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Gain active drug safety, pharmacovigilance and risk management from SGS.

Clinic regulatory

Patient safety is paramount at every stage of your product lifecycle. We provide comprehensive and flexible solutions for the active management of drug safety, pharmacovigilance and risk management during the complete lifecycle of a medicinal product. Our pharmacovigilance team consists of multilingual MDs, PhDs and pharmaceutical scientists with broad therapeutic expertise that work according to the latest regulatory requirements.

Why choose SGS pharmacovigilance and drug safety services?

Our team of experts provides you with:

  • Qualitative and comprehensive end-to-end case processing
  • Set-up and management of the in-house safety database for all phases of clinical trials and post-marketing pharmacovigilance
  • Expedited reporting to heath authorities of unblinded SUSAR reports, ensuring the protection of the blinding of the study team
  • Business continuity and in-time safety reporting
  • Documented quality control checks to guarantee audit-proof safety reports
  • Input to signal detection, such as review of data, coordination of signal detection meeting and writing of meeting minutes
  • Up-to-date information on country-specific regulatory requirements
  • Tailor-made, cost-effective safety systems for small and mid-size companies

Get comprehensive pharmacovigilance and drug safety services from a world-class provider

We offer you unrivaled expertise in pharmacovigilance and drug safety.

Our range of services includes:

  • Development and implementation of pharmacovigilance systems for investigational and registered products
  • Customized safety plan and safety data exchange agreement
  • Set-up and management of in-house safety database (Oracle Argus Safety)
  • Individual Case Safety Report (ICSR) management
  • Literature search (Elsevier Embase), and identification of ICSR and safety issues
  • Safety related report writing, such as case narratives, Development Safety Update Reports (DSUR), Periodic Safety Update Reports (PSUR), safety summaries, benefit/risk assessments, clinical overviews and more
  • Medical review of safety reports and documents
  • Tracking of regulatory intelligence for safety reporting and compliance
  • EudraVigilance support
  • Safety reporting to Health Authorities (HA) and Ethics Committees (EC) / Institutional Review Boards (IRB)
  • Signal detection and ongoing safety evaluation
  • Tailored coordination of Data Safety Monitoring Board (DSMB) activities – Independent Data Monitoring Committee (IDMC), Endpoint Committee or other
  • Pharmacovigilance consulting

To discuss your pharmacovigilance and drug safety requirements, contact us today.

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Early Phase Clinical Trials Maxims

Discover the early phase clinical trial drug development fundamentals through our Maxims.

Download the Maxims