Safety Management

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)