Bringing any new drug to the market takes years, hundreds of millions (to billions) of dollars in research and there's a risk at every development phase that the drug fails to meet the objectives, either due to a bad study design, difficulty to find patients to be enrolled, issues with how the data points are analyzed or inappropriate efficacy metrics/trial endpoints. This is a problem for patients who need the therapies and for pharma developing drugs, because enabling the right decisions is healthcare is expensive and time consuming. In this talk we will show a few examples of how regulatory-grade AI biomarers are redefining the industry standards to enable the right decision sooner via improved management and oversight of clinical studies and real time monitoring and analysis of data.