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Tagged: drug-safety
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Health · Saas · Ai
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.
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Executive · Founder · Author
John Balian
John D. Balian, MD is a physician-turned-executive who co-founded ClinChoice, one of the world's larger full-service contract research organizations, and serves as its CEO, International. He spent years inside the FDA, then ran drug safety and regulatory operations at Pfizer, Bristol-Myers Squibb and Johnson & Johnson before building a global CRO spanning the US, Europe and Southeast Asia. He is also a published novelist whose debut, Gray Wolves and White Doves, draws on his Armenian heritage and the Armenian Genocide.
clinchoice · croRead →