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Pharmacovigilance – Signal Detection

GAP provides the full, or bespoke, services for signal detection. Currently, signal detection is made mandatory in Europe and the U.S. to review and generate the potential signals that comes across in the discovery of the adverse event relationship. We understand the importance of risk-benefit ratio, signal triage algorithm, good Pharmacovigilance practice which follows the compliance guidelines. Our physicians bring information from the various sources, including the organization data (safety, registries, clinical, and sales) and outside data sources (FDA AERS, WHO Vigibase). GAP contented with:

  • Tools for data mining and statistical analysis which helps in identifying potential signal.
  • Access to various data sourcing like company data, literature source, studies or external data source.
  • Expert with experience in generating and identifying potential signal.
  • A team who is experienced and expertise in Multi-Item Gamma Poisson Shrinker (MGPS), Bayesian Confidence Propagation Neural Network (BCPNN) and Proportional Reporting Ratio(PRR).

Contact us for more information.