NEW YORK, Feb. 1, 2024 /PRNewswire/ -- Lindus Health, an 'anti-CRO' running radically faster, more reliable clinical trials for life science pioneers, announced the launch of its unified technology, site services and CRO services package for digital therapeutics (DTx) and digital health trials. This will enable sponsors to run radically faster, higher quality studies for regulatory approvals and payor access..

纽约，2024年2月1日/PRNewswire/--Lindus Health是一家为生命科学先驱进行速度更快、更可靠的临床试验的“反CRO”，它宣布推出其数字治疗（DTx）和数字健康试验的统一技术、网站服务和CRO服务包。这将使赞助商能够更快、更高质量地进行监管批准和付款人访问的研究。。

Lindus Health's new offering for the DTx market bundles the services of an experienced CRO in DTx. This includes a unique virtual/hybrid site offering, all underpinned by Lindus' internal Citrus clinical trial software built to run any DTx study from startup and recruitment to data delivery. Lindus has proven success in executing trials within this domain, having run 17 DTx studies in 12 disease indications across the US, UK, and EU and enrolling over 3,000 patients.

林德斯健康（Lindus Health）针对DTx市场的新产品捆绑了DTx领域经验丰富的CRO的服务。这包括一个独特的虚拟/混合网站产品，所有这些都得到了林德斯内部柑橘临床试验软件的支持，该软件旨在运行从启动和招聘到数据交付的任何DTx研究。Lindus已证明在该领域的试验取得了成功，在美国，英国和欧盟的12种疾病适应症中进行了17项DTx研究，并招募了3000多名患者。

This offering is intended to produce a true 'one-stop-shop' experience for everything needed to run a DTx clinical trial. Available now, this one-of-a-kind bundle of eClinical software, site capabilities, and CRO services empowers DTx sponsors to accelerate their clinical trials as a result of the following features:.

此产品旨在为运行DTx临床试验所需的一切提供真正的“一站式”体验。目前，这一独一无二的电子临床软件、站点功能和CRO服务包已面世，它使DTx赞助商能够通过以下功能加速其临床试验：。

CRO services for end-to-end execution: Lindus Health are experts in the DTx space, having run a multitude of these studies across many countries. They offer a full suite of study execution services at every phase of digital therapeutics trials, including protocol development, ethics committee submissions, patient recruitment, data management, safety reporting, and more, through a singular eClinical platform..

用于端到端执行的CRO服务：Lindus Health是DTx领域的专家，在许多国家进行了大量此类研究。他们通过一个单一的电子临床平台，在数字治疗试验的每个阶段提供全套研究执行服务，包括方案制定，伦理委员会提交，患者招募，数据管理，安全报告等。。

Technology-driven recruitment services: Lindus Health employs a variety of different strategies to accelerate DTx trials. With access to over 30 million electronic health records (EHRs) and an in-house digital marketing team to execute multi-channel recruitment campaigns, Lindus Health has proven success in screening and enrolling thousands of patients for DTx studies faster than traditional CROs..

技术驱动的招聘服务：Lindus Health采用各种不同的策略来加速DTx试验。Lindus health拥有3000多万份电子健康记录（EHR）和一个内部数字营销团队来执行多渠道招聘活动，事实证明，与传统的CRO相比，Lindus health在筛选和招募数千名患者进行DTx研究方面取得了成功。。

Clinical site services: From single- to multi-site studies, and traditional to virtual or hybrid sites, Lindus Health's internal site operations team is staffed to execute DTx studies from top to bottom. This includes engaging with highly experienced principal investigators (PIs) in DTx, Clinical Research Coordinators (CRCs), and other site personnel to manage any administrative, protocol-related, or miscellaneous activities to ensure seamless trial execution at the site level..

临床站点服务：从单站点研究到多站点研究，从传统站点到虚拟站点或混合站点，Lindus Health的内部站点运营团队配备了从上到下执行DTx研究的人员。这包括与DTx中经验丰富的主要研究人员（PI），临床研究协调员（CRC）和其他现场人员合作，管理任何行政，协议相关或杂项活动，以确保现场层面的无缝试验执行。。

Citrus Complete eClinical Platform: Internally developed eClinical platform including EDC, CTMS, data collection, and site management tool with tested experience in collecting and delivering data for DTx studies in CDISC SDTM format at the click of a button.

Citrus Complete电子临床平台：内部开发的电子临床平台，包括EDC，CTMS，数据收集和站点管理工具，在收集和交付CDISC SDTM格式的DTx研究数据方面具有测试经验，只需点击按钮。

Deep expertise in DTx and medical device regulatory pathways: Lindus Health's clinical operations team has experience running 17 trials involving digital therapeutic products within 12 therapeutic locations, including multiple trials for FDA 510 (k) and De-Novo submissions.

在DTx和医疗器械监管途径方面拥有丰富的专业知识：Lindus Health的临床运营团队在12个治疗地点进行了17项涉及数字治疗产品的试验，包括针对FDA 510（k）的多项试验和从头提交的试验。

Collaborating with the right CRO backed by extensive experience in DTx studies is crucial for the success of these trials, as there are a number of considerations unique to conducting a DTx trial. Lindus Health's all-encompassing digital therapeutics offering avoids the need for sponsors to worry about responsibilities such as selecting vendors for various trial management technologies and identifying and engaging with sites for participation.

