Medical Imaging Solutions & Biomarkers

The use of medical imaging as a component of clinical trials enables improved decision making, increased efficiency, and can reduce trial costs in the long run.  To maximise on results, clients need to work with an imaging partner that who provide strategic advice on biomarkers in early phase development and demonstrate how medical imaging endpoints can provide objective evidence of a drug’s safety and efficacy. 

Bringing you the best of both worlds

Working with ICON offers you the advantages of an industry leading specialist provider combined with the benefits of a global CRO. We are dedicated to the success of your imaging endpoints and provide advice on the critical uses of imaging in your trials, including the medical, scientific and regulatory aspects.

Industry leading experts

With over 20 years of experience, our medical imaging team is the most experienced team in the industry. Our breadth of experience and expertise across phases, therapeutic areas and indications will bring real value to your clinical development programme.  

Expert Analysis
ICON engages the best doctors from several of the top rated hospitals. They have experience in all analysis criteria. This combined with our proven best practices, and access to our industry-leading MIRA technology, ensures data quality, accuracy, and accelerated clinical trial management. 

We will work with you to select the right readers for your trial according to your study, budget, and timelines.  All reviews are performed through our MIRA and linked to a protocol-specific eCRF. Readers can access this information at any time, from anywhere around the globe to perform reads of all types.

Regulatory Insight
Our senior experts work directly with the FDA, division of Medical Imaging and Hematology Products and therapeutic divisions for medical imaging endpoints. They also actively participate 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 timely information with current thinking at FDA and regulatory authorities around the world.

Integrated Medical Imaging solutions

Our highly trained project management professionals have oversight across all services and studies. They will ensure that you benefit from a fully integrated approach.

Comprehensive services range from standalone to full service solutions including;

  • Assessing clinical trial endpoints for Phase I–IV trials
  • Imaging for efficacy and safety: primary and secondary exploratory endpoints
  • Support for early phase decision making
  • Statistical support for validation of novel scales and method

Therapeutic Expertise

We focus on the success of your imaging endpoints and provide consulting on the critical uses of imaging in your trials taking into account the medical, scientific and regulatory aspects. We have strong experience in the following areas

ICON are experts in the complex world of clinical trial oncology response criteria implementation. Our experts work with you to review the criteria and how they might work in a clinical trial using sound medical and statistical practices.  We can also show you the operating characteristics of every option. From early phase decision endpoints that have power far beyond standard criteria to unambiguous interpretation options of complex criteria. 

Indications include:   Breast, Colorectal, Gastric, Globastoma, Glioma, Head and Neck, Lung, Lymphoma, Melanoma, Ovarian Prostate, Renal Cell Thyroidosis
Criteria include: RECIST, mRECIST, Choi, RANO, Cheson, Lugano Classification, Halleck, McDonald (for MS), iIRECIST, RECIL, iRANO/bmRANO/pedRANO, PCWG, PCWG3, Loes Score (for adrenoleukodystrophy), RAMRIS

Find out more about our Oncology services

Other areas where we have deep therapeutic understanding and experience are:
Cardiovascular, Neurology/CNS, Gastrointestinal and Musculoskeletal.

You will have access to the NASH CRN Radiologist and other KOLs in the field to benefit from experience in qualification of sites globally.  Find out how ICON helped a pharma client to escalate timelines in a NASH clinical trial by downloading the case study

Applied innovation

We offer flexible, leading technology solutions for collecting, managing, and processing image data.  Our imaging experts have expanded tumour volumetric expertise, and automated tools that allow you to manipulate ROIs. Our leading technology platforms include Medidata's cloud based medical imaging, MIRA™, SQUARE™, and PIER™.  These enable us to offer you;

  • Flexible and time sensitive review processes
  • Practical solutions for rapid data review
  • Adherence to study timelines
  • Global accessibility
  • Secure on-site and off-site data review systems

When working with us, you will also have access to our full technology portfolio including FIRECREST, leading digital solutions for clinical trials.  FIRECREST is designed to improve site performance and can faciliate training of site staff and independent reviewers. 

Experience you can trust

  • 200 certified physicians, scientists, and technologists
  • 700+ trials in the last 5 years
  • 25 FDA approvals delivered