PRA has made a significant investment in technology to enable data streamlining and standardization and subsequent seamless and uncomplicated submission in eCTD or any other required format. Essential to our success in this area is the Global Analysis & Reporting group.
The Global Analysis & Reporting group comprises a team of industry experienced and therapeutically trained statisticians, programmers and medical writers. These professionals provide consulting expertise and support to clients from the first stage of protocol design to marketing authorization submission, regulatory approval, post-marketing surveillance and Phase IV studies. PRA also provides experienced project directors who manage the analysis and reporting of complex projects. All project directors have vast technical/industry experience and superb project management skills.
PRA’s Global Analysis & Reporting group supplies our clients with products and services in the following areas:
- Medical writing
- Data pooling and integrated analyses
- Regulatory submissions
- Electronic publishing
- Full data monitoring committee set-up, management and support
- Clinical Study Reports (CSR)
- Regulatory Applications (NDA/MMA)
- Data Monitoring Committee (DMC)