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CIBMTR®启动快速临床位点选择和激活,加快细胞和基因治疗试验的注册

CIBMTR® Launches Rapid Clinical Site Selection and Activation, Resulting in Faster Trial Enrollment for Cell and Gene Therapy Trials

businesswire 等信源发布 2024-05-01 20:00

可切换为仅中文


MINNEAPOLIS--(BUSINESS WIRE)--NMDP BioTherapies announced today that CIBMTR CRO Services now offers a rapid clinical site selection and activation service, resulting in faster trial enrollment for cell and gene therapy (CGT) trials. By leveraging data from its 675,000+ patient clinical outcomes database, CIBMTR can quickly identify, vet and select transplant centers based on patient population, diversity and competing trials..

明尼阿波利斯--(商业新闻短讯)--NMDP BioTherapies今天宣布,CIBMTR CRO Services现在提供快速的临床站点选择和激活服务,从而加快了细胞和基因治疗(CGT)试验的试验注册。通过利用其675000多名患者临床结果数据库中的数据,CIBMTR可以根据患者人群,多样性和竞争性试验快速识别,审查和选择移植中心。。

“At hand-off to our dedicated site startup team, we leverage our deep relationships with transplant centers to get your CGT trial activated and enrolling quickly, which enables sponsors to reduce the time required to launch and execute high-impact clinical trials,” notes Erin Leckrone, Vice President, Clinical Trials.

临床试验副总裁艾琳·莱克龙(ErinLeckrone)指出:“在移交给我们专门的网站启动团队时,我们利用与移植中心的深厚关系,让您的CGT试验快速启动和注册,这使赞助商能够减少启动和执行高影响力临床试验所需的时间。”。

“In addition, expert CIBMTR physician review enables endpoint efficiencies and mitigates barriers, allowing a refined protocol to progress more quickly through IRB, DSMB and regulatory body approvals.”.

“此外,专家CIBMTR医师审查可以提高终点效率并缓解障碍,从而通过IRB,DSMB和监管机构的批准,可以更快地改进协议。”。

CIBMTR CRO Services’ team of clinical trial experts will be sharing their insights, experiences and strategies aimed at accelerating trial implementation and execution through two presentations, (i) fostering a clinical research associate (CRA) culture of excellence and (ii) critical data oversight structures at the upcoming Association of Clinical Research Professionals (ACRP) 2024 Annual Meeting..

CIBMTR CRO Services的临床试验专家团队将通过两次演讲分享他们的见解、经验和策略,旨在加速试验的实施和执行,(i)培养临床研究助理(CRA)的卓越文化,以及(ii)即将举行的临床研究专业人员协会(ACRP)2024年年会上的关键数据监督结构。。

Here's a glimpse of what attendees can expect:

以下是与会者的期望:

Title: A CRO Training Program for Overcoming Workforce Development Roadblocks

标题:克服劳动力发展障碍的CRO培训计划

Presenters: Kathleen Kane, Alisha Mussetter, Kassandra Nealon

主持人:凯瑟琳·凯恩、艾丽莎·穆塞特、卡桑德拉·尼隆

Date & Time: Monday, May 6, 2024, 10:30-11:30 a.m. PT

日期和时间:2024年5月6日星期一上午10:30-11:30 PT

Content: This session offers actionable strategies for enhancing clinical research training programs, drawing from the success of a CRA training program implemented by a small contract research organization. Attendees will learn how to foster a culture of excellence and growth within their teams.

内容:本课程借鉴了一家小型合同研究组织实施的CRA培训计划的成功经验,为加强临床研究培训计划提供了可行的策略。与会者将学习如何在团队中培养卓越和成长的文化。

Title: Understanding Roles & Responsibilities in a World of Increasing Data Complexity

标题:了解在数据日益复杂的世界中的角色和责任

Presenter: Kathleen Kane

主持人:凯瑟琳·凯恩

Date & Time: Sunday, May 5, 2024, 10:15-11:15 a.m. PT

日期和时间:2024年5月5日星期日上午10:15-11:15 PT

Content: In an era marked by increasing data complexity, this session explores foundational data oversight concepts crucial for successful clinical investigations. Kathleen will discuss the importance of clearly defining roles and responsibilities across multidisciplinary stakeholders.

内容:在一个数据复杂性不断增加的时代,本课程探讨了对成功的临床研究至关重要的基础数据监督概念。Kathleen将讨论明确定义跨多学科利益相关者的角色和责任的重要性。

CIBMTR CRO Services are a collaborative effort between NMDP BioTherapies and the CIBMTR, resulting in unique expertise and access to unparalleled resources, including research, sites, donors, partnerships and scientific and operational expertise.

