Integrated Analysis of Safety and Efficacy

PRA understands that database integration requires a holistic assessment of data. PRA's drug safety group works closely with PRA's Analysis and Reporting team to provide our clients with comprehensive safety reporting. Submission Management specializes in the 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 can be easily integrated into a Common Technical Document. PRA's Technical Publishing group uses Liquent InSight^® Publisher for the assembly, management and publication of complex documents. Liquent InSight^® Publisher is the industry standard for these activities. PRA uses ISI Toolbox Pharma to produce "submission-ready" ISS/ISEs.