Covance Is Now Labcorp Drug Development

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Dedicated outsourcing 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 outsourcing 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 functional service provider (FSP) groups in the contract research organization (CRO) space. Count on an outsourced team of resources of ~7,200+ employees across 60+ countries to help advance your mission.

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

We Believe in Harnessing Technology for Human Good

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

FSPx Clinical Analytics

  • Data Management

    Move your program forward by partnering with experts from our Clinical Data Solutions team of 1600+ 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:

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

     

    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.

  • Biostatistics & Programming

    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).

  • Standards

    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. We have harmonized databases both on ISS and ISE levels, as well as conversions to internal customer defined legacy system specifications. 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. We have given more than 80 presentations and contributed to 13 posters globally on CDISC topics at PhUSE, CDISC Interchanges and various SUGs. In addition, Labcorp is a three-time recipient of the Outstanding Performer award from CDISC for our contributions toward the ADaM standards.

  • 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
    • 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.

    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 Solutions

FSPx Clinical Operations

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:

  • Clinical Research Associates (CRAs)
  • Project Managers
  • Program Leaders
  • Data Managers
  • Data Coordinators and Programmers
  • Medical Writers
  • Regulatory Staff
  • Biostatisticians
  • Clinical Trial Leads (CTLs)
  • Clinical Trial Managers (CTMs)

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 

 
Embedded Employee:
Input-based model
Enhanced FTE:
Input-based model
Unit Deliverable:
Output-based model

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. We retain responsibility for decisions concerned with hiring and line management of our employees who will work from Labcorp offices or who are field-based. 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.

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

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