SLSC can support you with developing the following documents:
- Medical Safety Assessments of clinical safety topics
- Medical impact assessments (MIA)
- Development safety update reports (DSUR)
- RSI section of the Investigator’s brochure (IB)
- Guidance to investigators section of the IB
- ADR sections of the USPI/SmpC
- Periodic benefit-risk evaluation reports (PBRER)
- Answers to HA questions
SLSC can support you with the review of:
- Blinded and un-blinded aggregated clinical data in ongoing studies
- Tables, listings, and figures of completed studies
- Patient narratives
- Serious and non-serious adverse events
SLSC can support you with the organisation of:
- Scientific advisory boards
- Independent safety monitoring boards