Come hear case studies of cloud-based monitoring and a conversation about how different stakeholders can cooperate to increase research effectiveness. Speakers will explore remote monitoring from the perspectives of the contract research organization, research site, and technology vendor. Learn about the impact of HIPAA-compliant, cloud-based subject binders, associate regulatory issues such as Certified Copy, and best practices for implementation.

Learning Objectives:

Facilitate regulatory compliant remote monitoring
Explain the role and importance of Certified Copy under FDA guidance and ICH-GCP E6 R2
Discuss best practices for handling cloud-based source and regulatory documents

Ron Carozza PharmD

CEO, C3 Research Associates

Appearances