Analysis & Reporting

PRA International's Global Analysis and Reporting team specializes in the following areas:

• Biostatistics
• SAS programming
• Medical writing
• Data pooling and integrated analyses
• Regulatory submissions
• Electronic publishing

We service all stages of clinical trial management and drug development. Project teams are designed to support clients from the first stages of study design, regulatory submission, approval, post-marketing surveillance and Phase IV studies. Because PRA recognizes the challenges of integrating data from multiple studies and providing high quality marketing applications, we have a Submission Management Team within Analysis and Reporting Group. Submissions Management specializes in the development and reporting of integrated databases for regulatory submissions. This team provides the expertise to streamline preparation of marketing authorizations (e.g., NDAs, CTDs, MAAs).

Our goal is to use our over two decades of experience in these important areas to support clients with the highest quality deliverables possible, from a preliminary study design document all the way through to a final paper or electronic submission with the appropriate regulatory agency.