BioREAD Independent Image Review Technology
BioREAD is a custom-designed system, developed by BioClinica which provides full image display capabilities for independent review of clinical trial imaging data. BioREAD captures the reader’s interpretation and image evaluation in one solution, making the review process more efficient and reducing the potential for errors. BioClinica’s integrated imaging core lab systems ensure images are displayed in a completely blinded fashion which eliminates any potential bias associated with the review. BioREAD is built on a deep understanding of the complexities and differences among the three major independent read scenarios:
- Eligibility — using imaging to determine inclusion or exclusion of the patient into your trial.
- Efficacy — using imaging to support your trial’s primary and/or secondary endpoints.
- Safety — using imaging to evaluate your trial’s safety profile.
A reader using BioREAD is presented with an electronic Case Report Form (eCRF) screen and corresponding questions in accordance with the study-specific read protocol. Multiple display monitors are used as needed, and the interface allows the reader to maximize visualization of the images and take measurements when applicable. The type and amount of supplemental information with which the reader is provided is prospectively determined as part of the read protocol which is enforced through a customized workflow. Logic coded within the data imaging application ensures that all required questions are addressed and data checks are performed as the reader enters information to ensure data consistency. Since the data is entered directly into the system, no manual data entry is necessary. Read results can thus be available shortly after a read session.
All BioClinica study reads are performed by independent readers not affiliated with the study either at the location of the independent reader or at a BioClinica site. The reviewers selected for these reads are all licensed, board-certified experts — many of whom hold fellowship training in their respective therapeutic area and meet all FDA requirements as independent consultant readers. Reviewers are selected either by the client or from BioClinica’s network. Curricula vitae are available for client review and approval prior to the final selection of the readers.
With BioREAD You Get:
- Completely customizable questions and pre-defined answer lists with logic that requires all questions to be addressed
- Read protocol workflow enforced by the system, driving the reader’s evaluation
- Customizable images with respect to time on study, modality, anatomic region, etc.
- Electronic CRF with no manual data entry
- Full FDA 21 CFR Part 11 compliance with database transaction audits and electronic reader signatures
- Data exports that accommodate your specifications
- Web portal accessibility from any standard PC with internet access
- A system that can be deployed at a reader’s home or hospital with full support of BioClinica staff
If you’d like to learn more about our Imaging Core Lab Technology Solutions, please complete our request a demonstration form and a BioClinica representative will contact you.