MCC Data Management and Biostatistics Work Group members are working in a collaborative environment to review the Data Management and Biostatistics metrics in the MCC Clinical Trial Performance Metrics v1.2.
Work Group is exploring:
- The impact of ICH E6 (R2) on Data Management and Biostatistics metrics
- Data Management and Biostatistics metrics developed previously by the MCC and any updates / modifications needed
- The opportunity to measure new metrics using data from separate systems that industry members are now able to consider due to system integrations
- Establishing a “basic” metric set that can be used by most organizations and a more “advanced” metric set that can be adopted by organizations with more advanced systems and experience using metrics.
Work Group output will include:
- Data Management and Biostatistics process map showing the metrics
- Definitions of key terms
- Critical Success Factors and Key Performance Questions
- A Basic metrics set
- An Advanced metrics set
- Guidance on implementation
Work Group meetings:
Monthly meetings 2nd Tuesday of the month
Open space to share thoughts and ideas with your industry colleagues – be a thought leader!
For additional information about joining this Working Group, please contact Customer Service (firstname.lastname@example.org)