Event categories: SCDM

Most companies now heavily scrutinize their clinical-trial data in response to ICH E6 R2 and the impending ICH E6 R3. And yet, despite heavy scrutiny, not all companies approach clinical-trial data review with the same degree of rigor, even though how a company manages its data can significantly impact the success of its clinical trial.
Please join us for a live webinar to learn how clinical study teams can maintain good clinical data review by efficiently tracking the data review process, communicating its progress, and monitoring utilization to ensure safety and efficacy in a clinical trial.

Society for Clinical Data Management

The SCDM Annual Conference exists to drive progress across the world and to support the evolution from Clinical Data Management toward Clinical Data Science. The theme for the 2021 conference is “Future Now: v2.021”.

This training session describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications. What the regulations mean is described for all four primary compliance areas: SOPs, software features, infrastructure qualification, and validation. It gets you on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance.

The impact of the pandemic may result in a change in the way we live in future; so understanding the capabilities, technology and opportunities on virtual possibilities of conducting clinical trials by ensuring the Design, Conduct, Monitoring and Analysis enables adapting to this paradigm. It thus is a great opportunity for all to be part of this SDE to add to our knowledge as clinical research professionals.