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.
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, reader performance is routinely monitored by analysis of read rates and 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.
To deliver the highest quality image data and accurate independent review, Bioclinica offers a robust and customizable solution with unique features for metabolic and endocrinology trials including:
- Sophisticated algorithms and analysis tools for quantitative measurements from QCT and DXA modalities
- Precise muscle quantification and body composition measurements
- Specific logic and edit checks based on trial specific endpoints
- Automatic transfer of image analysis data into Electronic Case Report Forms (eCRFs)
Bioclinica's suite of technology solutions help sponsors run faster, more efficient studies and are an important part of our commitment to operational excellence.