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Selecting an Imaging Contract Research Organization for Orthopaedic Clinical and Preclinical Research

Introduction

As the use of medical imaging in clinical trials and manufacturing quality assurance continues its rapid increase, orthopaedic device companies face an array of complexities. In many cases, imaging technologies (CT, MRI, PET, x-ray, etc.) can speed the process of proving product efficacy and safety. However, keeping track of the rapidly-changing imaging and image analysis technology landscape can be challenging.

To assist with the imaging components of their work, clinical trial sponsors often turn to imaging core laboratories or central imaging laboratories. These organizations help secure consistent, high-quality imaging data and ensure minimal variability through centralized radiologist image reading and analysis. They also guide sponsors in selecting the best combination of imaging modalities, designing and evaluating appropriate image acquisition protocols, providing study site imaging oversight and compliance and offering quality control and image data management, throughout.

An emerging alternative is use of an imaging contract research organization (ICRO) that employs a combination of imaging, image analysis, biomedical and software engineering expertise along with customizable software for image analysis, data capture and management. Custom-tailored image analysis algorithms can be used in lieu of time and cost-intensive manual processes, reducing guesswork, cost and time associated with preclinical and clinical studies. Particularly adept ICROs can leverage their expertise to translate the quantitative image measurement into valuable 2D and 3D marketing collateral to help study sponsors bridge the gap between product regulatory approval and market adoption. While the following is not an exhaustive list of ICRO critical features, it does provide a strong foundation for evaluating an ICRO to support your next preclinical or clinical study.

Operational Abilities

Some ICROs specialize in a specific therapeutic area, or in support of preclinical vs. clinical studies. On-site vs. off-site access to professional staff (e.g., radiologists and pathologists) to read and provide or validate image analysis outputs is an important consideration, as an on-site staff means the sponsor can expect better access to expertise, better turnaround time and fewer potential logistical concerns. Further, an on-site professional staff gives the ICRO greater control over the quality of the manually scored image data (1). On the other hand, on-site clinical staff can often translate into higher costs and reduced access to a broader range of clinical sub-specialty expertise.

One often overlooked aspect of an ICRO’s operational prowess is its ability (and willingness) to provide image acquisition and data management support and expertise to researchers, clinicians and technicians at remote study sites to optimize and standardize imaging equipment and protocols across multiple sites. Since clinical 3D imaging modalities have such low resolutions (relative to modalities like Micro-CT), an ICRO’s ability to help technicians fine-tune and optimize a CT or MRI scanner can mean the difference between “okay” and exceptional data. Given the inter-vendor and inter-model variability and complexity for a given imaging modality, it’s easy to see how resulting study data variability can become quite large if not dealt with prior to study initiation. Finally, as a result of the inherent differences in preclinical and clinical imaging modalities (e.g., resolution, image acquisition time, field-of-view, radiation dose, etc.), an ICRO with expertise in both can add a great deal of value by helping a sponsor successfully translate preclinical product efficacy outcomes into clinically relevant clinical trial efficacy end point measurements.

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