Pharma Companies, Escape the Black Hole of the conventional!

The pharmaceutical industry lives and breathes innovation, yet the nature of its products, and their direct relationship to human health necessitates the most conservative and methodical levels of control and oversight, to meet compliance, as driven by stringent regulations. Conventional safety frameworks, manually intensive processes and legacy systems create barriers to efficiency and innovation for Pharmacovigilance (PV) safety. Many of the issues pertaining to the tasks related to intake of cases are further exacerbated as we straddle the worlds of analog (manual) and digital (automated) processes.


The irony of the duality of pharma: conservatism versus innovation

The nature of PV requires a conservative approach, and so often follows the technology and systems that support it. However, this conservatism creates its own challenges including:

  • barriers to innovation or to new efficiencies
  • missed opportunities
  • new risks

Given the conservative approaches to technology and the corresponding manual workload of most company’s PV safety practices, many of the potentially valuable channels of case/event information intake remain untapped.

Pharmacovigilance, under the perpetual pull of this black hole of conventionality, has lagged other fields in embracing smart automation, intelligent (case) intake, auto-coding, auto-assessment and augmenting human judgement and review with AI. Conventional PV systems remain mired in monolithic architectures, and require major customization to adapt to technologies like optical character recognition, natural language processing, and semantic coding and classification. Yet, in these challenges, lie great opportunities for process automation.


How can pharmaceutical companies future-proof their PV processes?

Driven by digital disruption and need for patient-centric care, there is a need for pharma companies to modernize all aspects of Adverse Event and Product Complaint management. Such a unified, configurable platform will enable pharma companies to improve speed, compliance and risk management for drug and device safety, while reducing costs and improving visibility.

Unless the industry embraces digital automation, it risks being pulled in to the black hole. We would be happy to hear your experiences and what you are contemplating to streamlining your PV systems and processes.

Download our whitepaper – “Case Intake and the Black Hole – The Need for Digital Automation”



Dan DiSantis

Dan DiSantis is a Senior Director for Virtusa, a global IT consulting company. As Senior Director with Virtusa’s BPM Healthcare Practice, Dan actively provides guidance around technology strategy and planning, business case development and program management to Payers, Providers, and Life Sciences companies in the Healthcare Industry. Dan has spent the past 30+ years working in the healthcare industry with experience in both BPM and ECM. Dan is a regular panelist and guest speaker.

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