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June 27, 2026Information Systems JournalOpen Access

Scalability of Digital Transformation in a Highly Regulated Environment: Lessons From Roche's Global Operations

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Authors

NANisreen AmeenVRVijay Reddi

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Overview

Practitioner paper examines how Roche scaled digital initiatives successfully in complex regulatory settings, highlighting key lessons.

Key Points

  • The aim is to explore how multinational organizations can effectively scale digital transformation while navigating regulatory challenges.
  • Conducted 26 semi-structured interviews within Roche, a global pharmaceutical company.
  • Examined two AI-enabled initiatives: AI-driven translation and robotic process automation for regulatory tasks.
  • Identified organizational development areas and mechanisms for scaling digital transformation.
  • Identified three key organizational development areas necessary for scaling: mindset for scaling pilots, standardization, and managing information under regulation.
  • Highlighted two mechanisms that facilitate scaling: impact assessment and visioning regarding information flows.
  • Outlined five practical lessons for organizations to effectively scale digital initiatives.

Cite This Study

Ameen et al. (2026) studied this question.

synapsesocial.com/papers/6a3f6972aea7db3c1954039bhttps://doi.org/10.1111/isj.70054
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Architecting Scalable Digital Transformation in Regulated Industries2026
  2. 2Architecting for Scale: Lessons from a Global Pharma Pilot Rollout2025
  3. 3Digital Transformation in Pharmaceutical R&D in a Midsized Company: Unlocking Innovation Through Human and Organizational Factors2026
  4. 4Leveraging Digital Transformation for Enhanced Risk Mitigation and Compliance in Pharma Manufacturing2024 · 17 citations
  5. 5Regulatory governance in lean digital transformation: institutional adaptation in digitally enabled operations2026