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… tablet applications Electronic data capture (EDC) via the web Smartphone data collection and transmission Handheld …
… Webinar: Common Challenges & Solutions in Analysis of PROs in Oncology Clinical Trials Share on: Wednesday, March 21, … and interpreting patient-reported outcome (PRO) data for oncology trials can present unique challenges. Join us as our …
HTA and Reimbursement Submissions The reimbursement environment is constantly changing. Requirements vary between markets and need coordination across multiple areas to produce high-quality results. To help you achieve market access, our experts across …
PIE and Post-Approval AMCP Dossiers Image Pre-Approval Information Exchange (PIE) Materials Unapproved Medical Product Dossiers and Unapproved Use Dossiers An unapproved product dossier, or an unapproved use dossier, allows you to communicate key product …
… of Recent PRO Labeling by the FDA and EMA for Oncology Drugs Share on: Wednesday, March 13 - Thursday, … EMA and FDA Labeling Based on Patient-Reported Outcomes (PROs) A recent review of labels from drugs approved by the … the 2 regulatory agencies. Popular myths will be debunked, oncology studies inefficiencies will be exposed, and emerging …
… Trends in the Inclusion of Patient Reported Outcomes in Oncology Clinical Trials Margaret Mordin, MS Vice President, … Trends in the inclusion of patient reported outcomes in oncology clinical trials: analysis of clinicaltrials.gov … industry sponsored oncology trials included assessment of PROs. Over the last five years, the US FDA has advocated for …
… in various therapeutic areas, including rare diseases, oncology, and women’s health. The purpose of this article is … . Please reach out if you have any questions. Download a PDF of our Guidance Summary Image …
Information for Vendors to RTI Health Solutions Purchase orders are subject to all the terms and conditions set forth in the document as indicated and linked below (hereinafter the “Terms”). Vendor’s delivery of products, performance of services, or …
Added support for your real-world evidence needs Share on: October 28, 2019 New office in Lyon, France, enhances our capabilities in real-world evidence generation Real-world evidence plays a critical role in product strategy and healthcare …
… numerous recruitment techniques including working with sites, patient advocacy groups, patient panels, and social …