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14th Annual Sentinel Initiative Public Workshop Share on: Tuesday, November 15 - Wednesday, November 16, 2022 Event webpage Bradley Layton, PhD, Director, Epidemiology at RTI Health Solutions is giving a presentation at the 14th Annual Sentinel …
Surveys and Observational Studies Beyond the evidence standards set by traditional clinical trials, well-designed and implemented surveys and observational studies can help you, your patients, regulators, and prescribers understand the real-world use, …
Psychometric Evaluation Our psychometricians have extensive experience conducting quantitative evaluations of COAs, evaluating their structure and demonstrating their reliability, validity, and responsiveness, as well as facilitating the interpretation of …
6 Takeaways on the AMCP 4.1 Guidance in Action Share on: March 12, 2021 Insights from Working with Newest AMCP Format Guidance During 2020 In December of 2019, the Academy of Managed Care Pharmacy (AMCP) released Version 4.1 of the AMCP Format for …
… develop the study protocol, create the data collection form (DCF), and obtain ethics approval. During the …
RWE Studies Using Primary Data Collection To meet the requirements of risk management programs, inform drug development and post-approval strategies, or answer epidemiologic questions, we can help you design and implement real-world evidence research …
Patient-Centered Outcomes Assessment Whether your goal is to support product claims, facilitate market access, or improve patient-clinician communication, our Patient-Centered Outcomes Assessment (PCOA) team provides a comprehensive set of services to …
JCA Strategy and Planning The launch of Joint Clinical Assessments in 2025 represents a significant change to the marketing authorization process in the EU. It's critical that drug and device developers become informed on the latest guidance to be …
… of Nutritional Epidemiology Share on: Tuesday, November 14, 2023, 1 - 5pm Event website Xabier Garcia de Albéniz will … and the Swedish Food Agency. Presentation Details: 14 November, 1:40pm The analyses of observational studies in …
Collaborative Regulatory RWE Research Through our Barcelona based team, we are a partner center of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) which is led by the European Medicines Agency. We are dedicated to …