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Functional Service Provider Model: Covance FSPx

我们的功能服务提供商型号（FSPX）提供了灵活和可扩展的功能，临床，技术和实验室服务的定制全球解决方案。

FSPx Covance Logo

Following the 2017 acquisition of Chiltern, Covance FSPx boasts one of the world’s largest dedicated FSP groups in the contract research organization (CRO) space with ~4,600+ staff in 60+ countries.

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Data Management

超过750强，董事会全球临床数据经理团队由平均15年的职业专业人士组成，在行业和10年以上的景气。它们都有医学或生物科学的背景，以及处理当地，区域或全球审判的数据需求。

The FSPx Data Management group has extensive experience across all major therapeutic areas, as well as:

  • Electronic case report forms (eCRF) development
  • Database builds
  • 实验室哒ta set-up processing and reconciliation
  • Data entry, query management, review, coding and SAE reconciliation
  • Timely database lock and final transfer

Despite being system agnostic, Covance FSPx has worked with Electronic Data Capture (EDC) systems since 1997 and is partnered with the industry’s best platforms.

生物统计学与规划

Covance has 700+ SAS®programmers with an average of 10 years of drug, device or biologics development expertise. We have been providing quality statistical services to clients for more than 30 years. Our globally harmonized SAS environment and processes ensures 24/7 continuity and resourcing models to offer efficiencies across your portfolio.

FSPx Statistical Analysis and Research Center (SARC) works across projects to provide guidance in clinical trial design, simulations, statistical methodology and Data Safety Monitoring Committee (DSMB) support.

标准

Covance has a rich history of successful SAS®dataset conversions and integration. Our Biostatistics / Statistical Programming group has converted many datasets for legacy studies, Integrated Summary of Safety / Integrated Summary of Efficacy (ISS/ISEs) and warehousing purposes. We have harmonized databases both on ISS and ISE levels, as well as conversions to internal customer defined legacy system specifications. We also have created customized SDTM training, implementation guides and consultancy services.

Covance FSPX已参与帮助客户自2004年以来实施CDISC标准。我们的临床分析团队是CDISC注册解决方案提供商和铂金成员。我们提供有或没有分析的咨询，数据转换和数据仓库服务。Covance已创建定制的CDISC ADAM和STDM培训和咨询服务，其中包括协助客户在创建自己对CDISC标准的解释方面。我们已经提供了超过80个演示文稿，并在PHUSE，CDISC互换和各种SUGS上全球捐赠了13个海报。此外，COVANCE是我们对亚当标准的贡献的CDISC的优秀表演者奖的三次接受者。

eClinical.

Platform Agnostic

我们选择的技术和分析工具是在平台不可知论的前提下，使我们能够将前沿技术应用于以下内容：

  • A strong design and programmatic interface including features to support team development and allow reuse of common components
  • An IT infrastructure and server environment that provides enterprise-level deployment options such as security, access control and user management, and high-performance data processing.

Covance FSPx has worked with more than 20 EDC vendors, and currently has EDC system knowledge transfer agreements with MedNet (iMedNet), Merge (eCOS), Medidata (Rave) and Oracle (Inform). Covance proposes partnering with an optimal EDC vendor, one which can provide industry-leading technological expertise, a high level of customer support and a cost-effective and user-friendly data collection system.

作为临床分析技术的行业领导者，Covance FSPX战略集成了独立的分析工具，如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
  • Xcellate.
  • Endpoint
  • Argus8 (Cloud)
  • SaaS Solutions
    • 测试数据模拟器TDS
    • 萨®酒店
    • Progtrak.

As a clinical service provider, Covance has been engaged in global, scalable Functional Service Provider (FSP) relationships with biopharmaceutical clients for 30 years in 57 countries across a number of functions, including clinical monitoring, drug safety, regulatory and clinical trial management. These engagements range in size from a few dedicated full time equivalent (FTE) staff to 150+ FTEs across several functional areas. Project-managed by you, employed by Covance and everything in between – we provide staff for the following job functions:

  • Clinical Research Associates (CRAs)
  • Project Managers
  • Program Leaders
  • Data Managers
  • Data Coordinators & Programmers
  • Medical Writers
  • 法规Staff
  • Biostatisticians
  • Clinical Trial Leads (CTLs)
  • 临床试验管理人员（CTMS）

This resource menu enables you to quickly ramp up or down your staffing levels, optimizing cost distribution without focusing your precious time on recruitment and retention.

Covance continually invests in attracting and retaining the right talent, with an emphasis on cultural fit and business continuity. We successfully on-boarded more than 500 new staff in 2017, and our retention rates are well above the industry average.

Our track record of consistent delivery of flexible resources and functional services gives our clients confidence – resulting in productive relationships that can last a decade or more. We invest in building, training and retaining our workforce on your behalf, with a focus on innovation, flexibility and cost competitiveness. We implement rigorous and visible Key Performance Indicators (KPIs) as core components of our quality control metrics.

Embedded Employee:
Input-based model		 Enhanced FTE:
Input-based model		 Unit Deliverable:
Output-based model
  • Sponsor retains overall accountability, responsibility and direction of the study including provision of direct management and work assignments to the assigned resources.
  • Sponsor retains overall accountability, responsibility and direction of the study while Covance is responsible for liaising with the sponsor and making work assignments directly with the assigned resources.
  • Covance管理日常任务和分配的资源。我们留下责任与招聘和介绍员工雇用的决定，他们将从Cocance办公室工作或基于现场的雇员。分配的工作人员可以使用我们的工具和系统或赞助商。

Covance FSPx delivers customized global solutions that enable you to manage your clinical operations and clinical trials with greater efficiency and flexibility. We deliver quality people, intelligent process and deep technical expertise with an emphasis on performance measurement and accountability.

Looking for opportunities to grow your FSPx career?Search our job opportunities here.

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