Pinnacle 21

Since then, Pinnacle 21 has broadened its capabilities and evolved into the industry leader in software and services for managing CDISC compliance, clinical data quality, and FDA submission readiness. In addition to the open source and commercial software products, Pinnacle 21's team of experts support the industry in a variety of ways: submission reviews, creation of Define.xml and SDRGs, CDISC consulting, CRO oversight, and more. They also provide free educational webinars throughout the year, and have even taken to the road with "OpenCDISC Live" events - gatherings where users can meet Max and the Pinnacle 21 staff face-to-face, ask questions, collaborate, and learn. In short, Pinnacle 21 provides the solutions, knowledge, and experience required to give you the best possible chance of achieving FDA approval. "This, really, is just the beginning," says Max. "The standards will keep changing, and it might be another decade before we're all speaking the same language. We understand the importance of our mission to help pharmaceutical companies, CROs, and regulatory agencies exchange data in standardized formats, no matter what challenges the industry will have to face in the months and years to come." Clinical Data Interchange Standards Consortium, Inc. is not associated with and does not sponsor or endorse Pinnacle 21 LLC or its products or services.