与正确的CRO合作，并获得DTx研究的丰富经验，对于这些试验的成功至关重要，因为进行DTx试验有许多独特的考虑因素。林德斯健康（Lindus Health）的全方位数字治疗产品避免了赞助商需要担心的责任，例如为各种试验管理技术选择供应商，以及确定和参与网站。

The company's eClinical software includes the full package of tools to run a clinical trial. The impact is harmonious data access between the electronic data capture (EDC), clinical trial management system (CTMS), visit scheduling, data collection tools (eConsent, ePRO, etc.) and more. This unified technology offering coupled with a full-suite of DTx specific CRO services sets DTx sponsors up for success when launching and conducting trials for their innovative and potentially life-changing therapies..

该公司的电子临床软件包括用于运行临床试验的全套工具。其影响是电子数据采集（EDC），临床试验管理系统（CTMS），访问计划，数据收集工具（eConsent，ePRO等）等之间的和谐数据访问。这种统一的技术产品，加上全套DTx特定的CRO服务，使DTx赞助商在启动和进行创新性和潜在改变生命的疗法的试验时取得了成功。。

Lindus Health has established themselves as highly reputable in accelerating the development of digital therapeutics. With the support of DTx advisors such as Acacia Parks and their partnership with the Digital Therapeutics Alliance (DTA), the company stands out as an innovative and experienced CRO within this market segment.

Lindus Health在加速数字疗法的发展方面享有盛誉。在Acacia Parks等DTx顾问的支持以及他们与数字治疗联盟（DTA）的合作下，该公司在这一细分市场中脱颖而出，成为一名创新且经验丰富的CRO。

The company has enrolled more than 6,000 patients across over 90 clinical trials to date, with a significant proportion within the DTx domain. These trials have tested DTx interventions for a wide range of indications such as diabetes, social anxiety, myopia, tinnitus, and more..

迄今为止，该公司已在90多项临床试验中招募了6000多名患者，其中很大一部分在DTx领域。这些试验测试了DTx干预措施的广泛适应症，如糖尿病、社交焦虑、近视、耳鸣等。。

Anthony Brogno, Director of Clinical Operations at Lindus Health, said: 'Our new offering for the DTx market will eliminate the guesswork and hurdles sponsors in this space face head-on when trying to run their own clinical studies. It's exciting to be able to leverage all our experience in the DTx space and deliver that as an efficient DTx specific CRO operation that includes software, site, and CRO services package that aims to deliver DTx studies faster and more efficiently in hopes of getting these innovative treatments to market..

林德斯健康（Lindus Health）临床运营总监安东尼·布罗尼奥（AnthonyBrogno）表示：“我们为DTx市场提供的新产品将消除赞助商在进行自己的临床研究时面临的猜测和障碍。很高兴能够利用我们在DTx领域的所有经验，并将其作为一种高效的DTx特定CRO操作进行交付，该操作包括软件、站点和CRO服务包，旨在更快、更有效地交付DTx研究，以期将这些创新疗法推向市场。。

Digital therapeutics are evidence-based software interventions designed to prevent, manage, or treat various medical disorders and diseases. These therapies can be utilized through mobile applications, wearables, or online platforms to manage and treat a wide array of chronic conditions and can be used in complement to or in lieu of pharmaceutical medications and medical devices..

数字疗法是基于证据的软件干预措施，旨在预防，管理或治疗各种医学疾病和疾病。这些疗法可以通过移动应用程序、可穿戴设备或在线平台来管理和治疗各种慢性病，可以补充或替代药物和医疗设备。。

Lindus Health's 'All-In-One CRO' offering enables DTx companies to achieve study milestones faster through their tech-forward and patient-centric approach to executing clinical trials.

林德斯健康（Lindus Health）的“一体式CRO”服务使DTx公司能够通过其技术进步和以患者为中心的临床试验方法更快地实现研究里程碑。

To learn more about Lindus Health's offering for the DTx market, click here.

要了解林德斯健康为DTx市场提供的更多信息，请单击此处。

About Lindus HealthLindus Health is an anti-CRO running radically faster and more reliable trials for life science pioneers – bringing ground-breaking treatments to patients more quickly. Lindus Health does this thanks to a commercial model that aligns incentives (fixed-priced quotes per study, with milestone-based payments), marrying a world-class clinical operations team with its unique software platform, and access to 30 million Electronic Health Records.

关于Lindus Health Lindus Health是一家反CRO的公司，为生命科学先驱进行了速度更快、更可靠的试验，为患者带来了突破性的治疗。林德斯健康（Lindus Health）之所以能够做到这一点，得益于一种商业模式，该模式将激励措施（每项研究的固定价格报价，以及基于里程碑的付款）与世界一流的临床运营团队及其独特的软件平台结合在一起，并可以访问3000万份电子健康记录。

Clinical trials are the biggest bottleneck to advances in healthcare and by removing this constraint they aim to improve health for everyone. They handle the end-to-end execution of clinical studies, including design, patient recruitment, clinical data capture, monitoring and project management..

临床试验是医疗保健进步的最大瓶颈，通过消除这一限制，他们旨在改善每个人的健康。他们负责临床研究的端到端执行，包括设计、患者招募、临床数据采集、监测和项目管理。。

Media ContactJodi PerkinsAmendola for Lindus Health[email protected]

Lindus Health的媒体联系人Jodi PerkinsAmendola[受电子邮件保护]

SOURCE Lindus Health

来源Lindus Health