From study initiation and enrollment through maintenance and closeout, Bioclinica provides exceptional quality and services to maximize the efficiency of a clinical trial. From the start, our experts will help design and develop Imaging protocols and Imaging Review Charters (IRC) to make sure that all image acquisition specifications are understood and adhered to by participating sites.
As part of our investigational site qualification process, we implement Site surveys and Study kits to communicate technical information for image acquisition. This ensures that all sites have the information they need to acquire and deliver high quality images to our centralized database for independent review.
Accurate and unbiased review of medical images is critical to the success of your clinical trial. Bioclinica provides expert independent review and image analysis. For each trial, a customized system is developed to accommodate trial specific imaging endpoints. Prior to image review, Bioclinica hosts a Mock read complete with training cases to develop the read rules. In addition, reviewer performance is routinely monitored by analysis of adjudication rates.
Prior to the completion of a trial, Bioclinica ensures that all data is properly reconciled and archived in compliance with 21 CFR Part 11.
With quality and efficiency as the driving factors, our solutions allows for images to be transferred, processed and evaluated within a fully integrated system, ensuring that data quality, study timelines and budgets are managed efficiently.
Bioclinica's robust and customizable solution offers:
- High quality image data and accurate independent review.
- Specific logic and edit checks based on trial specific response criteria.
- Automatic transfer of image analysis data into Electronic Case Report Forms (eCRFs).