Meghan Oates-Zalesky 
Though many organizations see the value of AI in literature reviews and evidence generation, not all can adopt AI in the same way. Some teams are ready for a web-based SaaS solution. While others, especially large pharma and regulated enterprises, face internal AI policy barriers, data residency requirements, and IT constraints that make SaaS adoption difficult, even when there is clear demand. When implemented effectively, AI can significantly reduce review timelines, improve consistency, and strengthen traceability across evidence workflows. Yet for organizations operating in stringently regulated environments—such as pharma, biotech, and healthcare—AI adoption often stalls. The challenge isn’t whether AI works, but whether it fits within existing regulatory, quality, and governance frameworks. 
Why AI Adoption Stalls in Regulated Settings
Traditional AI deployments, particularly SaaS-based models, raise legitimate concerns for regulated teams. These include data residency and privacy, validation and auditability, change control, and long-term operational risk. Even high-performing AI tools can fall short if they cannot align with GxP expectations, ALCOA+ data integrity principles, or internal quality systems. As a result, many organizations delay adoption—missing out on clear efficiency and quality gains.Consider the Build–Run–Own Model
The Build–Run–Own model offers a structured alternative designed specifically for regulated, evidence-driven environments. Rather than treating AI as a black-box tool, this approach enables organizations to adopt AI as a controlled, validated, and ultimately owned capability. 