Profile: Quintiles Transnational Holdings Inc (Q.N)
Quintiles Transnational Holdings Inc., incorporated on November 19, 2009, is a provider of biopharmaceutical development services and commercial outsourcing services. The Company is engaged in the development and commercialization of pharmaceutical therapies. The Company's segments include Product Development and Integrated Healthcare Services. The Company offers therapeutic, scientific and analytics services to its biopharmaceutical and other healthcare customers. The Company's Product Development segment is a contract research organization (CRO) and is focused on Phase II-IV clinical trials and associated laboratory and analytical activities. The Company's Integrated Healthcare Services segment includes commercial pharmaceutical sales and service organizations. Its Integrated Healthcare Services segment provides services, including commercial services, such as contract pharmaceutical sales forces, and healthcare business services for the healthcare sector, such as phase research, market access and consulting, health information analytics and technology consulting, and other healthcare solutions.
The Company's Product Development segment serves biopharmaceutical companies, including medical device and diagnostics companies, which outsource services associated with the development of pharmaceutical products, such as clinical trials. Integrated Healthcare Services serves markets related to the use of biopharmaceutical products. It offers late-phase services, such as observational studies, comparative effectiveness studies, and product and disease registry services. The Company offers biopharmaceutical services in biopharmaceutical markets, including the United States, Japan, Europe, Brazil, Russia, India and China. The Company provides services for the development or commercialization of biopharmaceutical and biologic products. The Company has a therapeutic focus on oncology, cardiovascular, central nervous system, diabetes and internal medicine.
The Company's Product Development segment offers clinical solutions and services, and advisory services. It provides services, which enable biopharmaceutical companies to outsource the clinical development process from first-in-man trials to post-launch monitoring. Clinical Solutions and Services provides services for the development of biopharmaceutical products, including project management and clinical monitoring functions for conducting multi-site clinical trials (Phase II-IV); clinical trial support services for clinical trial decision making, such as global clinical trial laboratories, data management, biostatistical, safety and pharmacovigilance, clinical development trials (Phase I), and strategic planning and design services. Its service offerings include protocol design, feasibility and operational planning, site start up, patient recruitment, project management and monitoring of the investigator sites and data from patient visits. The Company assists its customers in preparing the study protocol, designing clinical report forms and identifying appropriate patients and sites. The Company also assists its customers in recruiting patients for clinical trials through investigator relationships, media advertising and use of Web-based techniques and other methods. The Company, through informatics tools and media-based recruitment methods, engages in identifying and recruiting the patients. The Company manages clinical research associates (CRAs) to work with and monitor sites. CRAs also assist with site initiation, training, patient enrollment and retention.
The Company offers a range of functional services and consultation for the clinical trials to collect, analyze and report the data for regulatory approval. The Company's clinical trial support services include Clinical Data Management, Biostatistical Services, Cardiac Safety and Electrocardiogram (ECG) Laboratory Services, Safety and Pharmacovigilance Operations and Phase I Clinical Pharmacology Services. The Company provides its customers an end-to-end clinical trial laboratory and research services. Its Q2 Solutions include Clinical Trial Laboratories, Genomic Laboratory and Bioanalytical Laboratories. The Company's data management services provide support for the collection, organization, validation and analysis of clinical data. It also provides statistical analyses of scientific databases for various phases of the drug development process. Its centralized ECG laboratory in India provides continuous global collection and analysis of ECGs by trained cardiologists as part of clinical trials. Phase I clinical trials often involve testing a new drug on a limited number of healthy volunteers and patients. Phase I clinical trial solutions include dose ranging, bioavailability/bioequivalence studies, pharmacokinetic/pharmacodynamic (PK/PD) modeling, first administration to humans, multiple dose tolerance, dose effect relationship and metabolism studies. The Company supports the laboratory testing and reporting needs in various phases of clinical trials, offering biomarker testing through a network of clinical trial laboratories. Its services include assay development and validation, provision of clinical trial materials, customized lab report design, and specimen management and archival.
