SMART Submit

SMART Submit is a clinical research image processing tool from Clario designed to collect, store, and share de-identified DICOM images for use in clinical trials. It is intended for research sites, sponsors, and core labs that need to manage medical imaging data in compliance with 21 CFR Part 11 and EU GDPR standards, while reducing compliance risk and protecting patient privacy.

A key problem SMART Submit addresses is the high query rate associated with unscreened DICOM submissions. Without a pre-submission screening system, approximately 20% of queries may need to be reopened, and in some hospitals this rate reaches 80%. These queries consume time and research funding. SMART Submit applies pre-submission image screening using AI technology with custom, trial-specific acceptance criteria to reduce this burden.

De-Identification and Compliance

• Uses over 150 rules to detect and rectify common issues in DICOM files, including the presence of visible patient health information (PHI).
• Applies a proprietary automated de-identification system with three levels of verification.
• Described as 48-fold more proficient at removing PHI than other DICOM transport solutions.
• Supports compliance with 21 CFR Part 11 and EU GDPR standards.

Image Quality Control

• Clinical research imaging experts perform quality control (QC) for anomalous cases or studies generated by new imaging equipment.
• The QC team can query sites directly to resolve image issues.
• Files can be screened against sponsor-specified acceptance criteria as part of the QC process.

Workflow and How It Works

1. The research site loads the original DICOM file into the software application and enters the case trial identifiers.
2. SMART Submit handles de-identification and verification automatically.
3. Images can be uploaded from anywhere in the world via a 100% browser-based interface — no additional hardware or software installation is required.
4. Once de-identified, images are made accessible to sponsors or authorized users online, and can be sent automatically to one or more recipients, downloaded on demand, or stored in an online Image Repository.

Key Capabilities

• Browser-based access through a Global Cloud Network, requiring no local installation.
• Supports multi-recipient image distribution and on-demand download.
• Online Image Repository for storing processed images.
• Pre-submission AI screening with trial-specific acceptance criteria to reduce query rates and associated costs.

SMART Submit is delivered as a cloud-based platform, accessible via a secure portal login. It is positioned for use by clinical trial sites and sponsors managing medical imaging workflows where PHI protection, regulatory compliance, and image quality assurance are required.