Medical safety specialists

The SSS medical safety team is made up of physicians and pharmacologists qualified to provide expert know-how and professional support for our clients. We provide a full range of safety services including the processing of individual serious adverse event (SAE) reports and the clinical trials preparation of individual reports for expedited submission to health authorities and ethics committees.

Safety Management Services & Pharmacovigilance

Accurate and timely capturing and reporting of serious adverse events (SAE) is crucial for the success of a trial. Ensuring proper safety reporting procedures to sites, institutional review boards (IRBs) and competent regulatory authorities is of the utmost importance in protecting patients as well as the integrity of the clinical trial results. Our well-trained team has all the necessary credentials and experience to provide you with full-service drug safety support throughout your trial:

  • Safety monitoring plan
  • SAE database set-up
  • Management of SAE reports and SAE database
  • Reporting to investigators, health authorities and ethics committees
  • EudraVigilance reporting
  • Writing SAE narratives
  • SAE reconciliation
  • Medical monitoring
  • SAE reporting to DSMB and statistical group
  • Writing Periodic Safety Update Reports (PSURs)

Company News: Safety & Pharmacovigilance

News / 20.11.2017
Pharmacovigilance: the countdown is on
As early as 2010, the EU Regulation No. 1235/2010 kicked off a reorientation in drug safety. The aim was and is to create more transparency with standardized approval procedures and to provide faster and better information about drug safety. This November, the transitional period for the new version of the pan-European database ends.
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