Covance Is Now Labcorp Drug Development

作为一家全球性公司,我们致力于为千百万人的福祉共同创新,持续为您带来更先进的医学突破。

Dedicated support at any point in your clinical trial journey

Functional Service Provider Model (FSPx®)

Gain access to customized global solutions of functional, clinical, technical and laboratory services–flexible and scalable for your evolving needs.

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Whether you need to extend your clinical data teams or clinical operations staff, we offer one of the world's largest dedicated FSP groups in the contract research organization (CRO) space. Count on our resources of ~6,000+ employees across 60+ countries to help advance your mission.

功能性服务供应商地图

We Believe in Harnessing Technology for Human Good

Maximize the value of your clinical data with our FSPx Clinical Data Solutions

We help deliver quicker insights from data acquisition through to analytics, so you can focus on advancing life-changing therapies.

FSPx临床分析

  • 数据管理

    Move your program forward by partnering with experts from our Clinical Data Solutions team of 2,300+ clinical data managers. Our tenured professionals know how to advance your data-driven solutions, drawing on their 15-year average of industry experience and more than 10 years supporting sponsors through Labcorp FSPx.

    Whether you need to advance local, regional or global trials, rely on our specialists’ focused backgrounds—spanning medicine and biological sciences—to help you make strategic decisions that can lead to better outcomes.

    Our FSPx Data Management group can apply their insights across all major therapeutic areas and deliver expertise in:

    • 电子个案报告表(eCRF)制订
    • 数据库建立
    • 实验室数据设置处理与协调
    • 数据输入、查询管理、审查、编码和SAE协调
    • 数据库及时锁定和最终传输

     

    Innovative data management helps to ensure integrity, quality and accountability in your process. We offer system agnostic support and can also draw on our experience supporting Electronic Data Capture (EDC) systems since 1997, along with the industry's best platforms. Together, we can find the answers that help you develop transformative drugs with speed.

  • 生物统计学和编程

    Get appropriate interpretation of your study results and create efficiencies across your portfolio with our team of 700+ SAS® programmers and biostatisticians. Averaging 10 years of drug, device or biologics development expertise, our team knows how to deliver customized, quality statistical services across every aspect of drug development.

    Trust in our 30 years of experience to advance your harmonized SAS environment and provide 24/7 continuity across a global infrastructure.

    Our comprehensive data management solutions also include our FSPx Statistical Analysis and Research Center (SARC), which works across your projects to provide guidance in clinical trial design, simulations, statistical methodology–as well as support your Data Safety Monitoring Board (DSMB).

  • 标准

    Enhance your operational effectiveness with our proven success in SAS® dataset conversions and integration. Our Biostatistics / Statistical Programming team has converted many datasets for legacy studies, Integrated Summary of Safety / Integrated Summary of Efficacy (ISS/ISEs) and warehousing purposes. 我们拥有ISS和ISE级别的协调数据库,并且向内部客户定义的传统系统规格进行过转换。 Our clients also benefit from customized SDTM training creation, implementation guides and consultancy services.

    As a CDISC Registered Solutions Provider and Platinum member, our clinical data solutions team at Labcorp FSPx knows how to generate compliant deliverables. Since 2004, we have helped clients implement CDISC standards. Our integrated services include consulting, data conversions and data warehousing-with or without analytics.

    When it comes to data standards, we are always learning. Labcorp has created customized CDISC ADaM and STDM training and consultancy services, which have included assisting clients in the creation of their own interpretations of CDISC standards. 我们在全球范围内的PhUSE、CDISC相互交流和各种SUG上就CDISC主题发表了超过80次报告和13张海报。此外,由于对ADaM标准的突出贡献,Labcorp三次荣获CDISC颁发的“杰出表现奖”。

  • eClinical

    Platform-Agnostic Solutions for your Studies

    Our strength lies in platform agnosticism and our analytics capabilities enable us to apply leading-edge technology that can deliver:

    • A strong design and programmatic interface—including features to support team development and allow reuse of common components
    • 提供企业级部署选项(如安全性、访问控制和用户管理以及高性能数据处理)的IT基础设施和服务器环境

    Working with more than 20 EDC vendors, our team at Labcorp FSPx can leverage our EDC system knowledge transfer agreements with Mednet (iMednet), Merge (eCOS), Medidata (Rave) and Oracle (InForm). We work alongside your team to partner with an optimal EDC vendor, one that can provide industry-leading technological expertise, a high level of customer support and a cost-effective, user-friendly data collection system.

    As an industry leader in clinical data technology, our FSPx team also strategically integrates independent analytics tools, such as BOXI, JReview, SAS®, Cognos and Spotfire . Wielding these tools and rendering data in this capacity is an art form requiring well-established visual analytics principles, theories and a talented pool of programming individuals well-versed in the following platforms:

    • Spotfire®
    • Xcellerate®
    • Endpoint
    • ARGUS Cloud
    • SaaS解决方案

FSPx临床试验运营

Supplement your clinical operations program with an experienced partner at your side. As a clinical service provider, our team at Labcorp has been engaged in global, scalable Functional Service Provider (FSP) relationships with biopharmaceutical clients for more than 30 years across 60+ countries. We know how to serve as a vital extension of your resources across a number of functions-including clinical monitoring, drug safety, regulatory and clinical trial management-all aligned to your culture, mission and business goals.

Our engagements are customized to your needs-from a few dedicated full-time equivalent (FTE) staff to 150+ FTEs across several functional areas. Project-managed by you, employed by Labcorp-we provide the specialized staff you need for the following job functions:

  • 临床研究协会(CRA)
  • 项目经理
  • 项目负责人
  • 数据经理
  • Data Coordinators and Programmers
  • 医学作家
  • 法规人员
  • 生物数据统计员
  • 临床试验主管(CTL)
  • 临床试验经理(CTM)

With our resource menu at your disposal, you can quickly ramp up or down your staffing levels-without focusing on recruitment and retention-and optimize your cost distribution. We continually invest in attracting and retaining the right talent, working with people who can integrate into your teams and deliver seamless business continuity.

Our team is here to help deliver confidence to your team. By starting with consistent delivery of flexible resources and functional services, we believe in being more than a partner. In fact, we often foster long-term, productive relationships that last more than 10 years. Our focus is centered on your needs as we continue to invest in building, training and retaining our workforce on your behalf, with a focus on innovation, flexibility and cost competitiveness.

Throughout every interaction, we implement rigorous and visible Key Performance Indicators (KPIs) as core components of our quality control metrics to enable the transparency and accountability you need to move forward.

Tailor our FSP delivery model to your unique requirements 

嵌入式员工:
基于输入的模式
强化FTE:
基于输入的模式
单位交付:
基于输出的模式

You retain overall accountability, responsibility and direction of the study— including provision of direct management and work assignments to your assigned resources.

You retain overall accountability, responsibility and direction of the study, while our team at Labcorp is responsible for liaising with you and making work assignments directly with your assigned resources.

We manage the day-to-day tasks and the resources assigned to your program. 我们保留与雇用及直线管理在Labcorp办公室或现场工作的员工有关的决策责任。 The staff members assigned can use our tools and systems or yours.

We are here to manage your clinical operations and clinical trials with greater efficiency and flexibility. By linking quality people, intelligent process and deep technical expertise, we can deliver performance measurement and accountability, so you can focus on developing innovative therapies for patients.

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