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销售价格： ￥ N/A
商品编号： AS-297-1699
软件语言： 英文
器械分类： II
生产厂家： KEOSYS Medical Imaging
公司网址： https://www.keosys.com/
认证信息： FDA
系统要求： Windows
交付方式： 下载安装
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  • 推荐配置
  • 典型病例
  • 软件教程
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软件概览

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Central Imaging

Banook has dedicated the past 25 years to becoming a global leader in medical imaging technology and associated services. Whether you are a large pharma or biotech company, a CRO, or an academic institution, we can help you with your central imaging needs.

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THERAPEUTIC AREAS & INDICATIONS

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WORKFLOW

Key components of a central imaging workflow

Our team provides expertise on your imaging protocol design and tailors the reading scheme to your specific imaging endpoints. We will work with you on the following key documents:

Imaging Manual: Outlines the processes to follow for site qualification, optimal image acquisition by sites, and quality control of the imaging data. 

Imaging Review Charter: details the independent central read procedure of study images, including the management of central readers, the reading methodology and its rationale, and the reading schedule.

Dosimetry Documentation: describes dosimetry equipment calibration procedures, specific imaging acquisition requirements, and how to analyse the data for dosimetry analysis.

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EXPERTISE

Central  imaging reader group

Our global panel of 500+ board-certified experts—each with over 10 years of experience—ensures accurate, specialized readings across therapeutic areas. Experts are radiologists, oncologists, neuroradiologists, nuclear medicine physicians, dermatologists and cardiologists based all over the world.

Our scientific team selects and manages central readers to ensure low variability and minimize bias throughout the study.

We ensure reading consistency through statistical monitoring, consensus sessions, regular re-training, and phantom-based bias checks for quantitative imaging.

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READING CRITERIAS

Accurate imaging starts with the right reading criteria 

We have supported over 350 imaging studies, many in oncology—including pivotal trials—giving us extensive expertise in the following reading criteria:

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We leverage our expertise to guide sponsors in selecting and implementing the most effective criteria to ensure high-quality, consistent data that supports confident decision-making.

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CENTRAL IMAGING MODALITIES

Choosing the right image modality is crucial for achieving trial objectives

We can help you with trials involving all imaging modalities including:

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We collaborate closely with clinical teams during the protocol definition phase to ensure that all imaging challenges are addressed.

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CENTRAL IMAGING IN CLINICAL TRIALS

Why is central imaging important in clinical trials?

Central imaging is crucial in clinical trials as it ensures consistency in image acquisition and interpretation across multiple sites. By standardizing processes, it reduces variability, minimizes reader bias, and enhances data quality. 

This approach improves the reliability of imaging endpoints, making them more robust for statistical analysis. Moreover, central imaging plays a key role in supporting regulatory submissions by ensuring the integrity, accuracy, and traceability of data. 

With a centralized system, you can confidently present consistent, high-quality imaging results that meet the stringent requirements of regulatory authorities.

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推荐配置


典型病例


软件教程


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