RSV has web-based zero foot print import module referred to as RadGate that sites use to upload data into the system. Site users (or anyone with site-specific upload access) log in and select a patient or timepoint to upload. The user selects a folder or files to upload, and the upload module processes these files and presents the user with a summary manifest of what will be uploaded, excluding data that is extraneous (e.g., ".exe" files). This form can be configured to ask for additional data if necessary (not in the headers). A viewer is also available that can be used to view the images prior to transmittal (this step can be a requirement or optional). The user is presented with a Data Transmittal Form (DTF), signs the DTF, and the transfer of images starts.

As the images are transferred, they are blinded and anonymized based on study configurations. RadGate also checks for duplicates, "bad" DICOM files, etc., runs edit checks to check for data issues (e.g., wrong modality, incorrect acquisition parameters if configured, etc.), and can automatically create Data Clarification Forms (DCFs) or Protocol Deviations (PDs) that have to be addressed by the site/corelab staff. Once all the images are uploaded, a copy of the DTF is sent to the site for their records, and the uploaded content is added to the study’s workflow (Eligibility, QC, etc.) with automated notification to users that new data has arrived and needs to be processed. The module also has features to import non-DICOM data and hardcopy film, along with a myriad of other features.

Blinded Reads Post-QC, RadFlow provides an unsupervised workflow engine to assign image datasets to be assessed by various trained radiologists in this trial. When a task is started, RadVista loads the appropriate datasets and analyzes modules that are configured and potentially customized to the needs of the reading paradigm. RadVista offers a semi-automated tool to segment a region of interest on the images with a single click to reduce reader time and effort.

RadVista covers most of the oncological assessment criteria (e.g., RECIST, mRECIST, etc.). RadVista also has many analysis tools to address analysis needs for MKS, CNS, cardiovascular, and other therapeutic areas. The results are stored in an electronic Case Report Form (eCRF) that is customizable as needed. The measurements are also stored back on the server with the audit. trails. Image data can be completely blinded and randomized. for reading, if necessary. Multiple radiologists are recruited to perform assessments, which automatically trigger adjudications to happen based on discrepancies between multiple readers. All results are stored back into Corelab-in-a-BoxTM, and final reports are generated. RadFlow and RadVista have been developed in many configurations and options to support the diverse range of requirements for blinded reads

RadVault stores metadata about each and every file in the vault. Searches can be executed against this metadata. Results can be organized into cohorts, and these cohorts can be shared with authorized users for a myriad of purposes. One such purpose is to create, test, and evaluate analysis algorithms.

A researcher searches RadVault for brain scans with particular acquisition parameters to test a new algorithm for segmenting brain tissue. The focus is on scans that have been previously segmented and analyzed. The algorithm is run on the data in the cohort, and the results are compared to the previously acquired results. Newly generated results are then written back to RadVault for future use.

Regulatory authorities may request to view images, and the requested images are flagged in Corelab-in-a-Box for real-time review, assessed using a browser.

Alternatively, the tool may provide the opportunity for the submission to contain hyperlinks to images in the repository. Reviewers will have ready access to both the original and processed data.

The project team needs quick access to image data to monitor the study. Authorized users log in to view image data, either as assigned tasks or by manually navigating to the appropriate patient.

Images are rendered in the browser and made available to the user along with additional non-image data, such as measurements, eCRF, or reports, based on permissions.

RadVista's support for Oncological Assessments is unique in that it reduces radiologist time to perform assessments across timepoints through automation. RadVista ensures all lesions are properly tracked temporally, with options to split/merge lesions, assign lesion numbering, etc. RadVista supports all the common criteria, including RECIST, mRECIST, iRECIST, CHOI, LungRads, etc. Each criterion's requirements can be configured as needed.

RadVista supports all the common criteria, including RECIST, mRECIST, iRECIST, CHOI, LungRads, etc. Each criterion's requirements can be configured as needed.

RSV's AI model for anatomical brain assessment processes T1 brain scans and segments over 80 regions of the brain in less than 90 seconds. Volumes of each region are calculated along with total brain volumes to detect changes in volumes across timepoints.

CLIB supports the upload of image files (JPG, PNG) from external sources and links them to subjects in a study. Uploaded images follow a similar process and undergo QC before being made available for assessments. Assessments can be qualitative or quantitative. RSV has also developed a Smartphone App for Android as well as Apple phones, enabling participating subjects to take images at home and automatically upload them to CLIB.

The app supports interactive help to assist subjects during image acquisition. Additionally, the app facilitates image QC and analysis on the phone before upload, improving the quality of acquired images. The App also supports a patient-centric eCRF (e.g., QOL form, etc.) to capture responses directly from patients. RSV is also exploring the use of AI to enhance the patient experience.

RSV offers an Event ADJUCATION platform that combines modules in CLIB to deliver a unique and customizable solution to adjudicate events and support safety committees. RadEvent supports the upload of essential documents, files, and images, along with additional content to create a dossier for each event to be assessed.

Uploaded content is QCed, including features for redaction, translation, merging, splitting, and concatenating of documents as needed. Custom workflows can be set up to process any of the uploaded data. Once dossiers are created, experts can review the dossier and respond to eCRF questions. Assessments can be compared, and further reads can be performed. RadEvent also supports real-time consensus reads with multiple signatures.