Sponsored: Smarter Clinical Document Automation

Sponsored: Smarter Clinical Document Automation
FREE SPONSORED WEBINAR - Smarter Clinical Document Automation Now for your T&D Requirements Later
Date:  19 July 2022
Time: 16:00 - 17.00 BST (GMT+1) 

Transparency and disclosure efforts are an integral, though often belated, part of medical writing for investigational drug submissions. Sponsors receive requests from regulators at European Medicines Agency or Health Canada post-submission to share their clinical data publicly, but are often overwhelmed with the “who”s and “how”s of the cumbersome and costly efforts to meet these requests. With time working against them, they must 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.

In this presentation, Certara will share how automation through the use of advanced technology allows for 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 beginning from initial medical writing. Our resident narrative and transparency and disclosure expert will also discuss the possibility of producing of clinical documents in both original and anonymized versions at the same time, thereby facilitating meeting transparency requirements and reducing downstream costs later.

Learning Objectives
Understand the work involved in meeting transparency and disclosure requirements / Gain a better understanding of the transparency initiative surrounding clinical document production / Recognize how automation can achieve “transparency-friendly” presentations or full data anonymization pro-actively

Medical writers/editors, Regulatory Affairs, titles containing: Transparency and Disclosure, Redaction, Anonymization 

Speaker: Gabriella Mangino

Gabriella Mangino has years of patient narrative production and project lead experience in the pharmaceutical industry. As a Product Manager at Certara|Synchrogenix, Ms. Mangino works with the commercial and services groups to help develop and improve the software that supports our technology-enabled authoring capabilities, including anonymization and redaction.

This webinar is sponsored by Certara|Insight Medical Writing.

Whilst TOPRA is running this webinar for Certara|Insight Medical Writing, this is not an endorsement of Certara|Insight Medical Writing, Certara|Insight Medical Writing's affiliates, employees or its products and services. TOPRA is also not responsible for the content or views expressed during the webinar.


19/07/2022 16:00 - 17:00
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