Radiant Sage's solutions have innumerable uses which result in substantial quantiable benefits to the various players in the clinical trial eco system. To demonstrate some of the potential uses of the Radiant Sage products, a few real-life case study examples have been produced here:
Data Standardization and Acquisition
A clinical trial is being conducted for a new drug. An imaging CRO is contracted to oversee the process. They receive images from multiple sites. Some images are sent via FTP, others are sent on electronic media by mail, while yet others are sent on film by courier. Some of the electronic data is in DICOM, others are in vendor proprietary formats.
On receiving the image data the imaging CRO:
- Scans the films into a digital format
- Converts the proprietary formats to DICOM
- Adds any essential meta data that is not already with the image data
- Performs image QA/QC
- Loads the data into Core-Lab-in-a-BoxTM using FTP, HTTPS, etc.
After the collection of study data is finished the CRO pulls the images from the repository. A semi-automated software tool is used to segment a region of interest on the images. The segmentation bit map is stored back into the system. The data is blinded and randomized for the read. Multiple radiologists are recruited to interpret the segmentation results and they are allowed to make adjustments to the computer generated bitmap. The data is read multiple times with each radiologist blinded to the findings of the other radiologists. Results are stored back into Core-Lab-in-a-BoxTM and final reports are generated.
Image Retrieval using Meta Data
A researcher has developed a new algorithm for segmenting brain tissue. The researcher wants to search the repository for brain scans with particular acquisition parameters. In particular he is interested in scans that have been previously segmented. After selecting appropriate datasets the algorithm is run on the data and the results are compared to the previously acquired results. Segmented results are written back to the repository in Core-Lab-in-a-BoxTM for future use.
FDA Access for Review
FDA requests to see images during the submission process. The requested images are pulled from the Core-Lab-in-a-Box repository for FDA review. Alternatively, this tool may provide the opportunity for the NDA to contain hyperlinks to images in the repository. The reviewer will have ready access to the original and processed data supporting our application.
An additional read is needed for evaluating the study data. A set of images needs to be made available for an offsite radiologist to conduct a blinded review. The results are stored in the Core-Lab-in-a-Box repository and available for comparison with earlier reads.
A particular study is being conducted out of a sponsor central facility. The project team needs to have quick access to the image data in order to monitor the study. A mirror copy of the study is locally available for retrieval.
Data Storage and Migration
In the event of an acquisition, divestiture or in-licensing agreement, it is imperative that both legacy and new image data can be stored & migrated effectively and accessed globally.