For the last several years, artificial intelligence in life sciences has largely lived in innovation labs and pilot programs—valuable but often disconnected from the workflows that actually drive regulatory approvals, market access, and clinical decision-making. In 2026, that changes. Our first prediction from MadeAi & CapeStart’s 2026 outlook, developed with insights from Angeline Dhas, Head…
Every professional in the life sciences knows the feeling: literature review is challenging, time-consuming, and above all, exhausting. This essential step in research can feel like a massive hurdle, slowing down innovation and consuming countless hours.
Recognizing this frustration, MadeAi developed MadeAi-LR, a powerful GenAI-enabled solution designed to transform the literature review process. It provides the…
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,…
Introduction Artificial Intelligence is redefining healthcare and life sciences. From improving patient care to accelerating drug discovery, AI is proving to be more than just a technological trend; it’s a critical enabler of innovation and efficiency. In this article, we explore real-world AI applications in clinical studies, pharmacovigilance, diagnostics, and medical operations. These use cases…
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…

