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SSS International Clinical Research provides professional support for Pharmaceutical companies according to legal regulations. Our experienced safety officers can assist with complete safety services, including processing of individual reports on serious adverse events from clinical trials preparation of individual reports for expedited submission to health authorities and ethics committees. Our Safety Services • Safety monitoring plan • Provide international toll free SAE fax lines • Set-up of SAE Database • Management of SAE reports and SAE database • Reporting to investigators, health authorities and ethics committees • EUDRAVIGILANCE reporting of SUSARS • Writing of SAE narratives • SAE reconciliation • SAE reporting to DSMB and statistical group • Writing Periodic Safety Update Reports (PSURs) |



