As the trend continues toward quicker and more conditional product approvals, our Worldwide EvidenceTM practice provides an essential mechanism for documenting product safety over the entire product life-cycle. Whether as a formal mandate from regulatory authorities or combined with a discretionary research initiative, our global experts can design and undertaken post-approval research programs to compile safety data in actual practice settings. We consult with our clients to determine the appropriate design, ranging from focused safety surveillance to broader measures that may include clinical effectiveness, cost-effectiveness, and quality-of-life. Together with our pharmacovigilance experts, we offer quarterly and periodic aggregate reports, trending analysis and ad hoc safety signal analyses, in addition to the review of solicited and spontaneously reported adverse drug reaction case data.

We offer expert consulting on the design and implementation of risk evaluation and mitigation strategies (REMS) and risk management plans (RMPS) with a niche skill set in global execution of integrated solutions, given the distinct differences between the major regulators in this area. We also serve as the safety department for companies lacking their own in-house resources and confidently manage the transition of IND compounds to marketed products. We interface seamlessly with our clients’ drug information services or provide clients an integrated solution of our own.

  • Post-marketing surveillance
  • SADR, spontaneous ADR processing and reporting
  • Serious adverse event (SAE) processing and reporting
  • Registries, phase IV trials
  • Lab and diagnostic test review
  • Periodic safety update reports (PSUR), annual and quarterly report preparation
  • Signal detection services
  • Trending analyses for labeling changes
  • ArgusTM safety database
  • REMS/RMP design and advisory consultation