Bright has an integrated pharmacovigilance team that is a part of the core services we provide. A team of highly trained and experienced staff members performing data entry, data review and medical review provide this function. The team is supported and monitored by the best international industry drug safety and regulatory consultants all of whom have many years' experience in both FDA and EU interactions.
Medical monitoring and safety database administration tasks include:
- Data entry (which includes missing information assessment and follow up)
- Data review (QC process)
- Medical review/medical monitoring of every SAE by qualified and experienced MDs
- SAE narrative production (in accordance with ICH E3 data elements, MedDRA terminology, and the approved template)
- Follow up of reported SAEs to resolution or stabilization