The need for greater clinical transparency has grown exponentially with the rapid increase of content, data, and clinical complexity. With the ICH E6 guidelines coming into effect earlier this year, it becomes even more critical for organisations to ensure they have implemented the business processes and the systems to properly track and manage content, identify anomalies within their clinical data set, and ensure inspection readiness. The breakfast will be hosted by Medidata in Munich on 25th of January from 7.30 - 10.30, and featuring ICH E6 industry expert, Andy Lawton and eTMF industry expert Frederico Braga.
During this session, we will discuss
- Best Practices for adherence of the ICH E6 guidelines
- Risk based monitoring strategies to ensure inspection-readiness and clinical data quality
- Methods for clinical data & content collaboration that maintain inspection readiness
- A real-world case study
The goal of this session is to provide a forum for sharing best practices, insights, and new techniques to ensure greater data and content transparency, and ICH E6 compliance.