柯维德试验

Meet Me in 5: A cross-organizational team delivers a COVID-19 study in record time

我们的“在5”系列中遇见了5个人,主题或问题,以说明我们的商业培育人们如何出色,提供了一种充满活力的目的,并能够实现员工的职业生涯的非凡潜力。

Every day counts in the fight against the COVID-19 pandemic. That’s why Covance, LabCorp’s drug development business, was ready to move quickly when a U.S. biotech company called to see if we could help them begin testing in healthy volunteers with their promising antiviral drug.

超过40名员工跨越几个网站的员工迅速调动,以在流程的每个阶段提供记录破碎的周转时间,这使得先进的第一人体测试。对于通常需要六周的时间表,他们计划在仅14个工作日内第一次患者访问。我们与其中一些员工讨论了他们在这一伙伴关系中的经验,为患者提供潜在的救生治疗方法,更快。


“我支持我们的欧洲队伍和合作伙伴,与我们的三个基于美国的临床药理学诊所,帮助客户带来了他们的第一审判,”詹姆斯解释道。“通常,当客户想与我们合作时,我们将在五到十个工作日内放在一起提案。”

詹姆士
经理,提案管理
Leeds, UK

For this COVID-19 project, James and his team had just one day to propose the budget for the client’s nine separate studies. “With my team members, and drawing on our past experience with these studies, we worked for the next 14 hours and by 10:30 that evening, we had created our estimates and sent it to the client,” he said.

詹姆士recognizes the effort and the energizing purpose of his team’s work. “This project really hit home about why our work matters. We are already dosing in the clinic, and seeing that side makes you realize what an important job you are doing and makes you proud to work for the company.”


在COVID-19项目的监管方面,艾丽西亚的两个团队成员开始行动,将客户的美国CMC文档转换为英国药品和保健品管理机构(MHRA)的临床试验授权(CTA)格式。

艾丽西亚
Executive Strategist, Head of Biosimilars Center of Excellence
普林斯顿,新泽西州,美国

“在一个典型的研究回顾中,MHRA在14天后批准了一个正常健康志愿者的研究,但是由于COVID-19的紧迫性,他们促成了一个更加合作的过程。我们与MHRA进行了一次滚动提交,来回评论、纠正和完善核心文件。我的团队行动如火如荼,工作了很长时间来完成客户的研究性医疗产品档案(IMPD),以便在短短三天内获得批准的CTA,”艾丽西亚解释说。

“我们为客户实现的速度相当惊人,”她说。“在监管领域,政府机构、赞助者、科学家和首席风险官之间的合作是一个非常令人兴奋的时刻。每个人都会团结起来接受这个挑战。”


Bola’s team was asked to evaluate the proposed study and determine where they could use remote and virtual trial elements, such as telemedicine/telehealth, electronic consent forms (eConsent), mobile phlebotomy (blood draws) and mobile nursing services, in downstream trials after the First-in-Human study.

Bola
Vice President, Global Head Decentralized Clinical Trials
罗利,北卡罗来纳州,美国

博拉解释说:“我们经验丰富的分散式临床试验团队剖析了客户的方案,以了解哪些活动可以在患者不访问研究者现场的情况下进行,这对于COVID-19危机是一个重大挑战。”。“在试验中添加虚拟技术和方法实际上可以减少患者前往研究者现场的负担,从而提高患者的参与度,但它也可以帮助客户优化研究执行期间的数据收集,并确保试验的安全监控可以继续。”

Bola认识到他的团队工作的重要性通过分散的临床试验增加患者外展。“我们在将创新疗法带到市场拯救生命的业务,我已经看到了我们在Covid-19大流行期间加强了我们在Labcorp企业的日常工作的重要性。我感到非常幸运能够成为一个致力于改善患者生命的团体的一部分,并加速治疗疾病,如Covid-19,影响全世界。“


Marie was the first costing director at Covance and over the last decade has worked to develop the budgets for many large drug development studies – including a major blockbuster drug. Creating a detailed budget typically requires two weeks as her team accounts for many factors, such as the complexity of the trial, patient inclusion/exclusion criteria, dropout rates and the number of sites needed to support the study.

Marie
Project Director of Costing
纳斯维尔,田纳西州,美国

“这个电话进入了一天早晨,我们在八小时内为生物技术公司提供了整个计划。我们以前从未这样做过,“玛丽解释道。“出于危机来创新,我们在压力下,我们上升到顶端工作协同工作。这项任务确实让我们在盒子外工作。“

自从最初制定预算以来,Marie的团队已经为他们的成本计算工具开发了一种新的算法,以自动包括备用研究站点,从而为额外的紧急COVID-19研究预算提供更快的周转时间。

“很高兴知道你是我们社区中积极影响人们的一部分。你所做的工作很有回报,我们不仅仅是一家普通的公司。我看到了这里的一切都是一成不变的——你必须迅速适应新的形势。这个项目并不容易,但我们可以应付任何挑战。”


当面对来自生物技术公司的快速周转要求时,Agata和COVID-19治疗交付监督团队决定了他们可以在各个层面上帮助缩短时间。

“We reached out to our core functional areas, asking them what they could offer for a COVID-19 study to negotiate unprecedented delivery,” said Agata. “For example, with medical writing, it typically requires twelve weeks to write the protocol and we reduced that to a maximum of 10 days, and in the case of the biotech company, we turned it around in just three days. We also identified project managers with therapeutic area experience to advance COVID-19 studies so they are ready to work on any project immediately. It was a huge effort, and I saw how everyone was really motivated and willing to go the extra mile.”

agata.
COVID-19治疗区负责人
克拉科夫,波兰

支持生物技术公司之后,Agata的团队has organized their processes to deliver the same turnaround times as they continue to manage additional requests from other drug development companies.

agata.finds that her work on COVID-19 studies also highlights the importance of bioethics and the value of clinical trials.

“我对生物伦理​​和知情同意感兴趣,我在大学教授了很长一段时间。Covid-19流行病真的表现出我们的工作有多重要以及临床研究如何真正影响每个人的生命。这让我觉得自己是有原因选择这个使命。“


这篇文章只介绍了40多人中的一小部分人,他们不知疲倦地工作,在短短14天内将最初的提案加速交付给第一个试验参与者。该团队体现了我们工作的积极目标和我们对改善健康和改善生活的使命的奉献精神。随着COVID-19试验和其他项目的进展,我们将继续强调我们的人员及其在帮助推进检测、疫苗和新疗法方面的重要作用,这些将在对抗COVID-19的斗争中发挥重要作用。

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