远程智能临床试验

远程智能临床试验预示着更高的灵活性与速度,但在不牺牲安全性、数据质量或研究中心工作流程的前提下实现这一目标,仍是一项真实的挑战。

Medidata 的远程智能临床试验(DCT)项目,助力团队运行混合型或完全远程的试验,不仅提升了患者体验,也兼顾了研究中心与申办方的多重需求。依托 Medidata Consent(电子知情同意)、eCOA(电子临床结局评估)及 Sensors(传感器)等专为真实世界执行而设计的解决方案,让远程智能临床试验稳步落地。

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在统一平台上
运行您的 DCT


远程智能临床试验对患者和研究中心提出了全新的要求。从学习使用不熟悉的技术工具,到协调药品配送和实验室样本采集,研究团队还必须确保合规性与数据质量。

您需要一个能够统筹全局、操作简便且高度集成的解决方案。

患者参与解决方案套件
持续临床数据监查
直达患者(DtP)的研究药品配送
与 Circuit Clinical 合作提供一站式解决方案
应用Medidata Trial Dial™ 实现灵活定制化设计

化繁为简,服务每一位参与者

申办方

申办方:
全面掌控,信心十足

中心化监督助力申办方在确保合规性、数据完整性及患者安全的同时,稳步扩展远程智能临床试验(包括混合型及完全远程模式),做到心中有数、成效可靠。

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Video transcript: Felix is a trial manager at Carbon Pharma. His portfolio includes a basal cell carcinoma study with a protocol using a decentralized clinical trial model for trial activities. Felix wants to provide the best experience for patients and sites, including technology that is easy to use and flexible. He's pleased to include Medidata's technology since it puts sites and patients on the same platform. Felix also notes that Medidata's electronic data capture system, RAVE EDC, and other data capture tools will be utilized, and is excited to see that there are multiple sensors in this study, reducing the burden on the patient while improving the quality and amount of data received. Felix sets up a My Medidata pretrial registry to engage, empower, and educate patients on basal cell carcinoma clinical trial opportunities. By setting this registry up in advance of the trial, Felix is enabling faster enrollment as study start up activities progress. He also has goals to include patients from underserved communities. When looking through his list of sites, Felix is pleased to see that Doctor. Aliyah will be participating in the research study, given his prior experience with Medidata's suite of decentralized clinical trial solutions. Felix notes that several circuit clinical sites are also participating in the study, all trained on Medidata's technology. Felix is able to monitor Doctor. Eliya's enrollment in the study, as well as data received in RAVE EDC. He is confident that he will meet his goals for the study start up and reaching underserved patients. Wei is a biostatistician at Carbon Pharma. She works very closely with Felix and the data management team to monitor all study data to spot any potential issues. Wei appreciates the analytic capabilities Medidata has to offer, built directly on the same platform as the data capture tools, giving her real time intelligence into trial performance and data quality. One day, Wei receives an alert through Medidata's centralized monitoring tool that a high volume analysis of data has spotted an unusual finding at Doctor. Aliyah's site. Way raises an issue with Carmela, a data manager from Carbon Pharma, and Felix, the trial manager, detailing the issue and requesting a further investigation with site staff. This ultimately leads to the retraining of the sites and patients, correcting future issues and putting the trial back on track. Following completion of the study, Felix issues an authorization for patient data to be returned to the participant through their My Medidata account. Felix is proud of his work in this patient centric study.
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常见问题解答

是的。该方案具备高度扩展性与灵活性,支持根据需求定制临床试验的远程智能化比例。通过集成Medidata Consent(电子知情同意)、eCOA(电子临床结局评估)及传感器等解决方案,无论试验复杂度或地域分布如何,均能确保高质量的数据采集。

是的。通过与 Circuit Clinical 的合作,Medidata 提供了一套“开箱即用”的解决方案,涵盖了全美范围内支持远程智能临床试验的研究中心网络。这些中心均已接受过 Medidata 技术的专业培训与认证,在扩大患者覆盖范围与多样性的同时,确保了整项研究的标准化。

Medidata RTSM 具备强大的 DtP 功能,为远程智能及混合型试验提供了极高的灵活性。支持在研究中心、访视或患者层面触发药品配送指令,并允许患者通过其 myMedidata 账户直接确认签收。

Medidata 基于统一平台构建了中心化、远程及基于风险的质量管理(RBQM)的监查功能,从根本上解决远程智能临床试验(DCT)的数据质量挑战。这使研究团队能够在不影响研究进度或数据完整性的前提下,从传统的 100% 现场监查转向远程监督模式。

是的。Medidata 为客户及合作伙伴提供多种培训方案,包括自学课程与讲师授课课程。如需查看可用课程并获取相关资源,请访问 Medidata 全球教育与培训中心。

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