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.
-1.png "8 (1668 × 478 px)-1")
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
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
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
