Imaging

ICON Medical Imaging provides medical imaging based product development services that expedite drug development.

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 August 2002 and October 2008. No 483s or other findings were issued. The most recent audit involved four projects for one client. The projects were conducted over a three year period and both hard copy and electronic data had to be recalled for the audit. This was both a process and data audit, including review of the eCRF and image systems used. No findings were identified and no 483s were issued during either of these audits.

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

  • RECIST 1.0 and RECIST 1.1
  • Cheson (1999 and 2007)
  • WHO
  • MacDonald
  • SWOG
  • EORTC
  • Volumetric CT
  • PCWG2

ICON Medical Imaging is ISO 9001:2000 certified.  ISO 9001:2000 certification is rarely seen among Medical Imaging Core Laboratories. Our ISO 9001:2000 certification recognises ICON Medical Imaging's ongoing commitment to quality, reliability and continual improvement of all processes while maintaining transparency for better customer satisfaction.