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 Corelab-in-a-Box^TM using FTP, HTTPS, etc.

Blinded Reads

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 Corelab-in-a-Box^TM 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 Corelab-in-a-Box^TM for future use.

FDA Access for Review

FDA requests to see images during the submission process. The requested images are pulled from the Corelab-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.

External Collaboration

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 Corelab-in-a-Box repository and available for comparison with earlier reads.

Data Access

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.