CIBMTR CRO服务是NMDP BioTherapies和CIBMTR之间的合作努力,产生了独特的专业知识,并获得了无与伦比的资源,包括研究,地点,捐助者,合作伙伴关系以及科学和运营专业知识。

About NMDP BioTherapies

关于NMDP生物疗法

NMDP BioTherapies is the only cell and gene therapy solutions provider with customizable services to support the end-to-end cell therapy supply chain. Backed by the industry-leading experience of NMDP℠ and a research partnership with the CIBMTR® (Center for International Blood and Marrow Transplant Research®), the organization designs solutions that advance the development of cell and gene therapies across the globe..

NMDP BioTherapies是唯一一家提供可定制服务以支持端到端细胞治疗供应链的细胞和基因治疗解决方案提供商。凭借NMDP行业领先的经验℠ 以及与CIBMTR®(国际血液和骨髓移植研究中心®)的研究伙伴关系,该组织设计了促进全球细胞和基因疗法发展的解决方案。。

NMDP BioTherapies is dedicated to accelerating patient access to life-saving cell and gene therapies by providing high-quality cellular source material from the NMDP Registry℠, the world’s most diverse registry of more than 7 million potential blood stem cell donors. Through established relationships with apheresis, marrow collection, and transplant centers worldwide, the organization develops, onboards, trains, and manages expansive collection networks to advance cell therapies.

NMDP生物疗法致力于通过从NMDP登记处提供高质量的细胞源材料,加速患者获得挽救生命的细胞和基因疗法℠, 世界上最多样化的登记处,有700多万潜在的造血干细胞捐献者。通过与世界各地的单采血液、骨髓采集和移植中心建立关系,该组织开发、部署、培训和管理广泛的采集网络,以推进细胞疗法。

NMDP BioTherapies uses a proven infrastructure consisting of regulatory compliance and managed logistics experts and cell therapy supply chain case managers to successfully transport and deliver regulatory-compliant life-saving therapies across the globe. Through the CIBMTR, NMDP BioTherapies extends services beyond the cell therapy supply chain to include long-term follow-up tracking for FDA-approved CAR-T therapies..

NMDP BioTherapies使用由法规遵从性和管理物流专家以及细胞治疗供应链案例管理人员组成的经验证的基础设施,在全球范围内成功运输和提供符合法规的救生疗法。通过CIBMTR,NMDP BioTherapies将服务扩展到细胞疗法供应链之外,包括对FDA批准的CAR-T疗法进行长期随访。。

For more information, follow NMDP BioTherapies on LinkedIn or Twitter.

有关更多信息,请在LinkedIn或Twitter上关注NMDP生物疗法。

About the CIBMTR

关于CIBMTR

The CIBMTR® (Center for International Blood and Marrow Transplant Research®) is a research collaboration between NMDP℠ and the Medical College of Wisconsin (MCW). The CIBMTR collaborates with the global scientific community to advance hematopoietic cell transplantation (HCT) and cellular therapy worldwide to increase survival and enrich quality of life for patients.

CIBMTR®(国际血液和骨髓移植研究中心®)是NMDP之间的研究合作℠ 和威斯康星医学院(MCW)。CIBMTR与全球科学界合作,在全球范围内推进造血细胞移植(HCT)和细胞治疗,以提高患者的生存率和生活质量。

The CIBMTR facilitates critical observational and interventional research through scientific and statistical expertise, a network of more than 300 transplant centers, and one of the largest databases worldwide for clinical outcomes of cellular therapy, and a biorepository with tissue samples..

CIBMTR通过科学和统计专业知识、300多个移植中心的网络、全球最大的细胞治疗临床结果数据库之一以及组织样本生物储存库,促进了关键的观察性和介入性研究。。

For more information on the CIBMTR, please visit www.cibmtr.org or follow the CIBMTR on Facebook, LinkedIn, or Twitter.

有关CIBMTR的更多信息,请访问www.CIBMTR.org或在Facebook、LinkedIn或Twitter上关注CIBMTR。

About the Medical College of Wisconsin

关于威斯康星医学院

The Medical College of Wisconsin brings together the most inquisitive minds in science, medicine, education and community engagement to solve the toughest challenges in health and society today. Academic medicine is at the core, where scientists, physicians and students work together with the community to ask the questions no one else is and fuel the continuous cycle of knowledge that’s shaping the future or medicine..

威斯康星州医学院汇集了科学、医学、教育和社区参与领域最具好奇心的人才,以解决当今健康和社会面临的最严峻挑战。学术医学是核心,科学家、医生和学生与社区合作,提出其他人不知道的问题,并推动塑造未来或医学的知识不断循环。。

For more information, visit www.mcw.edu or follow the Medical College of Wisconsin on Facebook, LinkedIn, and Twitter.

有关更多信息,请访问www.mcw.edu或在Facebook、LinkedIn和Twitter上关注威斯康星医学院。