Functional Service Provision (FSP)

Covance FSPx offers customized global solutions of functional, clinical, technical and laboratory services that are flexible and scalable.

Following the 2017 acquisition of Chiltern, Covance FSPx boasts one of the world’s largest dedicated FSP groups in the contract research organization space with ~4,200+ staff in 60+ countries.

Covance Clinical Analytics is supported by a global team of 2300+ full-time, highly educated and technically skilled staff. The clinical analytics group has experience providing functionally outsourced clinical and laboratory data management, biostatistics and statistical programming services to the biopharmaceutical industry.  Our partnerships with leading edge technology providers offers an unparalleled eClinical suite. While blending the best of BPOs and CROs, the clinical analytics team is solely focused on clinical trials.

Functional Service Provision at Covance consists of two major groups:

FSPx Covance Logo
Covance FSP map
clinical analytics, clinical operations, FSPX total

FSPx Clinical Analytics

Data Management

More than 750 strong, the Covance global team of clinical data managers is made up of tenured professionals with an average of 15 years in the industry and 10+ years with Covance.  They all have a background in medicine or biological sciences and in handling data needs for local, regional or global trials.

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

  • 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

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.

Biostatistics & Programming

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.

Standards

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 has been involved with helping clients implement CDISC standards since 2004.  Our clinical analytics team is a CDISC Registered Solutions Provider and Platinum member.  We offer services in consulting, data conversions and data warehousing with or without analytics.  Covance has created customized CDISC ADaM and STDM training and consultancy services, which has 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, Covance is a three-time recipient of the Outstanding Performer award from CDISC for our contributions toward the ADaM standards.

eClinical

Platform Agnostic

Our choice of technology and analytics tools is founded on the premise of platform agnosticism, enabling us to apply leading edge technology to the following:

  • 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.

As an industry leader in clinical analytics technology, Covance FSPx 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
  • Argus8 (Cloud)
  • SaaS Solutions
    • Test Data Simulator TDS
    • SAS® Hotel
    • ProgTrak

FSPx Clinical Operations

Covance has been engaged in global, scalable Functional Service Provision (FSP) relationships with biopharmaceutical clients for 30 years in 57 countries across a number of functions, including clinical monitoring, drug safety, regulatory and study 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
  • Regulatory Staff
  • Biostatisticians
  • Clinical Trial Leads (CTLs)
  • Clinical Trial Managers (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.

FSP can include several different delivery models

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 manages the day-to-day tasks and the resources assigned. We retain responsibility for decisions concerned with hiring and line management of our employees who will work from Covance offices or who are field-based. The staff members assigned can use our tools and systems or those of the Sponsor.

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