Pharmacovigilance and Safety Services
IndiPharm provides safety services to support your clinical research and marketed products. Our focus on quality and western standards provide your organization with high quality safety reporting, efficiently meeting your regulatory and co-licensing partner timelines. Our team of health care professionals and safety data staff can provide a full range of services including:
Individual Case Safety Report (ICSR) processing for
clinical trials and spontaneous reports
- Receipt and book-in
- MedDRA and WhoDRUG coding
- Narrative writing
- Quality control
- Medical Review
- Regulatory, co-licensing and other manufacturer reporting
Safety Medical Writing
- Periodic Safety Update Reports (PSUR)
- Periodic Adverse Drug Experience Reports (PADER)
- Annual Safety Report (ASR)
- Drug Safety Update Reports (DSUR) — new regulations
