Safety Efficacy analysis is fundamental to the drug development process. PRA understands that successful safety/efficacy database integration requires a holistic assessment of the data to provide the best outcome. Our Drug Safety group works closely with the Analysis and Reporting group to provide clients with comprehensive safety reporting. Submission Management specializes in prospective and retrospective data integration for programs of multiple studies, including:
- Support of the harmonization of data and analysis standards
- Interim analyses for DMCs
- Independent unblinding
- Pooled analyses
- Integrated summaries
An Integrated Summary of Safety or Efficacy (ISS/ISE) generated by PRA is easily integrated into your Common Technical Document. PRA's Technical Publishing group uses industry standard Liquent InSight® Publisher for the assembly, management and publication of complex documents.