As well as individual case safety reporting, PRA prepare and submit a range of additional safety reports including:
- Annual Safety Reports (ASR)
- Periodic Safety Update Reports
- Periodic Adverse Drug Experience Reports
- Investigational New Drug (IND) Safety Reports
Our Drug Safety group works closely with Data & Programming Services and Biostatistics & Medical Writing Services to ensure that all relevant data are included within submitted documents. Our experience and expertise in reporting is reflected in the successful resolution of safety issues leading to a high rate of client retention.
PRA is also prepared for future reporting requirements including Risk Management & Life Cycle planning and Harmonized Safety Updates.