Skip to content Skip to footer
FDA Literature Review

FDA Literature Review Requirements: Leveraging AI into Your Literature Review Strategy

Understanding FDA Literature Review Requirements The FDA requires literature reviews to ensure that regulatory decisions are based on solid scientific evidence. This isn't just about compiling papers; it's about systematically searching, appraising, and synthesizing published data to demonstrate safety, efficacy, and compliance. These requirements span multiple domains, from drug approvals to medical devices and health…

Read More

Literature Reviews

A Smarter Way to Adopt AI for Literature Reviews in Regulated Environments

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,…

Read More

Literature Review

How to Evaluate GenAI-enabled Literature Review Platforms: A Buyer’s Guide to Transparency, Accuracy, and Compliance

The rise of generative AI (GenAI) is transforming how life sciences organizations approach evidence synthesis, regulatory submissions, and market access activities. As literature review workflows become more complex—and timelines more compressed—life science professionals are increasingly turning to GenAI-enabled platforms to streamline systematic literature reviews (SLRs), reduce manual burden, and scale evidence synthesis. However, evaluating…

Read More

AI Implementation

The Biggest Challenges to Implementing AI in Life Sciences

The promise of Artificial Intelligence (AI) in life sciences is undeniable—offering advancements in drug discovery, clinical research, and evidence generation. Yet, many organizations still struggle to implement AI effectively. To better understand these challenges, CapeStart conducted a survey of 104 life science professionals, asking them:  What are the top three barriers to success for your…

Read More

research

AI Strategy Readiness: Team Capabilities and Vendor Support Insights from CapeStart’s Life Science AI Research Report

Artificial Intelligence (AI) holds immense promise, but its successful adoption depends on two critical factors: whether teams have the capability to implement AI strategies and whether they can access the right vendor support. CapeStart’s Life Science AI Research Report sheds light on these questions, offering a deeper understanding of how organizations are navigating these challenges.…

Read More