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…

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…

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…

How do you screen thousands of abstracts with transparency and reproducibility using minimal training data? In this case study, MadeAi partnered with the Roche HEOR team to design and validate an explainable AI pipeline for title and abstract screening in a systematic literature review. Using a structured PICO-based framework, the team screened over 3,300 abstracts…

How do you turn unstructured social media conversations into publication-ready evidence in just 4 weeks? In this case study, MadeAi partnered with the CSL HEOR team to identify and curate hereditary angioedema-related conversations from public online sources, with insights supporting a Value in Health Journal article. Using a structured social media listening approach, the team analyzed 3,069 records to uncover…