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END-TO-END SAFETY SERVICES

END-TO-END SAFETY SERVICES

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Patients’ safety is our clinical strength. At Wizard, helping the clients make the right decision is of paramount importance.

Wizard will help you with quality adverse event management in a highly cost effective manner and with great flexibility. We provide complete business process; customize the AEs /SAEs management process and have handled AEs/SAEs in every therapeutic areas including oncology, neurology, cardiology and other internal medicine therapeutics from expedited drug approval, drug launch support, risk management and signal detection.

Wizard uses right technologies for drug safety data management including proprietary software tools to ensure efficient workflows and streamline processes, such as dictionary updates.

Signal Detection

We offer expertise in post-marketing signaling and Pharmacoepidemiologic techniques:

 Auditing

  • Population at risk incidence/prevalence statistics
  • Literature review
  • Enhance risk management programs
  • Physician medical review and signal detection
  • Pertinent literature reviews and summaries
  • Label revision
  • Risk MAPs
  • Post-marketing safety studies [PASS] and study design and conduct of registries.

 Quality & Auditing

  • Drug safety project management
  • Standard Operating Procedure development and review Compliance
  • Process Improvement
  • Domestic and Rest-of-World Audit (21 CFR Part 11)
  • Audit- can identify inefficient processes, discover gaps in training or development, and determine safety system technology improvements.