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
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Consulting and recommendations for clinical trial protocols
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Development and consultation on image acquisition protocols (IAPs), image evaluation protocols (IEPs), and case report forms (CRFs)
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Provide access to subspecialized radiology and image analysis experts for independent centralize image review in multi-institutional clinical trials
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Conduct advanced image processing and analysis and high-quality image interpretation that adheres to the IEPs
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Blinded independent review and adjudication services
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Complete CRFs and answer industry sponsor and CRO queries and concerns
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Maintain an open line of communication with the CRO and industry sponsor
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Establish and maintain quality control and standard operating procedures for all aspects of image interpretation in clinical trials
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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:
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Roles and responsibilities
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Rules for SOP development, approval and distribution
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Consultant and reviewer training and documentation of expertise
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Communications management
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Record retention policy
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Medical image receipt and management
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Image analysis process
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Image review by radiologist
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Image review by a non-radiologist
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Transfer of data to CRO or sponsor
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Study specific operations, review and management
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External query resolution process
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Internal query resolution process
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PI review
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File and image storage
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SOP deviation
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Physical and logical security
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FDA audit
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Non-FDA audit
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Quality Assurance (QA) process
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Quality Control (QC) process
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Study startup
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Study closeout
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Continuing education and training
Areas of Expertise
Oncologic 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.
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:
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Tumor imaging (e.g. FDG PET CT or PET MRI, FLT PET, octreotide, gallium, bone scans, etc.)
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Neurologic imaging (e.g. tumors, dementia, epilepsy)
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Cardiac imaging (e.g. perfusion imaging, stress tests) endocrine (e.g. thyroid)
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Physiologic imaging (e.g. renal function)
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A wide variety of other conditions.