Embleema's software platform brings precision medicine sooner to patients by collecting and generating regulatory-grade evidence. Our platform natively unifies clinical, molecular and real-world data and is the sole one used by the FDA for its regulatory evaluation of health products involving genomic datasets. The protocols and algorithms contained in our platform are also the basis for future CDISC standards for cell and gene therapies. The FDA also uses our platform to produce regulatory grade genomic sequences for SARS-CoV-2 and other microbial pathogens (project ARGOS). In addition to the FDA, our platform powers the Lupus Landmark Study, the largest clinical study for lupus in the world, the Human Epilepsy Projects and tens of other clinical studies for pharmaceutical companies, biotechs and patient groups. More than half of the top 10 Investigational sites in the US use our platform: John Hopkins, NYU, UCSF, Yale, UPenn, Washington University in St Louis, Cornell and many others also such as Mayo Clinic, Yale, Georgetown.