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精鼎医药宣布与瑞金海南医院建立创新型合作伙伴关系

2024-06-04

双方战略合作伙伴关系利用真实世界数据和真实世界证据加速将创新疗法带给中国患者


精鼎医药于近日宣布,公司已与上海交通大学医学院附属瑞金医院海南医院(海南博鳌研究型医院)(以下简称瑞金海南医院)达成战略合作,双方将探索使用真实世界数据(RWD)和真实世界证据(RWE)推动药物的加速审批,提升中国患者对创新药物和疗法的可及性。借助与瑞金海南医院的合作,精鼎医药将有机会支持客户加速产品在中国的市场准入,让患者早日获得他们治疗最需要的产品。

精鼎医药公司副总裁,真实世界证据亚太地区负责人冯胜表示:“精鼎医药与瑞金海南医院将携手利用海南真实世界审批路径加快新药上市,最终为患者提供他们原来可能无法快速获得的创新疗法。我们很高兴能与瑞金海南医院合作为中国市场带来创新的解决方案。瑞金海南医院是一家以卓越的患者护理和医学研究闻名的中国顶级医疗机构。精鼎医药的全球业务布局加上瑞金海南医院在医学和RWD/E领域的专业能力将让我们有能力更好地推动新药在中国的开发。”

海南真实世界证据审批路径支持企业将RWD/E用于药品和医疗器械在中国的上市注册。这一审批路径可帮助药物开发者缩短创新医疗产品的上市时间,解决中国市场未被满足的医疗需求。

与瑞金海南医院的合作将为精鼎医药带来有关中国医药健康市场的宝贵洞见,从而帮助其全球生物制药客户更高效地应对中国市场的格局变化。


关于精鼎医药

作为全球知名的合同研究组织(CRO)之一,精鼎医药致力于为客户提供一站式的I至IV期临床开发服务,以期将拯救生命的疗法更快带给患者。凭借在临床、法规和治疗领域所积累的专业能力,我们全球21,000多名专业人才团队与生物制药行业的领导者、新兴创新公司和临床研究中心建立了广泛合作;并在“以患者为中心”理念的指引下帮助客户设计和交付临床试验,提升临床研究的可及性和患者参与度,致力于使临床试验成为世界各地更多患者的治疗选择。我们在过去40年中所积累的丰富行业知识以及获得的良好业绩让我们得以不断推动整个行业向前发展,并将临床研究推向医疗行业复杂领域。与此同时,我们的创新生态系统还为临床研究各阶段效率的提升提供了更优的解决方案。我们拥有一流的专业人才、深厚的行业洞察以及卓越的运营能力;我们的使命是用心工作每一天,尊重患者,并不断地从他们的经验中学习,从而让每一个临床研究都能为患者带来有意义的改变。精鼎医药的价值观和所取得的成就使其斩获了行业颁发的多个奖项和荣誉。2023年11月,精鼎医药被Citeline任命的评委小组评选为“最佳合同研究组织”;在此之前, 精鼎医药还获得了2023年WCG CenterWatch 全球研究中心关系调研评选的 "最值得合作的CRO”称号,以及临床研究中心协会(SCRS)颁发的2023年度鹰奖,以表彰公司在与研究单位构建积极关系推动临床研究行业发展方面所取得的成就。



Parexel Announces Innovative Collaboration with Ruijin Hainan Hospital

Strategic partnership leverages real world data and real world evidence to provide patients accelerated access to new treatments in China


Parexel, one of the world's largest clinical research organizations (CROs) providing the full range of Phase I to IV clinical development services, today announced a strategic partnership with Ruijin – Hainan Hospital Shanghai Jiao Tong University School of Medicine Hainan Boao Research Hospital (Ruijin Hainan Hospital) to leverage real world data (RWD) and real world evidence (RWE) to accelerate drug approvals and facilitate drug access for patients in China. By collaborating with Ruijin Hainan Hospital, Parexel will provide biopharmaceutical customers with an opportunity to gain early access into the Chinese market and support the expedited delivery of vital medicines to patients in need. 

"This strategic partnership leverages the Hainan Real World Evidence Pathway program to speed the time to market for new medical products, ultimately providing patients with access to innovative treatment options that might not otherwise be available," said Sheng Feng, Corporate Vice President, Real World Evidence, Asia/Pacific. "We are excited to collaborate with Ruijin Hainan Hospital, a premier healthcare institution known for its excellence in patient care and medical research, to bring innovative solutions to the Chinese market. By combining Parexel's global reach and unparalleled experience with Ruijin Hainan Hospital's medical expertise and access to RWD/E, we believe we are well-positioned to advance drug development in China."

The Hainan Real World Evidence Pathway program is designed to utilize RWD/E to support clinical development of medical products in China. By leveraging this regulatory pathway, drug developers can introduce novel, innovative medical products to patients sooner, addressing unmet medical needs in the Chinese market. 

The collaboration with Ruijin Hainan Hospital provides Parexel with invaluable insights to enhance the Company's ability to navigate the rapidly evolving Chinese healthcare landscape efficiently on behalf of its global biopharmaceutical customers.


About Parexel

Parexel is among the world's largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals works in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare's most complex areas, while our innovation ecosystem offers quality solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. This approach continues to earn us recognition industrywide, with Parexel being named "Best Contract Research Organization" in November 2023 by an independent panel for Citeline, "Top CRO to Work With" by investigative sites worldwide in the 2023 WCG CenterWatch Global Site Relationship Benchmark Survey and recipient of the 2023 Society for Clinical Research Sites (SCRS) Eagle Award for advancing the clinical research profession through strong site partnerships. For more information, visit parexel.com and follow us on LinkedIn, Twitter, Facebook and Instagram.