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