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,…
As AI rapidly reshapes the evidence landscape, health technology assessment (HTA) bodies are beginning to define clear expectations for its use in submissions. At CapeStart, we work closely with life sciences clients navigating these changes—especially those integrating GenAI into literature reviews, RWE generation, economic modeling, Joint Clinical Assessment (JCA) support, Clinical Evaluation Reports (CERs), Patient…
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…
