Why Evidence for Rare Disease Matters AI and real-world evidence (RWE) are reshaping the path from laboratory discovery to regulatory approval. Their convergence matters most for patients who can't afford to wait. For patients with rare diseases, waiting for treatment can mean years of uncertainty. In the United States, a rare disease is generally defined…
SLR vs. Meta-Analysis: An Overview You've just received a research question from your stakeholders. They want to understand the effectiveness of a new therapeutic intervention across the published literature. Naturally, your next thought is: should we conduct a systematic literature review (SLR) or a meta-analysis? In healthcare and life sciences, this question sits at the…
How do you prepare Clinical Evaluation Reports (CERs) without spending months reviewing clinical literature? In this case study, MadeAi partnered with a medical device manufacturer to conduct systematic literature reviews supporting Clinical Evaluation Reports (CERs) for three vascular devices. Using AI-assisted search, explainable screening, structured data extraction, and SME validation, the team generated submission-ready clinical…
Drug repurposing has the potential to deliver new therapies faster and at a fraction of the cost of traditional drug development. However, identifying meaningful opportunities remains difficult, with valuable signals often hidden across thousands of research publications. MadeAi combines AI-powered literature review with expert human validation to accelerate evidence synthesis while maintaining transparency, accuracy, and…
How do you prepare Periodic Safety Update Reports (PSURs) without spending months manually reviewing clinical literature and safety evidence? In this case study, MadeAi partnered with a medical device manufacturer to conduct a systematic literature review supporting PSUR requirements. Using AI-assisted screening, expert validation, and structured evidence extraction, the team streamlined the review process and…
How do you screen thousands of abstracts with transparency, reproducibility, and submission-ready outputs in a fraction of the time? In this case study, MadeAi partnered with a leading pharmaceutical HEOR team to design and validate an AI-powered pipeline for systematic literature review. Using a structured, PICO-based framework, the team screened thousands of records across multiple…

