Profile: Syneos Health Inc (SYNH.OQ)
18 Apr 2019
Syneos Health, Inc., formerly INC Research Holdings, Inc., incorporated on August 13, 2010, is a global contract research organization (CRO). The Company focuses on Phase I to Phase IV clinical development services for the biopharmaceutical and medical device industries. The Company operates through two segments: Clinical Development Services and Phase I Services. The Company provides a range of services, which support the entire drug development process from Phase I to Phase IV, allowing it to offer its customers an integrated suite of investigative site support and clinical development services. The Company provides total biopharmaceutical program development, while also providing discrete services for any part of a trial. The Company's Clinical Development Services segment offers a range of clinical development services, including full-service global studies, as well as ancillary services, such as clinical monitoring, investigator recruitment, patient recruitment, data management, study reports to assist customers with their drug development process, quality assurance audits and specialized consulting services. The Phase I Services segment focuses on clinical development services for Phase I trials, which include scientific exploratory medicine, first-in-human studies through proof-of-concept stages and support for Phase I studies in established compounds.
The Company's Clinical Development Services include Clinical Trial Management, Data Services, Strategic and Regulatory Services, Real World and Late Stage Services and Functional Services. The Company offers all select and stand-alone clinical trial services, as well as full-service, global studies through its clinical development services. Its clinical trial management services include Patient Recruitment and Retention, Project Management, Clinical Monitoring, Drug Safety/Pharmacovigilance, Medical Affairs, Quality Assurance, Regulatory and Medical Writing and Functional Services. Its patient recruitment services group helps identify and manage appropriate vendors, focuses on patient recruitment and retention strategies, and acts as a liaison to media outlets and other vendors that it has validated. Its project managers provide leadership in managing clinical trials. Its clinical monitors oversee the conduct of a clinical trial by working with and monitoring clinical research sites. The Company's drug safety teams are located across the United States, Europe, Latin America and Asia-Pacific. It provides global drug safety services in all Phases of clinical research for serious adverse event/adverse event collection, evaluation, classification, reporting, reconciliation, post-marketing safety and pharmacovigilance. The Company has in-house physicians providing medical monitoring, scientific and medical support for project management teams and clinical research sites.
The Company has quality assurance department that conducts independent audits of all ongoing projects and processes, offers contracted quality assurance services to customers, including audits of clinical research sites and of all vendors to the clinical research industry; mock regulatory inspections and clinical research site inspection-readiness training, standard operating procedure development, and quality assurance program development/consultation. The Company offers regulatory and medical writing services across the entire biopharmaceutical product lifecycle. The Company's functional service provider (FSP) offers a tool to help sponsors review their approach to functional areas of clinical research.
The Company's data services include Clinical Data Management, Electronic Data Capture (EDC) and Biostatistics. The clinical data management services allows the Company to confirm that the clinical trial database is ready, populated and locked, with verification and validation procedures throughout every phase of a clinical trial. The Company utilizes three EDC platforms: Medidata Rave, Oracle Clinical Remote Data Capture and Oracle Health Sciences InForm products. The Company's biostatistics team provides customers with guidance on building a statistical plan to meet regulatory and safety requirements, as well as an analysis of the resulting study data. In addition, it provides support for independent drug safety monitoring boards and a range of related services.
The Company offers Strategic Services and Regulatory Services. The Company's advisory services include strategic drug development, clinical development plans, registration strategies, exit strategies, transitional clarity, good clinical practice compliance strategies, clinical operations optimization, pricing and reimbursement, and due diligence. The Company offers regulatory services across the entire biopharmaceutical product lifecycle. The Company's Global regulatory services include around the world regulatory submissions, regulatory strategy and agency meetings, early development consultancy, data safety monitoring board and data review committee management, chemistry manufacturing and controls, contemporary regulatory interpretation, investigational new drug (IND), applications and clinical trial authorizations. Its real world and late phase group conducts real world studies to understand how a treatment, service or method of delivering care works when applied in real world, clinical practice environments. These services include patient registries, surveillance and observational studies, patient/health outcomes research and economic studies.
The Company competes with ICON plc, inVentiv Health, Inc., Laboratory Corporation of America Holdings, Medpace Holdings, Inc., PAREXEL International Corporation, Pharmaceutical Product Development, LLC, PRA Health Sciences, Inc. and Quintiles IMS Holdings, Inc.
Syneos Health Inc
1030 Sync Street
MORRISVILLE NC 27560