safety

SAFETY MANAGEMENT

Through a team of dedicated and experienced Medical Monitors, we provide- highly credible inputs for the design of comprehensive study specific safety management plans, to ensure AE’s & SAEs are reported and processed accurately as per the regulatory guidelines.

The safety management services Include :

  • AE and SAE case receipt, coordination and processing.

  • Medical review of AEs and SAEs.

  • Preparation of safety narratives.

  • Perform expedited safety reporting.