Smarter Clinical Document Automation Now for your Transparency & Disclosure Requirements Later скачать в хорошем качестве

Smarter Clinical Document Automation Now for your Transparency & Disclosure Requirements Later

In partnership with TOPRA, this webinar will provide insights into how transparency and disclosure efforts are an integral part of medical writing for investigational drug submissions. Typically, sponsors receive requests from regulators at European Medicines Agency or Health Canada post-submission to share their clinical data publicly. However, they are often overwhelmed with the “who’s” and “how’s” of the cumbersome and costly efforts to meet these requests. They must effectively compile, and re-visit already published documents that may not be “transparency friendly”. Whether anonymizing data for maximum data utility or redacting it as company confidential information, it’s important that documents contain optimal data formatting and presentation from the start. This webinar will share an overview of how automation using advanced technology, allows the production of clinical documents with future disclosure in mind. Using patient narratives as a case study, we will show you how “transparency-friendly” presentation standards can be integrated into your process starting from initial medical writing. Our resident narrative and transparency and disclosure expert, Gabriella Mangino, will also discuss the possibility of producing clinical documents in both original and anonymized versions at the same time, facilitating meeting transparency requirements while reducing downstream costs later. Certara accelerates medicines to patients using proprietary biosimulation software and technology to transform traditional drug discovery and development. Its clients include 1,600 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries. Please visit us at https://www.certara.com/