Pharmacovigilance

With SCiAN’s ISE^PRO and LTF^PRO 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