Quintiles Transnational Holdings Inc. provides biopharmaceutical development services and commercial outsourcing services. The company conducts business in approximately 100 countries. Segments The company offers its services through two segments, Product Development and Integrated Healthcare Services. Product Development segment This segment provides services and expertise that enable biopharmaceutical companies to outsource the clinical development process from first-in-man clinical trials to post-launch monitoring. Product Development is comprised of Clinical Solutions & Services and Consulting. Clinical Solutions & Services provides services necessary to develop biopharmaceutical products, including project management and clinical monitoring functions for conducting multi-site clinical trials (generally Phase II-IV) and clinical trial support services that can improve clinical trial decision-making and data management and strategic planning and design services that can improve decisions and performance. Consulting provides strategy and management consulting services based on deep life science expertise and advanced analytics, as well as regulatory and compliance consulting services. Clinical Solutions & Services Project Management and Clinical Monitoring Clinical Solutions & Services enables the conduct and coordination of multi-site clinical trials (generally Phase II-IV). 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. Study Design and Operational Planning: The company assists its customers in preparing the study protocol, designing clinical report forms and identifying appropriate patients, sites and the optimal country mix to meet their objectives, among other key upfront decisions. The study protocol defines the medical hypotheses to be examined, the number of patients required to produce statistically valid results, the period of time over which they must be tracked, the frequency and dosage of drug administration and the study procedures. Investigator/Site Recruitment: During clinical trials, the drug is administered to patients by physicians, referred to as investigators, at hospitals, clinics or other sites. Through its global prime site and partner programs, the company has relationships with investigators who conduct its clinical trials worldwide. The company provides its investigators the resources and tools they need to conduct the clinical trials. Site and Regulatory Start Up: The process of identifying, training and contracting with sites while also securing regulatory and ethics approval is a complex and time-consuming aspect of clinical trials. The company utilizes technology and analytics to simplify and streamline this process, reducing time to first patient in and laying the groundwork for successful clinical trial execution. Patient Recruitment: The company assists its customers in recruiting patients for clinical trials through investigator relationships, media advertising, use of Web-based techniques and other methods. The company also helps to ensure patients are retained for the duration of the clinical trials. Its patient recruitment system includes informatics tools and media-based recruitment methods to provide pools of prescreened patients, as well as an enrollment process and a call center. Clinical Monitoring: The company deploys and manages clinical research associates (CRAs) to work with and monitor sites to assure the quality of the data, which it gathers according to Good Clinical Practice (GCP), and International Conference on Harmonisation, regulations and guidelines, and to meet the customers’ and regulatory authorities’ requirements according to the study protocol. CRAs also assist with site initiation, training, patient enrollment and retention. Project Management: The company’s project managers help customers navigate the complexity of the clinical trial process and coordinate all of the various activities, data streams and timelines associated therewith. The company’s proj
quintiles transnational hold
4820 Emperor Boulevard
Durham, NC 27703
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