Periodic Safety Reporting

PRA plans, prepares, drafts and submits across all therapeutic areas:

• Periodic Safety Update Reports
• Annual Safety Reports (ASR)
• Periodic Adverse Drug Experience Reports
• Investigational New Drug (IND) Safety Reports

Although content, formatting and the detail of data analysis vary between an ASR and an IND Safety Report, many elements are similar. This is reflected in the table below.

PRA regularly creates and submits ASRs and Annual IND Safety Reports for its clients. PRA's safety team draws upon this knowledge base for the design and implementation of future reporting requirements, such as:

• Developmental Safety Update Reports
• Risk Management & Life-Cycle planning
• Harmonized Safety Updates

We provide summary reporting services: Handling all aspects of preparation including data analysis, risk assessment and medical writing as well as performing full submission services to authorities and ethics committees. This experience and expertise is reflected in the successful resolution of safety issues leading to high client retention rate.