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Contract Research Organization
In the life sciences, a contract research organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. A CRO may provide such services as biopharmaceutical development, biological assay development, commercialization, clinical development, clinical trials management, pharmacovigilance, outcomes research, and Real world evidence. CROs are designed to reduce costs for companies developing new medicines and drugs in niche markets. They aim to simplify entry into drug markets, and simplify development, as the need for large pharmaceutical companies to do everything ‘in house’ is now redundant. CROs also support foundations, research institutions, and universities, in addition to governmental organizations (such as the NIH, EMA, etc.). Many CROs specifically provide clinical-study and clinical-trial support for drugs and/or medical devices. However, ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Life Sciences
This list of life sciences comprises the branches of science that involve the scientific study of life – such as microorganisms, plants, and animals including human beings. This science is one of the two major branches of natural science, the other being physical science, which is concerned with non-living matter. Biology is the overall natural science that studies life, with the other life sciences as its sub-disciplines. Some life sciences focus on a specific type of organism. For example, zoology is the study of animals, while botany is the study of plants. Other life sciences focus on aspects common to all or many life forms, such as anatomy and genetics. Some focus on the micro-scale (e.g. molecular biology, biochemistry) other on larger scales (e.g. cytology, immunology, ethology, pharmacy, ecology). Another major branch of life sciences involves understanding the mindneuroscience. Life sciences discoveries are helpful in improving the quality and standard of life and h ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trial
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
WuXi AppTec
WuXi AppTec (WuXi pronounced ''Wu-shee'') is a global pharmaceutical, biopharmaceutical, and medical device company. The company covers the development cycle through five core operations, including small molecule R&D and manufacturing, biologics R&D and manufacturing, cell therapy and gene therapy R&D and manufacturing, medical device testing, and molecular testing and genomics. History WuXi's founder is Dr. Ge Li, an organic chemist, who founded WuXi PharmaTech in Shanghai in December 2000. WuXi established services in synthetic chemistry in 2001, manufacturing process development in 2003, research manufacturing in 2004, bioanalytical services in 2005, service biology in 2006, and toxicology and formulation in 2007. On December 14, 2006, WuXi PharmaTech announced that it was ranked 173rd on the Deloitte Technology Fast 500 Asia Pacific 2006. The company opened chemistry facilities in Tianjin in 2007. In 2008, WuXi PharmaTech acquired AppTec Laboratory Services Inc., a US-based ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Charles River Laboratories
Charles River Laboratories International, Inc., is an American pharmaceutical company specializing in a variety of preclinical and clinical laboratory, gene therapy and cell therapy services for the Pharmaceutical, Medical device and Biotechnology industries. It also supplies assorted biomedical products, outsourcing services, and animals for research and development in the pharmaceutical industry (for example, contract research organization services) and offer support in the fields of basic research, drug discovery, safety and efficacy, clinical support, and manufacturing. The company's broad portfolio allowed them to support the development of approximately 85% of FDA-approved drugs in 2018. Its customers include leading pharmaceutical, biotechnology, agrochemical, government, and academic organization around the globe. The company has over 90 facilities, operates in 20 countries, and employs approximately 18,400 people worldwide. Charles River Laboratories is often criticize ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
ICON PLC
ICON (Public Limited Company) is a NASDAQ listed multinational clinical research organisation that provides consulting, clinical development and commercialization services for the pharmaceutical industry. Irish-headquartered healthcare intelligence and , ICON had 38,000 employees in 147 locations spread across 46 countries. History ICON was founded in Dublin, Ireland, by John Climax and Ronan Lambe in 1990. Since January 2010, Climax has held a position on the board of directors. Lambe retired from the board of directors in 2018. Between 1991 and 1996, ICON opened offices in the United Kingdom, United States, and Japan. A year later, ICON shares started to be traded on Nasdaq. In 2018, ICON won the ''PharmaTimes'' Clinical Researcher of the Year. ICON received 2019 Clinical Research Organization leadership awards in five categories, determined by ''Life Science Leader'' magazine and Industry Standard Research (ISR). In March 2017, Steve Cutler was appointed Chief Executiv ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Syneos Health
Syneos Health (formerly InVentiv Health Incorporated and INC Research) is a NASDAQ listed American multinational contract research organization based in Morrisville, North Carolina Morrisville is a town located primarily in Wake County, North Carolina, United States (a small portion extends into neighboring Durham County). The population was 18,576 at the 2010 census. The U.S. Census Bureau estimated the town's population t .... The company specializes in helping companies with late-stage clinical trials. In January 2018 INC Research acquired inVentiv Health, the parent company of a subsidiary, Syneos, and the resulting company was named Syneos Health. References External links {{authority control Biotechnology companies of the United States Companies based in North Carolina Contract research organizations Companies listed on the Nasdaq Biotechnology companies established in 2018 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
IQVIA
IQVIA, formerly Quintiles and IMS Health, Inc., is an American multinational company serving the combined industries of health information technology and clinical research. IQVIA is a provider of biopharmaceutical development and commercial outsourcing services, focused primarily on Phase I-IV clinical trials and associated laboratory and analytical services, including consulting services. It has a network of more than 88,000 employees in more than 100 countries and a market capitalization of $49 Billion as of August 2021. As of 2017, IQVIA was reported to be one of the world's largest contract research organizations. History IQVIA is the result of the 2016 merger of Quintiles, a leading global contract research organization, and IMS Health, a leading healthcare data and analytics provider The name of the modern company honors the legacy organizations. IQVIA: I (IMS Health), Q (Quintiles), and VIA (by way of). IMS Health IMS Health was best known for its collection of healthcar ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Labcorp
Laboratory Corporation of America Holdings, more commonly known as Labcorp, is an American healthcare company headquartered in Burlington, North Carolina. It operates one of the largest clinical laboratory networks in the world, with a United States network of 36 primary laboratories. Before a merger with National Health Laboratory in 1995, the company operated under the name Roche BioMedical. Labcorp performs its largest volume of specialty testing at its Center for Esoteric Testing in Burlington, North Carolina, where the company is headquartered.Full Description, Laboratory Corporation of America Hldg LH (NYSE) reuters.com [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Regulatory Risk Differentiation
Regulatory risk differentiation is the process used by a regulatory authority (the regulator - most often a tax administration) to systemically treat entities differently based on the regulator's assessment of the risks of the entity's non-compliance. Regulators can include law enforcement agencies. Entities refers to those under the authority/control of the regulator – in most cases ranging from individuals to companies (legal entities) to multinationals operating within the regulator's jurisdiction. The risk differentiation process requires the regulator to directly link a robust risk assessment to different regulatory responses (e.g. financial penalties, criminal imprisonment). Regulatory risk differentiation is also referred to as the Compliance Model in some regulatory agencies. See for example the Australian Prudential Regulatory Authority risk differentiation approach known as: PAIRS / SOARS. PAIRS is the Probability And Impact Rating System, while SOARS is the Supervisory ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
US FDA
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs, but involves such things as regulating lasers, cellular phones, and condoms, as well as control of disease in contexts varying from h ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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