Adaptive Trial Execution : Making it work in the real world.
With more than a decade of experience designing, executing and managing adaptive clinical trials around the world, Aptiv Solutions has the tools, staff and expertise to enable Sponsors to successfully implement adaptive approaches in their development programmes.
Adaptive Monitoring and Execution Expertise, Including:
- Continuous adaptive monitoring
- Continuous query generation
- Continuous medical coding
- Statistical programming
- Loading of current data set
- Programming of mock-tables and listings
- Preparation of SAS programs for determination of protocol deviations
- Initiation and loading of snapshot of current data
- Generation and review of blinded and unblinded analysis
- Preparation of Statistical Analysis Plan
- Preparation of Biostatistical Report and forwarding to all members of the DMC
Real-time access to interim data (interim reports can be provided to the DMC within 3 working days after Database lock)