Services and Experience

Independent Radiology Review for the 21st Century

IMAGING CORE LAB

Our Services and Expertise

Through a network of national experts and access to state-of-the-art technology, Radiostics offers subspecialized consulting and image interpretation for clinical research organizations (CROs) conducting industry-sponsored trials.

We are leaders in independent radiology review of phases 1 through 4 drug and device trials and work closely with regulatory officials. Our diverse team of independent reviewers are from preeminate academic and clinical practices.

Independent Centralized Reviewers

We collectively offer over a hundred years of experience in the areas of oncologic, musculoskeletal, cardiovascular, and neuroimaging.

Our Services

Consulting and recommendations for clinical trial protocols
Development and consultation on image acquisition protocols (IAPs), image evaluation protocols (IEPs), and case report forms (CRFs)
Provide access to subspecialized radiology and image analysis experts for independent centralize image review in multi-institutional clinical trials
Conduct advanced image processing and analysis and high-quality image interpretation that adheres to the IEPs

Blinded independent review and adjudication services
Complete CRFs and answer industry sponsor and CRO queries and concerns
Maintain an open line of communication with the CRO and industry sponsor
Establish and maintain quality control and standard operating procedures for all aspects of image interpretation in clinical trials
Prepare for and assist with FDA and Non-FDA audits

Quality Control and Operating Procedures

Radiostics offers an extensive quality control process through the following specific standard operating procedures:

Roles and responsibilities
Rules for SOP development, approval and distribution
Consultant and reviewer training and documentation of expertise
Communications management
Record retention policy
Medical image receipt and management

Image analysis process
Image review by radiologist
Image review by a non-radiologist
Transfer of data to CRO or sponsor
Study specific operations, review and management
External query resolution process
Internal query resolution process
PI review
File and image storage

SOP deviation
Physical and logical security
FDA audit
Non-FDA audit
Quality Assurance (QA) process
Quality Control (QC) process
Study startup
Study closeout
Continuing education and training

Chief Quality Control Officer

Haley Hendrix, RT (R) (CT)

Haley has extensive experience with quality, regulatory compliance, and standardized operating procedures in clinical trials with imaging components. She concurrently serves as a research imaging coordinator for the Department of Radiology at the University of Alabama at Birmingham, where she manages quality in clinical trials run through the Human Imaging Shared Facility and Tumor Metrics Lab. Her experience in quality and clinical trials is a major asset to Radiostics. Contact her by email.

Areas of Expertise

Radiostics offers unparalleled expertise for oncologic imaging trials. We provide access to national experts who have significant depth in sub-specialized oncologic imaging experience.

Our oncologic radiologists interpret all imaging modalities, utilize any objective response criteria, and evaluate all tumor types.

We have content expertise in all treatment types, including chemotherapy, target therapy, immunotherapy, radiation therapy, embolic therapy, etc.

Our partnership with AI Metrics technology further sets us apart and is unparalleled in the industry.

AI Mass is the only computer-assisted tumor response evaluation platform shown to reduce errors in a multi-institution setting.

This advanced image processing and workflow tool gathers multiple tumor metrics, automates tumor metric extraction and calculations, provides annotated images of all tumor metrics, and simultaneously performs multiple objective response criteria.

Oncologic Imaging

Musculoskeletal Imaging

Radiostics puts you in contact with experts in musculoskeletal imaging for your drug or device trial. We work with all imaging modalities and all joints, bones, muscles, and ligaments.

We have experience in all body regions and with a wide variety of devices. A thorough understanding of musculoskeletal imaging endpoints allows us to meet the needs of your clinical trial.

Cardiovascular Imaging

Radiostics has extensive experience and in-depth knowledge in cardiovascular device studies. We specialize in aortic stents and peripheral vascular devices and interventions.

Our cardiovascular imaging experts provide consulting, advanced image processing, quantitative metrics and other services to assist with evaluation of your device.

We have collectively seen it all and understand that the success of your device requires accurate and timely quantitative data and expert image analysis.

Neuroimaging

Radiostics connects you with field leaders with content expertise across all major neuroimaging modalities and indications.

We understand the complexities of imaging endpoints required for monitoring specific neurological disease states in phase 1 through 4 clinical trials. You can rely on us for your consulting and both qualitative and quantitative image interpretation needs.

Molecular Imaging

Radiostics has field leaders in molecular imaging who specialize in image interpretation using a wide variety of radiotracers, and they have experience with all imaging modalities, including PET CT, PET MRI, and SPECT.

We understand scintigraphic imaging, radionuclide therapy, and use of radionuclides to ascertain physiology and in vivo tracer kinetic studies. We have expertise in the following:

Tumor imaging (e.g. FDG PET CT or PET MRI, FLT PET, octreotide, gallium, bone scans, etc.)
Neurologic imaging (e.g. tumors, dementia, epilepsy)
Cardiac imaging (e.g. perfusion imaging, stress tests) endocrine (e.g. thyroid)
Physiologic imaging (e.g. renal function)
A wide variety of other conditions.

Miscellaneous Imaging

Radiostics has you covered with experts in a wide variety of miscellaneous imaging techniques.

We have expertise in the following:

High-resolution CT (e.g. emphysema, pulmonary fibrosis)
CT imaging of the body (e.g. chest, abdomen, and pelvis)
CT imaging of liver fibrosis, liver fat quantification by CT or MRI, liver fibrosis assessment by ultrasound or MR elastography
Liver fat and iron quantification by MRI
Body composition / anthropomorphic analysis by CT or MRI