Safety reporting on suspected unexpected serious adverse reactions (SUSARs) and serious adverse events (SAEs) is an essential requirement for sponsors of clinical trials. It is very critical that Investigators and ethics committees need to be informed immediately of new SUSARs, as well as updated information on previously reported SUSARs.
To manage this process is a time consuming and expensive challenge that increases capacity and increase the risk of non-compliance for the sponsor. Using secure and automated electronic communication can improve patient safety and regulatory compliance, while reducing manual efforts and costs.
Watch this 30-minute webinar to understand how to take the pain out of regulatory compliance for SUSAR:
1. Introduction to the updated SUSAR process
2. Timely reporting of SUSAR’s
3. Regulatory compliance requirements for SUSAR
4. Using automation and communication to take the pain out of regulatory compliance
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