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Services

Independent Radiology Review

Through a network of clinical and research experts in medical imaging, we offer subspecialized consulting and image interpretation for artificial intelligence companies and clinical research organizations (CROs) conducting phase 1, 2, 3, or 4 clinical trials that involve imaging endpoints.

AI Algorithm Development

Using state-of-the-art technology, we offer rapid, high-quality 2D and 3D medical image segmentation and annotation services for industry partners interested in machine learning, deep learning,and AI algorithm development.

AI Algorithm Validation

We also serve as an imaging CRO for startups and established industries seeking to validate their AI algorithms through clinical trials and multi-reader studies. Our network of academic radiologists are experienced in AI algorithm development, validation, and regulatory clearance.

Standard Operating Procedures

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

Standards & Processes

  • Establish rules for SOP development, approval and distribution

  • Manage SOP deviation

  • Develop image acquisition protocols (IAPs)

  • Develop image evaluation protocols (IEPs)

  • Establish an image analysis process

  • Establish study-specific operations, review and management

  • Establish quality assurance (QA)  & quality control (QC) processes

  • Establish roles and responsibilities

Documentation & Storage

  • Document consultant and reviewer training and expertise

  • Establish a record retention policy

  • Manage medical image receipt and storage

  • Develop case report forms (CRFs)

  • Transfer of data to CRO or sponsor

  • Maintain file and image storage

  • Maintain physical and logical security

Management & Coordination

  • Communications management

  • Coordinate image review by a radiologist

  • Coordinate independent review by blinded radiologists

  • Coordinate image review by a non-radiologist

  • Maintain continuing education and training

  • Participate in FDA audit

  • Manage non-FDA audit

  • Coordinate study closeout

  • Complete external query resolution process

  • Conduct PI review

  • Transparent study startup

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