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提供商提供赞助商按需,经验丰富的资源,随着试验的进行和转变,可以上升或向下倾斜。但是最有效的FSP模型不仅仅是人民。他们与赞助商合作制定了整体策略,该战略有助于临床研究团队更快,更智能,更有效地工作。
Today, technology advances in the clinical research space are driving an evolution of the FSP model, bringing new approaches for sponsors, while making CRAs jobs easier and more productive.
这些技术并没必威官方在线有消除对CRA的需求。但是它们减少了通常带有复杂且耗时的角色的摩擦。CRA通常监督多个试验站点,收集和上传试验数据,与现场人员接口,监视风险,并确保每个患者都能获得所需的支持。这是一个高压,高转变工作,但是通过周到的技术使用可以缓解挑战和员工过渡。
Here at IQVIA, we’re advancing traditional FSP models by leveraging advanced technologies with the power to support CRAs, making their jobs easier while delivering added value for site staff, patients and sponsors.
这里有一些例子。
Payment bottlenecks disappear
现场和赞助商最大的挫败感之一是调查员支付过程。缺乏透明度的何时付款,欠款以及何时获得付款会产生持续的现金流量瓶颈和勤奋的现场工作人员的不满意。
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’s payment portal eliminates these bottlenecks and provides payment transparency for everyone involved. Site staff and CRAs can log into the portal to review activities and monitor past and pending payments; while sponsors can see what they are paying for and how it effects the budget. They can use the platform to manage payments for every trial and site in their program, which provides instant transparency into cash flow and the data they need to track costs and compare results at a portfolio level.
最重要的是,该共享的付款门户从付款对话中删除了CRA,使他们释放了他们的雇用的试用监督活动。
同意表格保持合规性
Informed Consent Forms (ICFs) are among the most important documents captured in any trial. Every time a patient is recruited for a trial, they have to sign extensive consent forms to participate. They then need to re-sign those forms if they come of age during the trial, or whenevera 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。
在较长的试验中,可能需要患者签署数十个ICF版本,从而使现场工作人员难以管理版本控制。由于对患者是否迄今为止以及目前相关的哪些形式没有透明度,试验很快就会脱离依从性。
对于审计师来说,这是巨大的危险信号。FDA Bioresearch监测计划进行的一项研究发现,不一致的批准/签名/日期同意书排在前三名中most 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.
Strategically align site staff
Study site staff and CRAs can spend hours on low-value, administrative tasks, including uploading documents, closing out queries, tracking site training and copying the same information into multiple forms and fields. IQVIA’s Investigator Site Portal eliminates a lot of that administrative burden, while giving site staff, sponsors and CROS a shared portal to manage all information and tasks.
The portal automates manual tasks, including visit calculators, dosing calculators, patient eligibility forms, clinical supplies requests (the list goes on!), while providing investigator teams a central location for document management, trial information, alerts, updates on recruiting status, and other trial specific information. It also links to site training, newsletters, and other trial communications.
将这些资源在一个位置中,CRA和现场人员可以通过使其与最关键的任务保持一致,可以更轻松地解决他们的任务。结果:提高审计透明度;降低时间表和成本。这也使赞助商,CRO和现场人员轻松监视审判进度。这导致了一支更快乐,更敬业的团队。
These are just a few of the technologies IQVIA uses to support FSP customers and to take the friction out of trial management. When we combine the expertise of seasoned CRAs with these innovative technologies, it optimizes the trial environment, and delivers value for everyone involved.