RFP

临床试验解决方案

随机化和药品供应管理系统及服务(IRT)

凯理斯丰富的经验和卓有成效的 IRT 系统能优化随机化和临床试验供应管理 (RTSM) 流程,从而助推您的开发项目。

临床试验解决方案

随机化和药品供应管理系统及服务(IRT)

凯理斯丰富的经验和卓有成效的 IRT 系统能优化随机化和临床试验供应管理 (RTSM) 流程,从而助推您的开发项目。

合适的治疗, 正确的患者,恰当的时间

凯理斯 IRT 是一种可靠的随机化和试验供应管理 (RTSM) 解决方案,在逾 4,500 项研究中经证实能降低风险,优化供应确保试验申办方和 CRO 通过可靠、灵活、准时的药物给与完成关键里程碑。

拥有一些行业内经验最丰富的 IRT 专业人员和一种经过逾近 30 年演变的解决方案,应对制药行业不断面临的各种挑战。

凯理斯 IRT,一种值得您信任的解决方案,始终提供让您满意的服务。

 

合适的治疗, 正确的患者,恰当的时间

凯理斯 IRT 是一种可靠的随机化和试验供应管理 (RTSM) 解决方案,在逾 4,500 项研究中经证实能降低风险,优化供应确保试验申办方和 CRO 通过可靠、灵活、准时的药物给与完成关键里程碑。

拥有一些行业内经验最丰富的 IRT 专业人员和一种经过逾近 30 年演变的解决方案,应对制药行业不断面临的各种挑战。

凯理斯 IRT,一种值得您信任的解决方案,始终提供让您满意的服务。

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Get answers to your questions about Calyx IRT and gain the confidence you need to drive your trial’s success!

Discover the Calyx IRT Difference

使用Calyx经过验证的流程,您将会在IRT上花费更少的时间,将更多时间花费在试验上。From initiating the IRT design to database lock, Calyx’s expert project teams recommend the best functionalities to meet your protocol requirements, increase RTSM efficiencies, and adapt to unplanned situations.

IRT 系统益处剖面图

Discover the Calyx IRT Difference

IRT 系统益处剖面图

使用Calyx经过验证的流程,您将会在IRT上花费更少的时间,将更多时间花费在试验上。From initiating the IRT design to database lock, Calyx’s expert project teams recommend the best functionalities to meet your protocol requirements, increase RTSM efficiencies, and adapt to unplanned situations.

化繁从简

凯理斯 IRT 有数十年的经验作为基础,由行业内经验最丰富的项目团队设计,简化了 RTSM 的复杂难题。From simple blocked and stratified designs to more complex adaptive trial designs, Calyx IRT delivers advanced randomization and trial management suitable for all trials.

可调节功能

作为一个在逾 4,500 项试验中测试过的系统,凯理斯 IRT 使用自动工作流程、自助工具和报告来满足每项试验和每位系统用户的独特需求。Take advantage of flexible, robust medication management algorithms, simplified study and site management, and protocol-tailored patient management, including Direct-to-Patient shipments with Calyx IRT.

Seamless Integrations

By integrating Calyx IRT with other eClinical systems, sponsors boost productivity and improve data quality, reducing the need for data duplication and reconciliation at the end of the trial. Calyx enables everything from simple IRT-to-EDC integrations to more complex, blinded central lab integrations and electronic patient reported outcome (ePRO) scoring.

加速研究启动

是否需要迅速开始研究?通过充分利用预定标准,凯理斯在质量标准签发后仅 4 周就可以提供可靠地 IRT 系统进行用户验收测试。凯理斯经验丰富的团队将根据其开展和支持试验的丰富经验就最佳 IRT 设计提供建议。

提高数据质量

Calyx IRT minimizes data errors through real-time data entry validation, reduces the need for data duplication through flexible integrations, and reduces ambiguity during data capture by guiding sites on how and when to enter patient data in alignment with the protocol. And Calyx IRT is configured to reduce the risk of unblinding, randomization imbalance, or mis-dispensing, resulting in increased protocol compliance and high data quality.

Reduce drug wastage

With advanced inventory management algorithms that automatically direct supply to recruiting sites’ needs, and specific trial- and program-level waste reduction strategies, Calyx IRT can help balance the costs of drug production and shipment, reducing the amount of drug wasted during clinical trials and minimizing your organization’s carbon footprint.

化繁从简

凯理斯 IRT 有数十年的经验作为基础,由行业内经验最丰富的项目团队设计,简化了 RTSM 的复杂难题。From simple blocked and stratified designs to more complex adaptive trial designs, Calyx IRT delivers advanced randomization and trial management suitable for all trials.

可调节功能

作为一个在逾 4,500 项试验中测试过的系统,凯理斯 IRT 使用自动工作流程、自助工具和报告来满足每项试验和每位系统用户的独特需求。Take advantage of flexible, robust medication management algorithms, simplified study and site management, and protocol-tailored patient management, including Direct-to-Patient shipments with Calyx IRT.

加速研究启动

是否需要迅速开始研究?通过充分利用预定标准,凯理斯在质量标准签发后仅 4 周就可以提供可靠地 IRT 系统进行用户验收测试。凯理斯经验丰富的团队将根据其开展和支持试验的丰富经验就最佳 IRT 设计提供建议。

提高数据质量

Calyx IRT minimizes data errors through real-time data entry validation, reduces the need for data duplication through flexible integrations, and reduces ambiguity during data capture by guiding sites on how and when to enter patient data in alignment with the protocol. And Calyx IRT is configured to reduce the risk of unblinding, randomization imbalance, or mis-dispensing, resulting in increased protocol compliance and high data quality.

