Toronto, Canada (PRWEB) April 21, 2014
Investigators, health authorities, and ethics committees need to be informed in a timely manner of new and updated SUSARs and SAEs, since these safety reports are an essential requirement for sponsors of clinical trials. Using an automated and secure electronic communication method for this notification has shown to improve patient safety and regulatory compliance, while reducing manual efforts and costs.
In this webinar, the challenge of the prompt reporting of a low or high number of SUSARs to Investigators in global and large-scale clinical trials will be addressed. Additionally, the speaker, Dr. Max Horneck, CEO, maxclinical GmbH, will outline a real-life implementation of a secure communication platform for SUSAR reporting in a mid-size pharmaceutical company.
The expectations prior to implementation as well as challenges during the implementation will be addressed. In addition, Dr. Horneck will discuss planning of the migration from paper to an electronic system, rolling out the technology to investigators and study stake-holders, integrating the solution into an eClinical environment, and setting up a compliant reporting system.
For more information on this webinar or to register, visit:Informing the Investigator: Implementing an Automated SUSAR System
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