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支持未来的CRA
技术如何使摩擦退出试用管理
Melissa Easy, Vice President, R&D Solutions, IQVIA Technologies
Jun 25, 2020

临床试验几乎每天都在持续不断变化,科学和技术进步几乎每天都报道。这使员工变得复杂。如此流畅的环境并不能够雇用全职人员,这就是为什么如此多的赞助商依靠功​​能服务提供商(FSP)模型的原因。

FSP providers deliver sponsors on-demand, seasoned resources who can be ramped up or down as a trial progresses and shifts. But the most effective FSP models are about more than just the people. They work in partnership with a sponsor to develop a holistic strategy that helps clinical study teams work faster, smarter and more efficiently.

如今,临床研究领域的技术进步正在推动FSP模型的发展,为赞助商带来了新的方法,同时使CRAS的工作变得更加容易,更有生产力。

These technologies don’t eliminate the need for CRAs. But they reduce the friction that often comes with a complicated and time-consuming role. CRAs typically oversee multiple trial sites, collecting and uploading trial data, interfacing with site staff, monitoring risks, and making sure every patient receives the support they need. It’s a high-pressure,高转变job, but challenges and staff transition can be eased through the thoughtful use of technology.

在IQVIA,我们通过利用高级技术来支持CRAS,使他们的工作更加容易,同时为现场人员,患者和赞助商提供附加值,从而推进了传统的FSP模型。必威官方在线

这里有一些例子。

付款瓶颈消失了

One of the biggest frustrations for sites and sponsors is the investigator payment process. Lack of transparency about when sites are going to be paid, what they are owed, and when they get a payment creates constant cash flow bottlenecks and dissatisfaction among hard-working site staff.

克拉斯首当其冲。他们是现场工作人员与CRO和赞助商的主要联系,因此他们成为所有付款要求和投诉的接收者。这为CRA创造了许多额外的工作,他们需要追逐答案并充当网站,赞助商和CRO之间的通信桥梁。

IQVIA的付款门户消除了这些瓶颈,并为参与的每个人提供了透明度。现场工作人员和CRA可以登录门户,以审查活动并监视过去和待处理的付款;尽管赞助商可以看到他们要支付的费用以及如何影响预算。他们可以使用该平台来管理其计划中的每个试用和网站的付款,这将现金流的即时透明度以及他们在投资组合级别跟踪成本和比较结果所需的数据。

Most importantly, this shared payment portal removes CRAs from the payment conversation, freeing them to focus on the trial oversight activities for which they were hired.

同意表格保持合规性

知情同意书(ICF)是任何审判中最重要的文件之一。每次招募患者进行试验时,他们都必须签署广泛的同意书才能参加。然后,如果他们在审判期间或任何时候都需要重新签署这些表格a protocol amendment occurs。协议修正案采用多种形式,可以包括改变治疗的风险/收益概况,研究程序的变化或获得新替代治疗的新发现。

In longer trials, patients may be required to sign dozens of versions of the ICF, making it very difficult for site staff to manage version control. With no transparency into whether patients are up to-date, and which forms are currently relevant, trials can quickly fall out of compliance.

That is huge red flag for auditors. One study conducted by the FDA Bioresearch Monitoring Program found that inconsistently approved/signed/dated consent forms ranked among the top threemost frequently cited findings由2015年至2018年临床审判检查员。

IQVIA的Econcent平台消除了这种风险。患者通过自动化系统签署了所有同意书,因此始终使用最新版本,并且患者还可以访问视频和内容,以解释同意过程和研究,以使其对患者更加友好。

每当ICF发生更改时,系统都会提醒调查人员和CRA,必须完成该表格的更新版本,以确保它们保持合规性。

It provides frictionless consent form management, that reduces safety risks, and gives CRAs digital access to the status of these important patient documents. This allows them to manage the paperwork remotely so they can spend more time on-site engaging with staff. And when inspectors audit these sites, they are able to determine instantly whether the forms are up-to-date.

从策略上调整现场人员

研究站点的工作人员和CRA可以花费数小时的时间来执行低价值,管理任务,包括上传文档,关闭查询,跟踪站点培训并将相同的信息复制到多种形式和领域中。IQVIA的调查员网站Portal消除了许多行政负担,同时为现场工作人员,赞助商和CRO提供了共享的门户,以管理所有信息和任务。

门户网站自动化手动任务,包括访问计算器,剂量计算器,患者资格表格,临床用品请求(列表继续!),同时为调查员提供了一个中心位置,以进行文档管理,试用信息,警报,招聘状态的更新,以及其他特定于试验的信息。它还链接到现场培训,新闻通讯和其他试验通信。

With these resources in a single location, CRAs and site staff can more easily tackle their tasks by aligning them to the most business critical tasks. The result: improved audit transparency; reduced timelines and costs. It also makes it easy for sponsors, CROs and site personnel to monitor trial progress. That leads to a happier and more engaged team.
这些只是IQVIA来支持FSP客户并将摩擦带出试验管理的必威官方在线一些技术。当我们将经验丰富的CRA的专业知识与这些创新技术相结合时,它可以优化试验环境,并为参与的每个人提供价值。必威官方在线

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