Monday, April 1, 2013

Are we making progress in streamlining drug development?

  
Wednesday, June 26
 
Collaborating to Streamline Drug Development: Are We Making Progress?
In this forum, leaders of two of the best known initiatives – TransCelerate Biopharma Inc (TransCelerate) and the Clinical Trials Transformation Initiative (CTTI) – will provide a status report on current projects, with additional perspectives provided by representatives of the FDA, CROs, and research sites.
 
TransCelerate’s Collaborative Approach to Risk-based Monitoring: The Methodology
TransCelerate BioPharma Inc. (TransCelerate) developed a methodology for monitoring that shifts monitoring processes from an excessive concentration on source data verification to comprehensive risk-driven monitoring. This philosophical shift in monitoring processes employs centralized and offsite mechanisms to identify and monitor important study parameters holistically, and uses adaptive onsite monitoring to further support subject safety and data quality.


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