A sponsor approached CRMG with a first-in-class diabetes drug that was initially denied approval by the FDA. The FDA required a large safety study be performed, given concerns over cardiovascular risks for the product. read more >
Based on our reputation for quality and attention to detail, a biotech organization approached CRMG to provide rescue trial master file (TMF) support for a large, global Phase III study. Upon an audit of the TMF at the sponsor’s... read more >
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Integrity, Quality, Knowledge, and Passion—the cornerstones of success in life are the core of our business. Our mission is to deliver these key elements to each of our sponsors regardless of size, without exception."
- Stephen Cincotta
President & CEO