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… to identify, develop, and disseminate the utility data needed to achieve your product development and market … selection of a utility instrument and design of utility data collection in trials and observational studies to … such as NICE, SMC, CDR, and PBAC), value messaging , and publications A Team Approach Let our multidisciplinary team …
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 …
… potential risks? More importantly, do you have the right data to credibly demonstrate this to regulators, payers, … Once we have helped you develop a complete picture of your data, we can help you identify gaps to inform a strategy for … approach for synthesizing clinical trial and/or real-world data Implementing additional risk minimization measures, …
… for Major Depressive Disorder with Quality-of-Life Data Share on: May 18, 2021 Major depressive disorder (MDD) …
… clinical care, such as patient screeners and disease management tools. Our instrument-development services apply … including regulatory submissions, reports, and publications Support to secure regulatory acceptability of …
… Causal Inference Using Real-World Data: How Pharmacoepidemiology Studies Can Benefit From the … Martinez, MD, PhD As the availability of real-world data grows, opportunities to leverage it are growing … decisions. Related Services Pharmacoepidemiology and Risk Management Staff Members Julia Vila Guilera Xabier Garcia de …
… Pooled Data Analysis of Long-Term Treatment Effect OPPORTUNITY Our … over a longer period, using existing clinical trial data. THE CHALLENGE Our client had data from approximately 10 … including single-arm phase 2 studies, randomized phase 3 studies, and observational studies. While each individual …
… Outline Best Practices for Collecting Patient Experience Data During the COVID-19 Outbreak Share on: April 9, 2020 … collection and use of clinical outcome assessment (COA) data. They drew on current FDA recommendations for … threats to the validity of the research, and alternative data-collection methods for capturing patient experience …
… Observational Studies Analyzing real-world, observational data requires specialized statistical skills. Our … with RTI-HS outcomes researchers to design and analyze data from a wide range of study types, including surveys, … biostatisticians have experience with multiple real-world data sources including electronic medical records, …
… Sample size calculations Randomization Interim and final data analyses Clinical Study Reports (CSR) Support for … for the nuances of QoL, including examination of missing data. Our team of statisticians is well-versed in the … on different health outcomes. Even if patient-reported QoL data was not collected in your study, we can apply the …