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Medical Imaging

Medical imaging in clinical trials

Cardinal Systems Medical Imaging can manage all aspects of the imaging component of your clinical trial, from protocol consultation and development to independent expert blinded review and image archival.

Imaging workflow

Imaging protocol design Multi-site imaging coordination Image management Central blinded review Query management Databases and reporting systems
Modality section Site training and certification Image retrieval and DICOM image conversion Independant review charter writing Real time imaging project reporting Secured image storage
Imaging parameters standardisation Study specific supplies DICOM file editing demographic anonymisation Selection, training, validation and monitoring of readers Pro-active query resolution 21 CFR part 11 platform
Review criteria evaluation Expert project management Quality assurance and pre-processing eCRF / Leading edge reading workstation    

Expertise in methodology

Cardinal Systems is recognised for its expertise in methodology and its knowledge in innovative designs. This strength gives Cardinal Systems Medical Imaging a real advantage in reading protocol development in different therapeutic areas.

Therapeutic areas

With a large network of experts in various therapeutic areas, Cardinal Systems Medical Imaging can support appropriate surrogate endpoints and provide streamlined workflow for blinded reading.

Areas of therapeutic expertise include :

  • Oncology
  • Cardiology
  • Neurology
  • Rheumatology
  • Dermatology

Modalities

Cardinal Systems Medical Imaging  has significant experience with a wide range of imaging modalities including :

  • MRI
  • CT
  • PET
  • X-Ray
  • Ultrasound
  • Angiography
  • Digital photography

 

Support

Cardinal Systems Medical Imaging solution benefits from a  proprietary platform, InfoGate®, which can be easily integrated into external systems and innovative algorithms to enhance image transfer and consistent information workflow. It allows central data storage and real-time review for tracking and reporting.Cardinal Systems’ technology platform is 21CFR Part 11 compliant, with 24/7 online support.

Expert Project Management

Cardinal Systems Medical Imaging Team, located in Europe and North America, is specialised in imaging management within clinical trials. Working closely with our partners to ensure FDA compliant imaging solutions, we aim at delivering the best software environment for image assessment.

Examples of reading endpoints

Neurology Dermatology Oncology

Using Functional Diffusion Mapping we can monitor the early impact of anti-cancer drugs and radiation therapy • 2D and 3D ROI measurements • Diffusion and perfusion • Region activation using fMRI • Volume measurements

We ensure accurate and reproducible comparison over time of a lesion’s digital photograph by using colour calibration validated algorithm.

We provide a complete  set of tools for response assessment in a multi-modality environment: RECIST/ WHO response rate, volumetric analysis, PET/CT image fusion, SUV  calculation
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InfoGate for Imaging

IG Client

Cardinal Systems Medical Imaging solution benefits from a  proprietary platform, InfoGate, which can be easily integrated into external systems and innovative algorithms to enhance image transfer and consistent information workflow. It allows central data storage and real-time review for tracking and reporting. Cardinal Systems' technology platform is 21CFR Part 11 compliant, with 24/7 online support.

Critical Path 2004

Aligned with the FDA's Critical Path Initiative on Imaging in clinical trials, Cardinal Systems provides flexible and cost-effective solutions for evaluating the safety and efficacy of new therapies, so accelerating their development to the pharmaceutical market.

 

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