Continues Record of Inspection Excellence
Scottsdale, Arizona – Imaging Endpoints (IE) announced today that it concluded another FDA BIMO inspection at its corporate offices last week with no observations. The inspection was for the Company’s work on an extraordinarily complex registration trial for an 18F-based PSMA-targeted PET imaging agent that enables visualization of primary tumors as well as bone and soft tissue metastases. This result continues the Company’s perfect record for regulatory inspections and re-emphasizes its growing leadership in contributing to new drug approvals.
Imaging Endpoints has designed and built an industry-leading Quality Management System under the leadership of Manny Ramirez, IE’s Chief Compliance and Regulatory Affairs Officer. Imaging Endpoints’ Compliance and Regulatory team, as well as its Operations, Scientific Affairs, Data Management and Information Technology teams are to be commended on the excellence they have consistently achieved through consecutive FDA BIMO inspections with no observations, as well as supporting numerous sponsor and site inspections by FDA, EMA and PMDA that have also resulted in no observations or findings related to the Company’s imaging services.
“Ultimately, this is why we do what we do at Imaging Endpoints – we strive to optimize trial design and perform compliant independent imaging review to help bring lifesaving technologies to fruition,” said Doug Burkett, Ph.D., Chief Executive Officer and President. “Prostate cancer is the 3rd most prevalent cancer type globally and typically the 2nd leading cause of cancer deaths among men. Our contribution to this imaging agent’s development and our successful FDA inspection bring this technology for earlier / improved detection of prostate cancer one step closer to potentially helping humanity.
For more information on the Imaging Endpoints, visit https://imagingendpoints.com.
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 experience spans hundreds of successful trials across all phases of development, including many of the most high-profile, global registration trials in the industry. IE also accelerates product development by integrating new, more powerful 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, AZ, with offices in Waltham, MA, and Hyderabad, India as well as new offices opening soon in Basel, Switzerland; Amsterdam, the Netherlands and Shanghai, China. 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.