Systems Landscape Assessment And Roadmap Development

How We Helped a Global Biopharma Company Accomplish their Digital Transformation Aspirations in Pharmacovigilance

By The Numbers:

  • 100% Manual Processing
  • 5 sprints in 1 year
  • 7 countries globally
  • 97.5% compliance KPI
  • Trending towards 90% automated AE form intake


  • A global biopharmaceutical company needed to assess their digital landscape by determining the business effectiveness and future-state needs to prepare for the firm’s increasing technology demands and rapid growth.
  • The client required immediately actionable strategies to address gaps in PV Case Intake capabilities and inconsistent medical information handing processes.
  • The long-term strategy was to develop the future state systems’ landscape and a robust roadmap of digital initiatives consisting of an intelligent set of platform and tools with advanced automation (NLP, AI etc.) for Global Drug Safety, Medical Information, PSPs, Call Centers and LSOs worldwide.


  • SSI worked closely with the Business Leads, Application Owners, SMEs and R&D IT to assess multiple end-to-end processes and the overall digital technology stack.
  • The team conducted focused interviews with stakeholders across these groups to understand the pain points of existing processes and technologies and to pinpoint the root causes, often leading to serious compliance risks. Opportunities for quick wins were identified, that required low effort but resulted in immediate benefits for the business.
  • Through this global assessment, SSI identified significant process gaps, limitations in technologies, and missed savings opportunities. We prioritized and sequenced each digital transformative recommendation to develop a roadmap that was feasible, realistic and addressed the overall challenges, yet building for the future.


  • SSI helped the company identify the digital platform, tools stack and helped select the most capable vendor to fulfill their needs.
  • Developed the cost benefit analysis and business case for the individual phases of the transformation.
  • Redesigned manual and error prone processes to maximize the utilization of the new platform’s capabilities that reduced overall organizational compliance risk.
  • Partnered with the client to support the multi-phased implementation of the digital transformation that included decommissioning of inefficient systems, introducing new intelligence and automation, thereby reducing non-value add, repetitive tasks while increasing submission rates and reducing compliance risks.