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Intelligent Automation Opportunities in Pharmacovigilance

Rationale

Given the wide variety of global regulatory requirements, managing the volume, variety and velocity of Pharmacovigilance data presents a significant challenge. Operations that are repetitive in nature and of relatively low business value are ripe for automation to gain efficiencies and reduce costs.

The Intelligent Automation initiative focuses on identifying how intelligent automation technologies can be used to better support execution of Pharmacovigilance activities/processes. By conducting an impact assessment and working with global health authorities to verify risks/issues with their use, this initiative will provide guidance, as appropriate, on applications of new technology in Pharmacovigilance practice.

Benefits

Near term

  • Enhanced speed through automation
  • Greater consistency within a particular sponsor company’s case processing and reporting while limiting errors commonly associated with manual data processing

More efficient allocation of resources to address more immediate priorities

Longer term

  • Catalyst for third party innovation in intelligent automation

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