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. AI-powered literature reviews, combined with expert human validation, accelerate evidence synthesis while maintaining transparency, accuracy, and regulatory-grade quality.…
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…
Why the Industry is Testing the Wrong Thing The life sciences industry faces a growing paradox: organizations are investing heavily in AI, yet many evaluation methods fail to measure how these systems actually perform in real-world evidence synthesis workflows. Every week, new evaluations emerge, and task forces publish guidelines. Academic papers rank AI tools. Organizations…
How do you prepare a Clinical Evaluation Report (CER) without spending months on literature review and evidence synthesis? In this case study, MadeAi partnered with a medical device regulatory team to conduct a systematic literature review aligned with MDR and MEDDEV requirements. The team searched multiple databases, screened studies, extracted key evidence, and generated structured…
