Writing and Implementing Statistical Analysis Plans (SAPs) - Domestic and International Guidance under ICH E9 2015 is a webinar that covers topics such as:
- Timing of SAP preparation: Advantages of starting early and staying on top
- The Dance: Relationship between the SAP and the Clinical Protocol
- Sections of the SAP, necessary and optional
- Regulatory considerations, ICH E9, E6, and E3
- Using the template to complete your SAP
- List of tables, formatting the tables
- Integrated Efficacy SAP
- Integrated Safety SAP
Writing and Implementing Statistical Analysis Plans (SAPs) - Domestic and International Guidance under ICH E9 2015 brings together:
- Project managers
- Clinical research managers
- Scientists and R&D personnel involved in evaluating efficacy of a new drug or medical device
- Marketing personnel in drug or medical devices companies
- Documentation
- Quality personnel involved in evaluating safety of a new drug or medical device
- Anyone involved in decision-making for clinical phases of drug or medical device development
- Anyone involved in writing or implementing a SAP
- Bio statisticians
