TrialAssure & Certara Joint Webinar: Authoring Clinical Documents with Downstream Regulatory Requirements in Mind

The completion of a clinical document is not the end of the road, but rather the beginning of the lifecycle of these documents. Their journey includes many additional stops such as clinical trial registries, marketing applications, and post-marketing disclosure requirements such as EMA’s Policy 0070 and Health Canada’s Public Release of Clinical Information (PRCI) initiative. The session will provide a high-level overview of this clinical document disclosure. We will offer practical tips and best practices around authoring with these future regulatory requirements in mind and we will discuss how technology tools are leveraged by downstream partners to ensure compliance with these regulatory requirements.

1. Define the regulatory requirements for transparent disclosure
2. Recognize and proactively minimize sensitive information in clinical documents through structured, lean and consistent writing techniques
3. Implement cross-collaborative consideration to develop clinical writing techniques adapted to leverage anonymization technology tools