aiCRO

Your AI Contract Research Organization

Leverage Arterys experience in performing clinical assessments/trials and achieving regulatory clearance

Design your study. Assemble all documents. Submit.

 

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Scientific Rigor Toward Cloud Collaboration Network

Working towards a rigorous, secure and unbiased assessment

Both the raw data (e.g., DICOM images) and ground truth data (e.g., clinical reports, EMR data, annotations in the Arterys viewer) can be shared across users and back to the producer to make model assessment smooth and collaborative. Thanks to our cloud viewer and annotation tool, multiple annotators can work independently or cooperate, without moving the data from the Arterys platform. In addition, Arterys network provides boundless access to medical data. With immediate access to over 1 Billion images to improve your products and therapies


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Clinical Trials and Assessments

Design the most appropriate study with Arteys support

Arterys can run medical imaging based clinical trials/assessments/studies. The scope of work can be customized per project and could include protocol design and/or statistical analysis. This service can range from:

  • Low-touch: Arterys provides basic viewer access to radiologists employed by a 3rd party

  • High-touch: Arterys designs the trial from scratch, employs its network of radiologists to perform distributed reads, and creates summary reports

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Medical Device Regulatory Submissions

Streamline regulatory clearance with Arterys support

Arterys can support in generating material for a regulator  pre-submission, submission and additional information requests (e.g., FDA, MDR, MDD or CE marking). Arterys can be provided support with all the Technical File documents and write the regulatory submission documents (e.g., 510(k)). This includes providing the submission strategy advice and statistics or act purely in a regulatory strategy role

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Want to learn more? Schedule a meeting with a member of our strategic partnerships team