regulatory-grade-data
(4)
Dandelion Health
Dandelion Health is a New York-based clinical AI and real-world data company that turns de-identified patient records from a network of U.S. hospitals into research-ready datasets and software for drug developers and AI teams. Its multimodal platform combines structured records, clinical notes, medical images, and raw biological signals such as ECG waveforms across roughly 15 million patients, helping pharmaceutical companies design smarter trials, discover biomarkers, generate real-world evidence, and validate healthcare algorithms against diverse populations.
Embleema
Embleema is a New York- and France-based healthcare technology company that builds a unified real-world data and evidence platform for clinical research. It aggregates clinical, genomic, and patient-reported data from electronic medical records, wearables, biospecimens, and patient apps into regulatory-grade datasets, and uses no-code protocol tools plus dynamic consent to help pharmaceutical sponsors, research sites, and patient groups run non-interventional and Phase IV studies faster and at lower cost. Founded in 2017 by Robert Chu, the company started with a patient-driven health blockchain and its analytics stack has been used by the FDA for genomic regulatory review.
IgniteData
IgniteData is a healthtech company automating the transfer of clinical trial data between hospital electronic health records (EHRs) and sponsors' electronic data capture (EDC) systems. Its flagship platform, Archer, is a cloud-based, system-agnostic 'Virtual Research Assistant' that uses HL7 FHIR and SMART on FHIR APIs to move clinically validated data securely and automatically, cutting manual transcription, reducing source data verification, and helping treatments reach patients faster. Founded in the UK and now operating on both sides of the Atlantic, IgniteData works with pharmaceutical sponsors like AstraZeneca and research hospitals including UCLH, Cambridge University Hospitals, and Memorial Sloan Kettering Cancer Center.
Robert Chu
Robert Chu is the co-founder and CEO of Embleema, a New York-based clinical research platform that collects and generates regulatory-grade evidence to accelerate precision medicine. He founded the company in 2017 after nearly three decades in enterprise technology and life sciences data, including roles as Senior Vice President of Global Technology Solutions at IQVIA (formerly QuintilesIMS), where he ran a 1,400-person, $800M SaaS business, and prior leadership positions at IMS Health in France, China, and Asia Pacific, following 15+ years at IBM. Trained as an engineer at Ecole Polytechnique in Paris, he now works at the intersection of patient consent, blockchain, and clinical data collection, with Embleema partnering with pharma sponsors and the FDA on real-world evidence workflows.