Seamless Integrations

By integrating Calyx IRT with other eClinical systems, sponsors boost productivity and improve data quality, reducing the need for data duplication and reconciliation at the end of the trial. Calyx enables everything from simple IRT-to-EDC integrations to more complex, blinded central lab integrations and electronic patient reported outcome (ePRO) scoring.

Reduce drug wastage

With advanced inventory management algorithms that automatically direct supply to recruiting sites’ needs, and specific trial- and program-level waste reduction strategies, Calyx IRT can help balance the costs of drug production and shipment, reducing the amount of drug wasted during clinical trials and minimizing your organization’s carbon footprint.

有效的RTSM系统久经考验,积累丰富经验

正确执行随机化以及将物品准时送达研究中心是一项具有风险的业务。信赖凯理斯 IRT 及其背后数十年的经验,降低 RTSM 风险,帮助您的试验取得成功。

逾 4,500 项
试验
逾 260 万名
患者
500 次
获批
获支持的
逾 250 款
适应性
试验
逾 4,500 项
试验
逾 260 万名
患者
500 次
获批
获支持的
逾 250 款
适应性
试验

专业知识很重要。

迄今为止,凯理斯已成功参与逾 4,500 项研究,支持了逾 500 次监管批准,经证实能提供可靠、有效的 RTSM。适用于所有治疗领域、所有阶段、所有试验设计。

凯理斯在过去 5 年内的 IRT 经验

在各治疗领域内的经验
在各治疗领域内的 IRT 系统经验图形

Advanced Features Drive Trial Success

The technical experts behind Calyx IRT understand the randomization and trial supply issues that can impact the success of clinical trials. Based on decades of experience delivering effective and efficient RTSM, the following advanced features are available to help clinical trials succeed:

IRT 系统对齐点

Enhanced Self-service Tools

Calyx IRT puts the power back into the hands of trial sponsors and system users, with access to real-time data and the ability to make immediate changes as needed. This includes everything from simple changes such as an investigator correcting a patient’s date of birth, closing screening, or increasing enrolment caps at any level to the complex, such as immediately adding new doses for new cohorts of patients, adding new countries to accelerate recruitment, or closing treatment arms following a safety review.

IRT 系统对齐点

Advanced Inventory Management Algorithms:

Automated Supply Strategy Management takes the burden of monitoring site stock away from the clinical supply manager by automatically adapting the amount of medication shipped to sites based on the number of patients in screening.  As a result, patients at recruiting sites are assured drug supply, while drug wastage and the risk of failed visits are reduced.

Medication Pooling reduces drug wastage and addresses drug availability concerns by sharing medication across different protocols in a single program. Calyx IRT controls the sharing of medication across protocols and facilitates just-in-time labeling, drawing on a wealth of experience supporting a range of different sponsor pooling methods and labeling plans.

Randomization Prediction When randomization codes are dedicated to the site, Calyx IRT can reduce drug wastage by sending IMP to each site specific to upcoming treatment group assignments.

IRT 系统对齐点

Calyx applies advanced IRT algorithms to address the unique challenges of cell and gene preservation during these complicated clinical trials.

IRT 系统对齐点

Task Manager

Calyx IRT task manager functionality improves efficiencies by presenting a summary of patient visits that, according to the protocol, need to be registered within the next 24 hours and enables site personnel to quickly see which visits are due in the coming week/s. By elevating this important information, Calyx IRT Task Manager saves valuable time for busy site personnel and makes it easier for them to meet protocol requirements.

IRT 系统咨询

凯理斯 IRT 专家运用 100 年的累积经验,应用先进技术优化 RTSM,让凯理斯客户能够开展有效、高效的临床试验。

无论您的试验简单还是复杂,是当地试验还是全球试验,纳入 50 名还是 5,000 名患者,都会有一些行业内经验最丰富的 IRT 专业人员来帮助您充分利用您的 IRT 系统,使您的试验取得成功。

IRT 系统咨询

凯理斯 IRT 专家运用 100 年的累积经验,应用先进技术优化 RTSM,让凯理斯客户能够开展有效、高效的临床试验。

无论您的试验简单还是复杂,是当地试验还是全球试验,纳入 50 名还是 5,000 名患者,都会有一些行业内经验最丰富的 IRT 专业人员来帮助您充分利用您的 IRT 系统,使您的试验取得成功。

文库

使用凯理斯 IRT 探索凯理斯的与众不同之处

通过凯理斯 IRT 增加对 RTSM 的信心,凯理斯 IRT 是一个非常可靠的系统,该系统基于数十年的经验,并出于业界最富有经验的项目团队之手。
阅读更多内容

通过有效的 IRT 伙伴关系提高效率

结合了 IRT 标准的项目管理方法如何克服困难,消除 RTSM 相关压力,并让研究团队能够集中精力满足其他研究开发需求?阅读本案列研究。
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Optimizing Supplies with Calyx IRT: Ensure Patient Supply while Limiting Buffer

Calyx IRT provides a complete, integrated solution for managing and optimizing supplies. Learn about Calyx RTSM expertise.
阅读更多内容

Reducing Overage with Calyx IRT: Minimize Monitoring Burden while Optimizing Supplies

Calyx IRT provides a complete, integrated solution for managing and optimizing supplies. Learn about Calyx RTSM expertise.
阅读更多内容
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