Imaging Endpoints’ 95% Regulatory Approval Rate Leads Industry
Company’s Vast Oncology Experience Leads Industry in Marketing Authorizations
Scottsdale, Arizona, April 25, 2023, Imaging Endpoints (IE) announced today that it has achieved a remarkable 95% regulatory approval rate in over one-hundred marketing authorizations and associated inspections by regulatory agencies for the clinical trials it has supported. IE’s unique approach, “Connecting Imaging to the Cure™,” involves customizing image acquisition and analysis to each trial’s specific needs, yielding unprecedented success with regulatory agencies representing over 40 countries worldwide.
Imaging Endpoints is dedicated to leveraging its advanced imaging science and services to assist its clients in bringing curative technologies to humankind. The Company’s experience spans over 500 oncology trials, and all inspections by regulatory agencies have resulted in zero observations. By optimizing each trial to maximize the opportunity to demonstrate efficacy, as described below, IE has supported many of the most impactful new drug approvals in oncology.
- Customized Imaging Trial Design: IE tailors imaging science to the specific experimental agent, disease type, and objectives of each unique trial. This includes evaluation of the criterion(s) to be deployed and integration of study-specific clarifications and/or modifications that optimize image analysis. Our Scientific and Regulatory experts work in concert with sponsors to define these criteria customizations for each trial.
- Advanced Imaging and Data Analytics: IE offers advanced imaging to help support the endpoints of each trial.
- IE adds imaging acquisition technologies, such as unique acquisition parameters and imaging agents (i.e., CD8 imaging) to help support each study’s endpoints.
- IE specializes in data analytics that provide supportive data from standard-of-care imaging, such as Tumor Growth Kinetics and Radiomics/AI, where over 50 publications have established IE as the industry leader.
The result is that 95% of the trials IE has supported achieved their market authorization goals, demonstrating that Imaging Endpoints’ unique approach leads the industry.
About Imaging Endpoints
Imaging Endpoints (IE) is passionately dedicated to its vision to “Connect Imaging to the Cure” and works every day to advance imaging science, technology, and services aimed at bringing curative technologies to humankind.
Imaging Endpoints is one of the largest imaging CROs (iCRO) globally and the largest oncology-focused iCRO, with 8 offices strategically located across 6 countries including Scottsdale, AZ, Cambridge, MA; London, UK; Leiden, Netherlands; Basel, Switzerland; Hyderabad, India; and Shanghai, China.
- We leverage our teams across the globe to seamlessly train sites and receive, QC, and read scans in real time from thousands of imaging sites in virtually every clinical trial participating country.
- IE’s Team includes world-class leaders in imaging science and regulatory affairs. IE’s experience includes over 500 oncology trials, representing virtually every disease type, analysis criterion, and many of the most impactful new drug approvals in oncology.
- All inspections have resulted in zero observations from regulatory agencies globally.
- IE has experienced nearly 15 consecutive years of high growth with no ownership or executive leadership change, and exceptionally low annual turnover of staff and physician readers.
IE is an affiliate of HonorHealth, one of the largest healthcare systems nationally, and also an affiliate of Southwest Medical Imaging, Ltd. (SMIL/RadPartners), part of the largest private radiology group in the U.S
For further media queries, please contact: Ms Amy Zastawney
Email: azastawney@imagingendpoints.com
No. + 480.914.0006, + 617.697.7175
