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随着对临床证据要求的不断演进,监管机构与支付方期望获取更完整、纵向的,并且涵盖临床试验前、中、后各个阶段的患者结局全貌。

Medidata Link 基于患者水平将临床试验数据与真实世界数据(RWD)安全关联,突破传统临床试验的周期局限,实现连续的证据生成,从而更丰富地呈现患者旅程全景视图。

下载概述
Video transcript: Bringing safe, effective treatments to patients as quickly as possible is the desire for everyone involved in a clinical program. While there have been incredible gains, there's always more that can be done. We can always be better, including when it comes to understanding a patient's journey before, during, and after a clinical trial. Clinical trial data and real world data each provide insight and serve a vital purpose in advancing drug development, monitoring safety and improving patient outcomes. But up until now, they've existed in disparate silos. What if there was a bridge that could connect the two? A bridge that could unlock more powerful insights for the next generation of clinical development. Medidata Link is that bridge. Medidata Link is the first centralized solution that easily connects your clinical trial data to real world data at the patient level. Powered by and fully integrated with the Medidata Clinical Cloud Platform, enabling you to securely collect and manage patient information without additional burden to you, your patients or sites. Metadata's industry leading patient privacy processes ensure information is always protected, keeping data collection safe and secure so you can focus on evidence generation, outcomes analysis, and progressing clinical development. Meddata Link expands your view beyond the confines of a single clinical trial and powers longitudinal insights into safety and effectiveness data, health care resource utilization, and long term outcomes, so you know how your treatment is truly impacting the lives of those you treat. Providing your team with a richer view of the patient journey, understanding their path before the trial, during the trial, and how their journey continues beyond the trial, allowing you to gather meaningful clinical endpoints even for patients lost to follow-up. To generate evidence so your therapy gets into market and to the right patients faster, helping providers make better decisions and developing the next round of treatments. Sponsors are already embarking on this journey to future proof their trials and drive towards the next frontier in clinical development. By combining the power of clinical and real world data, you can bridge evidence gaps and unlock a view of patients never before possible, creating insights that save you valuable time and instilling you with a new level of confidence in clinical decision making.

连接临床试验与真实世界数据

将临床试验无缝接入美国领先的真实世界数据生态系统。在严密管理知情同意与个人身份信息(PII)的同时,最大限度降低研究中心的负担与成本。

覆盖各试验进入节点的灵活 PII 采集
中心化数据关联管理及去标识化标签(Token)生成
全程知情同意管理与合规支持
可配置的去标识化(Tokenization)技术 
研究中心全面赋能与运营就绪

通过 Medidata Link,各团队将有何收益

长期随访

拓展长期随访的深度与广度

依托患者的真实世界数据,即使临床试验已经结束,仍能持续追踪患者长期的疗效与安全性结局。

在不增加患者及研究中心负担的前提下,有效减少失访,并生成上市后的长期疗效与安全性洞察。

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常见问题解答

通过关联临床试验数据与真实世界数据,申办方即使在试验结束后,依然能够持续收集长期的有效性与安全性结局数据。这种方法有助于开展上市后及安全性监测研究,且无需患者进行额外的中心访视,也无需研究中心处理繁琐的行政事务工作。

可以。该解决方案支持研究团队通过患者的常规诊疗数据,持续监测其日常医疗动态。即便患者未能按计划回院进行随访,依然能提供更丰富的治疗与临床结局洞察,从而帮助确保临床试验终点的完整性。

可以。Medidata Link 支持灵活选择数据关联方式,兼容广泛的真实世界数据源以及不同的 Token 供应商。无论是去标识化(基于 Token)的工作流,还是可识别身份(基于患者身份标识)的工作流,它均能提供支持,以此实现临床试验的数据关联。

Medidata Link 稳健管理知情同意状态,确保符合伦理委员会(IRB)与 GCP 规范要求。即便在临床试验结束、研究中心不再可及后,系统依然支持知情同意撤回管理,确保数据隐私保护贯穿患者旅程始终。

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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