BioREAD Imaging Data Solution

BioClinica BioREAD™ imaging data solution consists of hardware and software that is used to evaluate medical images (i.e. perform an independent read) collected during a clinical trial. BioREAD uses software coded specifically for a given trial in collaboration with our sponsor and/or their designee. Each BioREAD data imaging system consists of a database application, which presents a reader with specific questions (eCRF), an image display application to provide tools allowing a reader to maximize visualization of the images and take measurements when applicable, and one or more display monitors. The database and image display applications can reside on the same CPU, or on separate CPUs connected by a local area network. The number of display monitors varies from study to study and is dependent on the number of images that need to be simultaneously displayed.

A reader using BioREAD imaging data solution is presented with an eCRF screen and corresponding questions in accordance with the study-specific read protocol finalized by both BioClinica and the sponsor. The type and amount of supplemental information with which the reader is provided is prospectively determined as part of the read protocol, and is controlled by BioREAD. Logic coded within the data imaging application ensures that all required questions are addressed. Since the data is entered directly into the system, no manual data entry is necessary. Read results can thus be exported shortly after a read session.

BioREAD imaging data solution is modality-independent and has been used for virtually all clinical trials where imaging is an endpoint. The system can be tailored for any specific trial design and can be customized to meet the needs of the sponsor during the contract agreement. If special considerations are needed, they will be addressed and confirmed by both BioClinica and the sponsor before the clinical trial has begun.

Data from independent reads using BioREAD have been submitted to the FDA as part of numerous client New Drug Applications. BioREAD is not subject to pre-approval by the FDA as it is not designed as a standalone system for patient management. However BioREAD has built in compliance with 21 CFR Part 11.

There are many benefits to using BioClinica BioREAD imaging data solution to conduct an independent read:

Completely customizable questions and pre-defined lists of answers.
Customizable images availability with respect to time on study, modality, anatomic region, etc.
Data is entered directly into an electronic CRF — no manual data entry is required.
Database transaction audits and electronic reader signatures ensure 21 CFR Part 11 compliance.
Built-in logic ensures all required questions are addressed, assessment criteria are followed and all pre-defined data consistency is maintained.
Data can be exported to accommodate all client specifications.
Systems can be deployed at a reader’s home or hospital and with full support of BioClinica staff.

For more detailed information on how BioREAD imaging data solution can benefit your clinical trials, please contact us.