With SCiAN’s ISEPRO and LTFPRO systems, Sponsors can integrate/collect safety and/or efficacy data across multiple studies in a clinical program.
SCiAN’s PV-SAE team will:
- Develop and maintain long-term safety follow-up databases (e.g., gene therapy)
- Develop and maintain integrated global safety databases
- Evaluate and analyze Safety databases for safety signals
- Update IND Annual reports, Investigator Brochures