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…
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,…
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…
As the demands for faster, more accurate, and scalable literature reviews rise in life sciences, AI is no longer just a future promise—it’s a proven performance driver. Systematic literature review (SLR) teams, especially in HEOR and medical affairs, are adopting GenAI platforms not just for experimentation but to solve long-standing bottlenecks in screening, extraction, and…
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…
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.…
