Webinar - Online
In many rare and ultra-rare disease studies, sponsors do not have the luxury of choosing the countries where the study is conducted. They must use the sites where those patients are being treated, regardless of geography. Additional protocol criteria, such as treatment-naïve patients, or general prevalence of a disease by region may limit site selection even further, requiring the sponsor to open sites in countries that normally would not be considered for clinical trials.
Opening sites in countries where clinical trials are uncommon requires detailed knowledge of the host countries and the complex regulations they may impose, along with thorough site training in protocol and good clinical practices. In addition, monitoring and trial oversight must focus on getting every patient through the study with minimal protocol deviations and other issues to ensure data integrity.
Organization: Xtalks Life Science Webinars
Tue, Dec 01, 2015 - Tue, Dec 01, 2015