Regulatory Expertise

ICON Medical Imaging works directly with FDA, Division of Medical Imaging and Hematology Products and the FDA Therapeutic Divisions such as Oncology, CNS, Rheumatology and Cardiovascular, for medical imaging endpoints.

In addition, ICON Medical Imaging senior management is actively participating in the development of industry standards working with the MCC, PhRMA, FDA, DIA, and the Imaging Core Labs to create standards for charters and submissions. Our clients can expect expert, timely information with regard to current thinking at FDA and regulatory authorities around the world.

ICON Medical Imaging was audited by FDA in  February 2011, June 2009, October 2008 and August 2002. No 483s or other findings were issued. FDA audits involving imaging are complex due to the amount of data that is captured throughout the trial.  ICON Medical Imaging’s proven processes and procedures ensure that this process will be as seamless as possible for all involved parties involved in the audit process. 

ICON Medical Imaging monitors and continually updates our processes with current industry practices and assessment criterias including:

  • SWOG
  • Volumetric CT
  • PCWG2