WCC surveys investigator sites to confirm their hardware is technically adequate and complies with the imaging acquisition protocol. Using WorldPRO®, WCC will test image quality before the study begins using a phantom or test scan, which is submitted and reviewed by a trained imaging technologist or a leading radiologist. With this test conducted and the scan quality confirmed, the site is now ready to participate in the image submission process.
The submission process is quick and efficient. The project manager has the ability to perform screening and eligibility reads quickly with instantaneous site notification.
Following the QC process, sponsors have the ability to review all data to confirm the accuracy of case records and select which subjects are ready for review. As assessment progresses, all data is accessible by the sponsor in a read-only format, which is important for data integrity, and is archived for regulatory review.
Edit checks are performed during image upload and presented for resolution at the time of transmission. This helps to minimize the cost of issuing queries and reduces delays during the read process.
Submissions are immediately available for viewing in full resolution or as thumbnails. WCC's CRAs can manually check and remove sensitive headers and assess image quality and completeness.
Outstanding issues in the QC process are handled within WorldPRO® where queries can be issued to sites with an email notification providing escalation support. All responses are logged and maintained throughout the trial.
If you are coming from another system or vendor, data transfers in WorldPRO® are integrated into a single case record for EAC review. Data can be imported in ASCII, XML, or PDF formats natively and further capability can be delivered upon request.