Profile: Covance Inc (CVD.N)
Covance Inc. is a drug development services company providing a range of early-stage and late-stage product development services on a worldwide basis primarily to the pharmaceutical, biotechnology and medical device industries. The Company also provides laboratory testing services to the chemical, agrochemical and food industries. The services it provides constitutes two segments: early development services, which includes discovery support services, preclinical services and clinical pharmacology services, and late-stage development services, which includes central laboratory, Phase II-IV clinical development, and market access services. In 2011, Covance acquired certain assets of TRAC Microbiology, Inc., a food microbiology and chemistry laboratory.
The Company’s preclinical services include toxicology services, pharmaceutical chemistry, nutritional chemistry and related services. Its preclinical area has introduced technologies for client access to data, such as StudyTracker, electronic animal identification, multimedia study reports and animal and test tube measures of induced cell proliferation or reproduction. StudyTracker is an Internet-based client access product, which allows clients of toxicology, bioanalytical, metabolism and reproductive and developmental toxicology services to review study data and schedules on a near real-time basis. The Company has laboratories in locations, which include Madison, Wisconsin; Chandler, Arizona, and Greenfield, Indiana in the United States and Harrogate, United Kingdom; Alnwick, United Kingdom; Muenster, Germany, and Porcheville, France in Europe. It also has bioanalytical laboratories in the United States in Indianapolis, Indiana and Chantilly, Virginia, and an administrative and a sales office in Tokyo, Japan. The Company at its Lilly's 450 acre research campus in Greenfield, Indiana provides a number of services at that location, including non-Good Laboratory Practice (GLP) toxicology, in vivo pharmacology, quality control laboratory and imaging.
The Company’s preclinical toxicology services include in vivo toxicology studies, which are studies of the effects of drugs in animals; genetic toxicology studies, which include studies of the effects of drugs on chromosomes, as well as on genetically modified mice; and other specialized toxicology services. In pharmaceutical chemistry services, the Company determines the metabolic profile and bioavailability of drug candidates. It also provides laboratory testing services to the chemical and agricultural chemical industries. The Company offers a range of services to agricultural chemical manufacturers to determine the potential risk to humans, animals and the environment from plant protection products such as pesticides. During the year ended December 31, 2011, Covance launched a set of chemistry, manufacturing and controls (CMC) pharmaceutical development services, including active pharmaceutical ingredient (API) development and supply, API characterization, preformulation, formulation and regulatory submission.
The Company, in its nutritional chemistry services, offers a range of services to the food, nutriceutical and animal feed industries, including nutritional analysis and equivalency, nutritional content fact labels, microbiological and chemical contaminant safety analysis, pesticide screening and stability testing. The Company provides custom polyclonal and monoclonal antibody services for research purposes and purpose-bred animals for biomedical research. The purpose-bred research animals it provides are required by pharmaceutical and biotechnology companies, university research centers and contract research organizations as part of required preclinical animal safety and efficacy testing. Through a variety of processes, technology and specifically constructed facilities, it provides purpose-bred, pre-acclimated and specific pathogen free animals. Covance also has an animal biosafety level 2 (ABSL-2) containment vivarium to allow the Company to provide vaccine testing.
The Company provides lead optimization services, including custom immunology and antibody services, metabolism studies and pharmacokinetic screening, as well as non-GLP toxicology, in vivo pharmacology, imaging services and biomarker services. It provides high throughput GLP and non-GLP biomarker services from its central laboratory, bioanalytical and toxicology laboratories, and offers bioimaging capabilities and cardiac related biomarkers for animals and humans. In 2011, the Company’s commenced offering discovery and translational services from Alnwick, United Kingdom and Shanghai, China. The Company’s bioanalytical testing services, which are conducted in its bioanalytical laboratory in Indianapolis, Indiana and in the Company’s immunoanalytical facility in Chantilly, Virginia, as well as in its laboratories in Madison, Wisconsin, Harrogate, United Kingdom and Shanghai, China, help determine the appropriate dose and frequency of drug application from late discovery evaluation through Phase III clinical testing on a full-scale, globally integrated basis. It provides clinical pharmacology services, including first-in-human trials, of new pharmaceuticals at its five clinics located throughout the United States and its clinics in Leeds, United Kingdom and Basel, Switzerland. The Company offers its clients access to specialized patient populations needed for Phase II trials in specific therapeutic areas.
The Company is a provider of central laboratory services. It has four central laboratories, one in each of the United States, Switzerland, Singapore and China that provide central laboratory services to biotechnology and pharmaceutical customers. In addition, the laboratories are capable of delivering customized data electronically within 24 hours of test completion. Covance also offers pharmacogenomic testing and sample storage technologies in conjunction with our central laboratory services. Central laboratory services also offers LabLink, an Internet-based client access program that allows clients to review and query clinical trial lab data on a near real-time basis, and the Covance Local Laboratories service, which uses a system to harmonize laboratory results from local and regional laboratories to help expand the reach of traditional central laboratory services.
The Company’s central laboratories have an automated kit production line that is located in the United States and supplies kits to investigator sites worldwide. The Company’s biorepository facility in Greenfield, Indiana is dedicated to long-term storage of clinical trial specimens. This facility is able to store a range of specimens, including plasma, serum, whole blood, deoxyribonucleic acid, peripheral blood mononuclear cell and tissue. It offers a range of clinical trial services, including the full management of Phase II through IV clinical studies. The Company provides the following core services either on an individual or aggregated basis, 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. It has experience in managing clinical trials in North America, Europe, South America and Asia Pacific. These trials may be conducted separately or simultaneously as part of a multinational development plan. The Company manages every aspect of clinical trials from clinical development plans and protocol design to New Drug Applications, among other supporting services. The Company’s clinical development services utilize Trial Tracker, a Web-enabled clinical trial project management and tracking tool, which allows both its employees and clients to review and manage the various aspects of clinical trial projects. In 2011, the Company launched XcellerateTM, a methodology, which enables the Company to make recommendations onsite, investigator and geographic selection.
Periapproval trials are studies conducted around the time of New Drug Application approval, generally after a drug has undergone clinical efficacy and safety testing and the New Drug Application has been submitted to the Food and Drug Administration (FDA). It offers a range of periapproval services, including: 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; product withdrawal support services and other types of periapproval studies, such as post-marketing surveillance studies, FDA mandated post-marketing commitments generally focusing on characterizing a drug's safety in diverse patient groups, and prescription to over-the-counter switch studies.
The Company offers a range of reimbursement and healthcare economics consulting services, including outcomes and pharmacoeconomic studies, reimbursement planning, reimbursement advocacy programs, risk evaluation and mitigation strategy (REMS) services, registry services and specialty pharmacy services. Pharmaceutical, biotechnology and medical device manufacturers purchase these services from the Company. It offers InTeleCenter services that employ Internet and electronic media to manage customer communications. InTeleCenter programs include reimbursement hotlines, patient assistance programs and patient compliance REMS programs.
The Company competes with Charles River Laboratories International Inc., Pharmaceutical Product Development, Inc., WIL Research Laboratories, Inc., WuXi PharmaTech Inc., MPI Research Inc., Quintiles Transnational Corp., Parexel International Corporation, INC Research, LLC, ICON p.l.c., PRA International, i3 Research, PharmaNet Development Group, Inc. and Quest Diagnostics Incorporated.
210 Carnegie Center
PRINCETON NJ 08540