Medidata
+ Cogstate

中枢神经系统(CNS)适应症具有高度异质性,这使得临床试验的测量工作异常复杂。其涉及的认知与行为评估繁琐且精细,极易导致数据变异性。

为应对这一挑战,Medidata 与 Cogstate 携手合作,为 CNS 试验提供全面且深度集成的解决方案,旨在精简运营,同时确保终点数据质量达到最高标准。

下载概述
Video transcript: Hey, Brad. Thanks for joining us. Really excited about this partnership. I can't thank you enough for what you guys have done for Medidata and helping us get into this space. But why don't you take a second and introduce Cogstate to the audience and make sure everyone knows who you guys are? Sure. So not many of you maybe have heard about Cogstate, but we've been doing this for more than twenty years now. We started the company in Melbourne, Australia with an understanding of the importance of brain health in an aging population. We originally started by, as a digital disruptor in the area of cognitive assessment, so we developed computerized cognitive assessments. We validated those extensively with over five hundred peer reviewed publications supporting that technology. Our tech's been accepted by regulators, we're a class two medical device here in the United States. In twenty twenty we were really proud to partner with Aisai. Aisai is a Japanese pharmaceutical company who's just launched the first ever disease modifying drug for Alzheimer's disease. They're taking our technology into primary care physicians' offices here in the United States to help find patients who will benefit from those drugs. So that's sort of our origin story but you know, over the course of twenty five years with a really deep bench of scientific strength, what we've done is really evolve into an endpoint data quality company. We help pharmaceutical companies to ensure that in central nervous system disease trials, the assessments are complex the complexities of training raters all over the world is difficult, we make sure that we bring both science and technology to that to ensure that data quality in small studies with biotech companies in rare disease all the way through to global phase three successful Alzheimer's disease trials. Yeah. So let's talk a little bit more about some of those service offerings around the technology. So can you talk a little bit about kind of your radar training and central review capabilities and how do you how do you help make sure that technology is used appropriately in these studies? Yeah. So it's it's really important that when you're running a global central nervous system disease trial, the idea is that most of these assessments are being developed assuming you've got a patient delivering that a doctor delivering that to a patient one on one, and we're taking that to twenty countries in thirty seven languages. And what really we wanna do is reduce the error. So training those raters to deliver that in exactly the same way is critical. And and to the extent we can reduce the error, we will increase the signal strength and therefore, you know, help to deliver a much more successful trial. But what in in doing that, we have to have, you know, people who can review that data, so other humans who essentially review that data to make sure that that's being delivered in the right way. Yep. Great. So we have a rater training program up front. We can then use the metadata application to capture all that data and execute those visits. We've got a central review process on the back end. So we think CogState and metadata together can really make that whole experience one of the best experiences out there in the market. But I think neither of us want to stop there. We really want to go beyond the current version of what's out there to support CNS studies and create something even better. So I can wonder if you talk wanna talk a little bit about how our team's been working together to kind of take some additional steps in this whole process. Yeah. So the I think the first thing is to understand the real depth of the collaboration between metadata and Cogstate. That's been really important to us. Building that infrastructure that exists now to really work seamlessly between Cogsdata and Medidata. But this is an area that's ripe for disruption. Mean, we're running these trials in the same way essentially as we've done for twenty, thirty, forty years. And we have this wealth of data and we understand what patients look like, we understand the mistakes the raters make when they're delivering these assessment. And the opportunity to build a model and and bring tech you know, bring AI and the benefit of that to that to automate error detection, and then ideally stop the error from occurring in real time. And I think that's really what the exciting opportunity is. Yeah. So our team's been working together. You can see some of the items up on the screen to try to really take this data and actually, like you said, in the moment, try to error correct and give insights to clinicians as they're executing these studies to really move way past the current paradigm. Cool. Hey, Brad, thank you so much to you for coming on stage today and for your partnership with us. We are super excited to get this joint offering out to the market. It's a pleasure. Thank you.

打造互联的 CNS 试验执行方法

认证评估者

自动化准入门槛

评估者在完成 Cogstate 的评估者培训与认证项目后,将自动获得 Medidata eCOA 表单的访问权限,确保只有具备资质的用户方可实施 CNS 评估,从而在源头上确保一致性。

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Cogstate 数据质量解决方案

作为认知测量领域的行业领导者,Cogstate 将科学底蕴与运营实力深度融合,致力于交付精准、可靠的 CNS 数据采集,确保临床试验各个阶段均能达成高质量结果。

查看 CNS eCOA 指南

Cogstate 科学专长

Cogstate 拥有一支 CNS 专家团队,可就认知和临床结局评估的各个方面提供全面指导,确保试验申办方获得量身定制的支持和深度洞察,从而实现精确的数据采集。

量身定制的评估者培训和认证

Cogstate 提供根据评估者经验量身定制的认证路径,包含由临床专家倾力打造的在线课程,这些专家对评估量表以及评估者的常见错误拥有丰富的第一手实操经验。多元化的培训方法可确保高效的学习效果与知识巩固,从而全面赋能评估员在临床试验中实施高质量、可靠的评估。

策略性与基于风险的中心化监查

Cogstate 的中心化监查服务通过严格的专家审阅,确保数据的高度可靠性。借助定制化的数据驱动算法,系统可快速识别潜在的评估者错误,以便临床专家针对施测流程进行审阅。

临床专家中心化评估

通过远程医疗系统对接经验丰富的中心化评估者,可在确保数据质量的同时,减轻研究中心负担,无论是在试验中心还是在患者家中,均能提供灵活且以患者为中心的评估。

经科学验证的 Cogstate PerfO 测量组合

Cogstate 的数字化认知评估在支持监管沟通与获批方面拥有良好纪录,能够显著提升认知功能测量的敏感度与特异性。此外,其全自动评分机制无需专家评估者参与;并且,其测试数据已多次成功助力监管沟通与获批。

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