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Imaging Site Qualification & Image Acquisition Protocol Design

As a full-service Imaging Contract Research Organization, we collaborate closely with sponsors to identify, assess, train, and support MRI, PET, and SPECT imaging facilities for participation in clinical trials. Our team meticulously evaluates all imaging study criteria and adjusts site selection based on their capabilities. Imaging sites undergo a rigorous qualification process to ensure high-quality and reproducible image data acquisition. To streamline this process, we have created an intuitive app that enables imaging sites to navigate qualification seamlessly, while allowing sponsors to track progress in real-time. This seamless qualification and re-qualification capability ensures consistency in acquisition and procedures over time.

Imaging Site Qualification & Image Acquisition protocol

Our team of imaging physicists specializes in creating detailed image acquisition protocols for MRI, PET, and SPECT studies across a wide spectrum of neurological disorders. These protocols are customized for each study, and are designed to produce images of the highest possible quality. Standardization across scanner manufacturers & models, sites, and subjects is crucial to maintaining longitudinal consistency and ensuring accurate, longitudinal, quantitative measures.

Imaging Site Training

Before imaging sites engage in any trial data collection, we provide thorough training sessions. This training is customized to the specific study procedures developed and validated in-house to ensure top-notch acquisitions and a positive site and subject experience. Through our web-based training platform, imaging site personnel receive comprehensive instructions covering all aspects of the study, from image acquisition to data transfer, and personalized troubleshooting procedures.

This self-paced training accommodates the busy schedules of imaging site staff, while ensuring they grasp all of the essential information. One-on-one follow-ups with our team ensure the correct application of the knowledge gained during these trainings.

Imaging Site Training sessions can be done via multiple devices

In-Study Site Support

Our experienced Core Imaging Lab team maintains ongoing communications with the imaging sites. We provide rapid troubleshooting for any aspect of the imaging acquisition through our query management platform. This platform enables communication tracking per imaging site for local staff, the Clinical CRO involved the study, and the Sponsor. Metrics on response time are readily available.

Prompt feedback is also provided for each acquisition to ensure the highest quality of data possible. To facilitate seamless transitions, we offer re-training for any staff turnover and re-qualification for changes in scanners throughout the study. 

Image Transfer & Reconciliation

We utilize a web-based portal, enabling imaging sites to seamlessly transmit images and associated electronic Case Report Forms (eCRFs) to Biospective. This installation-free upload portal ensures end-to-end encryption and a secure file transfer process. As images are uploaded and transferred from the site to our portal, we automate the de-identification and replacement of required DICOM tags in the metadata, thereby safeguarding patient and study information in transit. Additionally, we assess both image quality and protocol adherence to minimize failure rates and maximize usable data for the study.

Our dedicated software platform automatically reconciles the data and provides tailored notifications upon successful acceptance of the scans. Our team is committed to delivering prompt feedback on any acquisition, thereby facilitating timely troubleshooting with the imaging sites.

Image Quality Control Review

As an Imaging Core Lab working on global clinical trials, ensuring the high quality of data for analysis relies heavily on the Quality Control (QC) review of both source and processed images. Initially, data received directly from imaging sites undergoes integrity and metadata QC review within the transfer application, facilitating prompt feedback. Although our image processing pipelines are automated and do not require manual interventions, our thorough post-processing Quality Control review is essential. This process utilizes “verification images” tailored to the study metrics and specific regions-of-interest. Our meticulous Quality Control procedures provide our sponsors with reassurance regarding image data quality.

Study Analytics & Project Management

We have built an analytics platform for continual monitoring of study-related key performance indicators (KPIs). Access to this platform can be granted to any member of the sponsor and Clinical CRO teams involved in the study for real-time monitoring. Our data pipelines communicate directly with the analytics platform to feed data related to imaging site qualification, imaging site troubleshooting, eligibility & safety read metrics, and Quality Control metrics.

Customized metrics can be generated based on our Sponsor’s needs. Real-time tracking of these analytics allow for immediate action being taken whenever troubleshooting is warranted.

Learn more about our Imaging Study Operations services for early to late phase clinical trials.

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ELIGIBILITY & SAFETY READS

IMAGE PROCESSING & ANALYSIS

FAQs

How does Biospective ensure the integrity and quality of images obtained during data acquisition?

At Biospective, reproducibility is key. Our Neurology CRO services include providing imaging site qualification and comprehensive imaging site staff training, which facilitate the adherence to standardized acquisition protocols. As a Neurology CRO focused on neuroimaging, our procedures are designed to set-up and train all imaging sites as similarly as possible to minimize inter-site variability.  Our rigorous quality control (QC) review of incoming data also maximizes the quality of the images acquired.

What are the best practices for transferring images securely between imaging sites and Biospective?

Data security is an essential component of our Imaging Contract Research Organization services. At Biospective, we utilize a web-based platform for convenient and secure upload and transfer of images. No on-site installation of software or portals is required. The platform has comprehensive role-based access controls, and imaging site staff are provided with personalized, secure credentials to interact with the platform. As part of our Imaging CRO services, images are de-identified during the transfer process. All data is encrypted in transit and at rest on the platform.

How does a site troubleshoot common issues encountered during image transfer?

Our Imaging Core Lab services include providing assistance during all stages of the study. Using a Query Management ticket system, we can access, answer, and keep track of any question with a fast turnaround time. The study team can also be contacted via study-specific communication channels (email, video call, phone call, etc.) for urgent and real-time support.

What quality control measures should be implemented during image processing to maintain data accuracy?

As an integral part of our Core Imaging Lab services, Biospective uses both manual and automated Quality Control (QC) checks for image headers, image artifacts, and study-specific criteria based on study requirements.

What are particular challenges associated with neuroimaging endpoints in clinical trials?

Neuroimaging endpoints are often multi-modality (e.g. MRI, PET, SPECT). Quantitative imaging biomarkers used in clinical trials of neurological diseases can be very powerful for assessing therapeutic efficacy. However, image quality must be high to allow for computation of these measures.

As a Neuroscience CRO, our team has the expertise and experience to work with our Sponsors, ranging from small-to-midsize biotech to multinational pharmaceutical companies, on the optimal implementation of neuroimaging in early to late phase clinical trials. Our Neuroscience CRO services have been specifically developed to facilitate the acquisition of superior quality source data to allow for sophisticated image processing & analysis.   

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