Bioclinica takes careful measures to ensure that the data you receive is of the highest quality and meets regulatory compliance. Initial site qualification, ongoing site quality assurance, and quality neuroimaging data all have a key impact on the overall quality of data emerging from a trial.
Survey and standardization of clinical sites
A technical survey is performed at each participating site to collect important information regarding image acquisition equipment and software specifications enabling Bioclinica to provide each site with vendor- and model-specific image acquisition parameters.
ACR phantom data
Phantom scans allow for the assessment of acquisition and image quality at each clinical trial site. Bioclinica uses American College of Radiology (ACR)-approved phantoms for site qualification and for monitoring the image quality and consistency over the course of a trial. All sites used in a study must be able to provide images of sufficient quality during the course of the study, acquired in compliance with the image acquisition protocol.
Upon phantom image acquisition, Bioclinica evaluates:
- The proper use of image acquisition parameters
- Geometric accuracy
- MRI signal intensity inhomogeneity
- Level of ghosting artifact
- Detection for high and low contrast objects
Sites are trained using a combination of the training strategies including:
- Presentation at Investigator's Meetings
- Distribution of training materials
- WebEx training sessions
- Secure, web-based training modules
Close monitoring and interactions with clinical sites provide a unique opportunity to detect any major quality findings (deviations in acquisition parameters, subtle alteration of image quality, occurrence of missing data, etc.) and resolve image queries quickly helping sponsors adhere to trial workflow and timelines.
An important requirement for introducing quantitative MRI endpoints in the design of Neuroscience trials is the accuracy and reproducibility of the analysis techniques. Once images are captured, they undergo rigorous quality control (QC) to ensure accurate quantitative analysis.
Our validation process includes the following checkpoints:
- Verification of scan quality
- Protocol compliance
- Data anonymization
- Verification of correct file format
- Identification of corrupted images
- Patient positioning
- Slice orientation
- Movement artifacts
- MRI artifacts (movement, aliasing, susceptibility, etc.)
- Missing images or sequences
- Confirmation of imaging parameters (e.g., slice thickness, spacing, field of view, etc.)