NUCLEON is uniquely positioned with the legacy of excellence in patient safety with SOP’s driven safety process as per regulatory requirements. With use of advanced technologies, we optimize process for ICSR Processing, signal detection, PSUR, RMP, REMS & PVMF
- 24x7 Medical Information call center (MICC)
- ICSR - Case Processing
- MedDRA coding and coding convention strategies
- Medical assessment of individual cases
- Preparation of SAE case narratives
- Literature Surveillance
- Risk Management Plan
- Aggregate report writing (ASRs), (PSUR), (PBRER), (PADER)
- Signal detection Management
- QPPV Services