LabCorp 2014 Annual Report Download - page 19

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Covance Drug Development’s capabilities provide clients the flexibility to conduct studies on a multinational and simultaneous
basis. The data it provides is combinable and results in global clinical trial reference ranges because it uses consistent laboratory
methods, identical reagents and calibrators, and similar equipment globally. Combinable data eliminates the cumbersome process
of statistically correlating results generated using different methods and different laboratories on different equipment.
Covance Drug Development also employs a proprietary clinical trials management system that enables it to enter a sponsor’s
protocol requirements directly into its database. The laboratory data can be audited because all laboratory data can be traced to
source documents. In addition, the laboratories are capable of delivering customized data electronically within 24 hours of test
completion. Covance Drug Development also offers pharmacogenomic testing and sample storage technologies in conjunction
with its central laboratory services. Central laboratory services also offers LabLink, an client access program that
allows clients to review and query clinical trial lab data on a near basis.
Covance Drug Development’s central laboratories have an automated kit production line that is located in the United States
and supplies kits to investigator sites around the world. This system allows the flexibility to expand kit production volume more
quickly and uses consistent methods to reduce supply variation for Covance Drug Development’s clients. An automated kit receipt
line was introduced in Covance Drug Development’s United States central laboratory in 2013.
Covance Drug Development has a biorepository facility in Greenfield, Indiana dedicated to storage
of clinical trial specimens. This facility is able to store a wide range of specimens, including plasma, serum, whole blood, DNA,
PBMC and tissue.
In 2013, Covance Drug Development commenced offering companion diagnostic services, which support the parallel
development of a new medicine and its companion diagnostic assay, and external laboratory management services, which help
clients select, qualify, contract with and manage outside laboratories.
Clinical Development Services
Covance Drug Development offers a comprehensive range of clinical trial services, including the full management of Phase II
through IV clinical studies. Covance Drug Development has extensive experience in all significant therapeutic areas, and it
provides the following core services either on an individual or aggregated basis to meet its clients’ needs: study design and
modeling; coordination of study activities; trial logistics; monitoring of study site performance; clinical data management and
biostatistical analysis; and medical writing and regulatory services.
Covance Drug Development has extensive experience in managing clinical trials in the North America, Europe, South America
and Asia Pacific regions. These trials may be conducted separately or simultaneously as part of a multinational development plan.
Covance can manage every aspect of clinical trials from clinical development plans and protocol design to New Drug Applications,
among other supporting services. Over the last several years, clinical development services have continued its expansion into
Eastern Europe, the Middle East, Asia Pacific and South America.
Covance Drug Development uses Xcellerate®, a proprietary methodology designed to help optimize clinical trial performance
to assist biopharmaceutical companies in improving quality, reducing waste, and decreasing trial timelines. The Xcellerate®
methodology enables on-site custom recommendations, investigator and geographic selection to enhance clinical trial design and
execution.
Covance Drug Development offers a range of periapproval services, which are studies conducted “around the time of New
Drug Application approval,” generally after a drug has successfully undergone clinical efficacy and safety testing and the New
Drug Application has been submitted to the FDA. These services include:
• Treatment Investigational New Drug applications;
• Phase IIIb clinical studies, which involve studies conducted after New Drug Application submission, but before regulatory
approval is obtained;
• Phase IV clinical studies, which are studies conducted after initial approval of the drug; and
• Product withdrawal support services and other types of periapproval studies such as surveillance studies,
FDA mandated commitments generally focusing on characterizing a drug’s safety in large, diverse patient
groups, and prescription to switch studies.