|
|
|
Safety OperationFMD offers safety handling service that is fully compliant with ICH guidelines. Specifically, FMD provides AE/SAE collection, review, assessment and reporting services. In addition, FMD would also provide DSMB (data and safety monitoring board) handling and signal detection services. Safety coding will be handled by clinical staffs that have hands-on experience in MedDRA and other coding systems. |