The Interim Analysis Symposium 2017 covers topics such as:
- 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
The Interim Analysis Symposium 2017 brings together 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
