Marketing Applications/Integrated Analyses

Integrated analyses of clinical data expedite the regulatory review process and shorten drug development timelines. PRA's Analysis & Reporting Group is dedicated to the innovative thinking and uncompromising quality required to execute integrated analyses successfully.

Our main products are Tables Figures and Lists (TFL) sets, Clinical Study Reports (CSR) and Marketing Applications. A variety of other products and services are provided by the department:

• Integrate databases (e.g. CDISC - SDTM, ADaM)
• Integrated analyses of safety and efficacy
• Full/partial marketing applications; e.g., CTD/eCTD
• Regulatory meeting briefing packages
• Electronic submissions/Regulatory publishing
• Annual safety updates
• Meta analyses
• Submission coordination
• Submission life cycle management