Interim Analysis Symposium 2017

Topics

• Submission regulations through the use of FDA guidances
• Gray areas surrounding the way interim data is collected and analyzed to assess efficacy,futility or safety in adaptive clinical trials
• Selecting proven benefit - risk frameworks
• Devise practical solutions to common and nuanced confidentiality challenges
• Best practices for data monitoring committees to enhance the quality of data assessments
• The integrity and validity of clinical trials through the development of firewalls
• Lessons learned by peers through the observation of industrywide case studies

Who should Attend

Attendees from generic pharmaceutical and biotechnology companies with responsibilities in

• Statistics
• Interim Analysis
• Trial Design and Development
• Biostatistics and Epidemiology
• Adaptive Clinical Trials
• Clinical/Medical Development
• Clinical Operations/Research/Management
• Regulatory Affairs, Policy and Compliance
• Data Analysis/Data Management
• Quantitative and Scientific Affairs
• Drug Safety
• Medical Coding
• Product Development
• Medical Research

In addition to:

• Data Coordinating Centers
• Data Monitoring Committee Providers
• Electronic Data Capture Vendors
• Contract Research Organizations
• Statistical Consultants
• Medical Informatics/Data Service Providers