Scottsdale, Arizona, May 27, 2020 – Imaging Endpoints announced today that it has supported two additional U.S. Food and Drug Administration (FDA) approvals this month for new, life-saving therapies. The two New Drug Application (NDA) approvals, for two of the Company’s pharmaceutical company clients, included indications for adult patients with non-small cell lung cancer (NSCLC), adult and pediatric patients with thyroid cancer, and adult patients with advanced gastrointestinal stromal tumors (GIST).
Imaging Endpoints serves as the imaging CRO that performed the blinded independent central review of imaging for these new cancer treatments. The large, global clinical trials that supported these approvals included complex imaging requirements, a double read paradigm with real-time reporting, and included imaging within the primary endpoint.
Imaging Endpoints’ robust processes are designed to meet or exceed industry standards. All inspections to date, including inspections in 2018, 2019 and 2020 by FDA and the European Medicines Agency (EMA), have resulted in zero observations, clearly demonstrating the Company’s leadership in quality and compliance.
Doug Dean Burkett, PhD., Chief Executive Officer and President of Imaging Endpoints added: “We are honored to have supported the FDA approval of these two additional life-saving therapeutics as part of our relentless endeavor to Connect Imaging to the CureTM. Our rapid growth and success is the result of our dedication to provide industry-leading expertise, technologies and services through our amazing global team.”
About Imaging Endpoints:
Imaging Endpoints (IE) is an imaging research and core laboratory that provides comprehensive imaging CRO (iCRO) services and technology solutions throughout the clinical trial process. IE is one of the largest iCROs globally and is widely recognized for conducting the industry’s most complex imaging trials.
IE’s iCRO experience spans hundreds of successful trials across all phases of development, including some of the most high-profile, global registration trials in the industry. In addition to its core services, IE accelerates product development by integrating new, more powerful imaging technologies into clinical trials such as radiomics and artificial intelligence where peer-reviewed publications have established the company as the industry leader.
Imaging Endpoints is based in Scottsdale, Ariz., with an East Coast office in Waltham, Mass. IE is an affiliate of HonorHealth, one of the largest healthcare systems nationally, and an affiliate of Southwest Medical Imaging, Ltd. (SMIL/RadPharm), part of the largest private radiology group in the U.S.