulatory studies that use real-world data (RWD). We will …