Imaging Endpoints Successfully Completes FDA Inspection
Imaging Endpoints (IE) is proud to announce the successful completion of a Bioresearch Monitoring (BIMO) inspection by the U.S. Food and Drug Administration (FDA) at its corporate office in Scottsdale, Ariz., June 7, 2018. The inspection concluded with perfect results; no Form 483 issued and zero observations – clearly demonstrating Imaging Endpoints’ excellence in GCP compliance and quality research.
The BIMO inspection lasted four days and focused on IE’s quality management system, data integrity and clinical imaging results in support of an NDA submission. For the Sponsor study under review, Imaging Endpoints provides comprehensive imaging CRO services including site training and qualification, real-time image receipt, QC, query management and archival, reads using only board-certified radiologists and medical oncologists, real-time reader monitoring and QC of reads, as well as data exports in a CDISC compatible format.
The inspection was hosted by Imaging Endpoints’ executives and the study’s project team, led by Manuel Ramirez, RAC, Senior Vice President, Compliance & Regulatory Affairs. Under his leadership and direction, Imaging Endpoints continues to develop and maintain an industry-leading level of GCP compliance in imaging Quality Management Systems (iQMS). Ramirez commented: “We have set high quality standards and are pleased with the success of our iQMS implementation over the past several years. The positive inspection outcome provides confidence to Sponsors in the reliability of our results, the robustness of our iQMS, and our commitment to providing the highest regulatory and quality services in the imaging industry.”
Ron Korn, MD, PhD., Chief Medical Officer and Founder of Imaging Endpoints commented: “Imaging Endpoints has become recognized as the leader in radiology science, technology and customized services, and has now proven its leadership in quality and compliance. This is a milestone achievement toward our vision to change the way imaging is used in clinical trials and connect imaging to the cure.”
Doug Dean Burkett, PhD., Chief Executive Officer and President of Imaging Endpoints added: “We are very pleased with the outcome of our FDA inspection and proud of the excellent quality services that our project teams and management provide. The success of our inspection is the result of the excellence of our iQMS, the cross-functional discipline of our project teams, and our emphasis on exceeding all regulatory requirements and Sponsor needs.”
Imaging Endpoint’s inspection success is a testament to its significant investment and ongoing focus on combining superior radiology science with leading compliance and a passion for delivering quality results. IE remains committed to meeting and exceeding imaging standards and the expectations of regulators as the dynamics of imaging GCPs continue to evolve.
About Imaging Endpoints:
Imaging Endpoints (IE) is an imaging research and core laboratory that provides comprehensive imaging CRO (iCRO) services throughout the clinical trial process. IE is recognized as the preeminent iCRO for complex trials and offers all imaging aspects of trial planning and administration, including protocol development, site instrumentation standardization, real-time image collection and quality control, standardized and real-time central reads, imaging data management and final reporting for regulatory submission.
In addition to its core services, IE accelerates product development by integrating new, more powerful imaging technologies into clinical trials such as macrophage imaging, pseudo-progression analysis, radiomics and artificial intelligence where peer-reviewed publications have established the company as the industry leader.
IE’s imaging CRO experience spans hundreds of successful trials across all phases of development, including some of the industry’s most complex and high-profile registration trials. The company provides global services and seamlessly trains sites and receives/reads scans in real time from hundreds of imaging sites in over twenty countries.
Imaging Endpoints is based in Scottsdale, Ariz., serving the U.S. West Coast and the Pacific Rim. IE’s East Coast office in Waltham, Mass., serves the Boston biotechnology sector, the U.S. East Coast and Europe. IE is an affiliate of HonorHealth, home to the Virginia G. Piper Cancer Center, one of the largest healthcare systems nationally. IE is also an affiliate of Scottsdale Medical Imaging, Ltd. (SMIL/SDI), ranked as the fourth-largest private radiology group in the U.S., home to IE’s 40 in-house radiologists.
For more information, contact Caroline DeStefano at cdestefano@imagingendpoints.com or 480.314.3070.