The Company supports clinical trials across the world through its facilities in the United States, the United Kingdom, South Africa, India, China, Singapore, Japan, Argentina and Brazil. The Company provides a range of solutions in support of its customers' clinical trial and research efforts, including experiment design, sample analysis, nucleic acid isolation, gene expression profiling, genotyping, next-generation sequencing and bioinformatics. Its services include whole genome to focused set gene expression profiling and genotyping assays along with deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) sequencings services, sequence enrichment technologies and bioinformatics support. The Company offers a range of good laboratory practice (GLP) and non-GLP bio analytical testing for PK/PD, studies, and absorption, distribution, metabolism and elimination studies in the early phases of clinical testing. Through its strategic planning and design services, the Company offers consultation services, including portfolio, program and protocol planning and design, biomarker consultation, benefit-risk management, regulatory affairs, biostatistics, modeling and simulation, and personalized medicine. It serves biopharmaceutical companies, which engage in the area of biomarker and genomics research, testing and analysis with various services, including biomarker discovery and development, assay development and validation, genomics, digital pathology and consultation.
The Company is engaged in the development and use of modeling and simulation techniques for the drug development process. Its services include population PK/PD modeling and simulation, and clinical trial simulation to test various trial design options simulated on computers before performing the actual clinical trial. The Company, through its center for integrated drug development, is engaged in clinical research planning with a design platform that includes a modeling and simulation process for scenario planning and risk assessment to support portfolio, program development and protocol planning. It also provides medical and regulatory affairs services for its biopharmaceutical customers. Its medical services include medical oversight of clinical trials, review and interpretation of adverse experiences, medical writing of reports and trial protocols, and strategic planning of drug development programs. Regulatory services for product registration include regulatory strategy design, document preparation, publishing, consultation and liaison with various regulatory authorities. The Company's advisory services include Product Development Strategy Consulting, Regulatory and Compliance Consulting, and Process and information technology (IT) Implementation Consulting. The Company provides regulatory and compliance consulting services to the biopharmaceutical industry related to good manufacturing practice (GMP), Good Clinical Practice (GCP), GLP, global regulatory affairs, and quality systems engineering and validation.
Integrated Healthcare Services
The Company's Integrated Healthcare Services segment provides the healthcare industry with both geographic presence and commercial solutions. It also provides commercial services, real-world and late-phase research, and communication and health engagement services. The Company's commercial services include contract sales, market entry/market exit, integrated multichannel management, patient engagement services, and market access and commercialization consulting. The Company provides various staffing options, including direct hire, work arrangements, leave of absence and strike force arrangements in both full-time and flex-time solutions. Its training and development services integrate traditional, distance-learning and Web-based services. Market entry and market exit services are integrated solutions that include assistance with regulatory compliance, market access, brand strategy, import and distribution logistics, and sales and marketing programs.
The Company's integrated multichannel solutions serve the biopharmaceutical companies to optimize channel mix, including sales force mix to execute the sales and marketing strategy for individual drugs across multiple channels, including the use of sales representatives, e-detailing, video, mail, call center, Webinars and online portals. Its health management services offer clinical and educational solutions and provide services across a range of pre-launch, launch and post-launch opportunities. It also provides customers with solutions in a spectrum from patient adherence programs to clinical trial educators that assist in recruitment, education and retention of patients in clinical trials. The Company's market access services serve the biopharmaceutical customers in the development and execution of a strategy for bringing products into the market. It helps to create product positioning, pricing and formulary access and reimbursement strategies. The Company's real-world and late phase research services include observational studies, product and disease registries, safety and surveillance, risk management and risk evaluation and mitigation strategies, expanded labeling, health economics and outcomes, patient-reported outcomes, medical record review, and electronic medical record and electronic health record (EHR) studies.
The Company's communication and health engagement services include digital patient services, and brand and scientific communications. The Company's digital patient services mobilize patients into clinical research, observational studies and disease management programs, retain patients through engagement strategies, and generate evidence, such as patient reported outcomes, laboratory data and device diagnostics from patients. Its communications group offers a range of pre-launch, launch and post-launch services, including communications strategies and planning, product positioning and branding, opinion leader development, faculty training, symposia, promotional programs, sponsored publications, media-based programs, patient education and clinical experience programs. Through its health service platform, the Company offers a range of services to organizations and users across the care continuum, including governments, hospitals, physician offices and pharmacies. These services include clinical management analytics, decision support services, medication adherence and health outcome optimization services, and Web-based systems for measuring quality improvement.
The Company competes with Pharmaceutical Product Development, Inc., PAREXEL International Corporation, ICON plc, inVentiv Health, Inc., INC Research, PRA International, Laboratory Corporation of America Holdings, Publicis Healthcare Communications Group, Publicis Selling Solutions, United Drug plc, EPS Corporation and CMIC HOLDINGS Co., Ltd.
Quintiles Transnational Holdings Inc
4820 Emperor Blvd
DURHAM NC 27703-8426
Company Web Links
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