Pharmacovigilance is our Focus

At WCCT, pharmacovigilance is our top priority.  Through extensive medical evaluation and review, we provide Sponsors with data that is clean and error free and reported in a timely manor.  Specializing in data capture, analysis, trend detection, and reporting, we work with our clients to conduct studies, analyze information, and prepare the appropriate reports. Our medical professionals work closely with pharmaceutical companies and CROs, providing support and expert advice during each phase of drug safety development and analysis process.

WCCT GLOBAL OBJECTIVES OF PHARMACOVIGILENCE

 –  Define the Expected Adverse Events (EAEs) based on preclinical development that  should be anticipated in first in human clinical studies and beyond

–  Design data capture methods for EAEs that can be used to determine

  • Scope of adverse event
  • Frequency of adverse event
  • Severity of adverse event
  • Relatedness of adverse event to study product versus underlying disease

–   Record adverse events in detail, capturing such information as

  • Dose, frequency and route of administration
  • Concomitant medications
  • Underlying conditions and predisposing characteristics of patient populations

–  Establish the Critical Safety Signals for phase I-IV Development and prepare for post-marketing pharmacovigilence as the drug is used in the general population

–  Inform the development of

  •  Investigators’ Brochures for each study
  •  IRB packages
  • Product Labeling
  • Consumer Information
  • Annual Reports

–   Differentiate Adverse Events in terms of

  • Severe Adverse Events
    • Expected versus Unexpected
    • Reporting requirements
  • New Onset Chronic Illnesses
  • Drug – Drug Interactions