fda
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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.
PointCross Life Sciences
PointCross Life Sciences is a Foster City, California software and services company that turns the messy data of drug development into FDA-ready submissions. Through its XBIOM platform and eDataValidator, it standardizes nonclinical and clinical study data to CDISC SEND, SDTM and ADaM formats, runs a Hadoop-based data repository for sponsors, and supplies the U.S. FDA itself with the software reviewers use to read nonclinical submissions. The company quietly powers roughly a quarter of all FDA SEND submissions.
Auxilius Pharma
Auxilius Pharma is a clinical-stage cardiovascular pharmaceutical company developing AUX-001, a once-daily extended-release formulation of nicorandil for the roughly 11 million Americans living with chronic stable angina. By reformulating an established molecule through the FDA's 505(b)(2) pathway, the company aims to deliver what would be the first new innovative oral angina therapy in the US since 2006 - improving adherence, tolerability and outcomes for patients who still suffer symptoms despite optimal treatment.