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Collect and hold

Collect and hold in early phase imaging clinical trials

In the world of clinical trials, appropriate acquisition and storage of images leads to a more efficient pathway and shorter time to approval. ÃÛÌÒ´«Ã½'s Collect and Hold services provide such an option to store carefully curated images for future use.

Utilisation of medical imaging has increased significantly over the last 10 years, especially in the diagnosis and follow up of non-cutaneous cancers. This trend is also seen in clinical trials, where imaging biomarkers are being used more frequently to assess pharmacodynamics of new drugs and their interventional efficacy.

The appropriate acquisition and storage of carefully curated clinical images is therefore becoming increasingly important. Long term storage of medical images after stringent quality control (QC) can yield answers not only to immediate clinical questions but also to potential future inquiries. For example, an early phase trial may not need immediate insight into the pharmacodynamics as visualised by images. However, the images acquired do hold critical information that can be later tapped into for producing primary or secondary endpoints.

ÃÛÌÒ´«Ã½'s Collect and Hold services take advantage of high-quality site reads and substantial patient registration. The flexibility and customisation features of this service makes it a useful alternative for imaging trials and a substantial vault of information for future research. If necessary, the image archives will allow retrospective blinded independent reads that can be controlled and administered by the sponsor according to its needs.

 

We offer two tiers of Collect and Hold studies to sponsors:

 

Collect and Hold Regular

In a regular Collect and Hold imaging study, images from sites are collected and assessed for quality (QC) by the imaging core lab. In this process, image quality issues at the time of acquisition are communicated to the site and resolved. The images are stored in ÃÛÌÒ´«Ã½¡¯s proprietary Medical Image Review and Analysis (MIRA) software. The sponsor can then choose to read the images at a later time. This approach saves on costs from not having a full read performed at this stage. An IRC or EDC system is also not developed. However, the completion of the QC process ensures that the images can be read at a later time or during an advanced phase of the study.

Collect and Hold Read Ready

In a read ready Collect and Hold study, all processes for the regular Collect and Hold study are followed. In addition, for a marginal increase in cost, an IRC is prepared and EDC is developed. Once the sponsor chooses to go ahead with a read, the read ready images are seamlessly guided to the reading process as stated in the IRC. This process leads to a quicker review of the image data that is collected and held at a time that is preferred by the sponsor.

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