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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 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trial
Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, pharmaceutical drug, drugs, medical nutrition therapy, 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 institutional review board, 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 experiment, pi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
WuXi AppTec
WuXi AppTec (WuXi is pronounced as ''Wu-shee'') is a global pharmaceutical, biopharmaceutical, and medical device company. History WuXi PharmaTech was founded in December 2000 in Shanghai by organic chemist Ge Li. The company opened chemistry facilities in Tianjin in 2007. In 2008, WuXi PharmaTech acquired AppTec Laboratory Services Inc., a US-based company founded in 2001 with expertise in medical-device and biologics testing and with facilities in St. Paul, MN; Philadelphia, PA; and Atlanta, GA. In the same year the company was renamed WuXi AppTec. WuXi AppTec opened a toxicology facility in Suzhou in 2009. WuXi AppTec's subsidiary, WuXi STA, opened a large-scale manufacturing facility in Jinshan in 2010. The company began a biologics discovery, development, and manufacturing operation in Shanghai and Wuxi City in 2011. At the same year, WuXi AppTec acquired MedKey, a China-based clinical research company, and Abgent, a San Diego company and one of the world's largest manu ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
ICON PLC
ICON plc is an Irish headquartered multinational healthcare intelligence and clinical research organisation that provides consulting, clinical development and commercialisation services for the pharmaceutical industry. The company is listed on the Nasdaq stock exchange in the United States, and had approximately 41,900 employees in 106 locations spread across 55 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, Germany, and Japan. Two years later, ICON shares started to be traded on Nasdaq. In 2013, PRA Health Sciences was acquired by KKR, which listed the company on the Nasdaq in November 2014 and maintained shares until September 2019. In August 2017, the company acquired Conshohocken-based real-world healthcare data, analy ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Charles River Laboratories
Charles River Laboratories International, Inc. is an American pharmaceutical company specializing in preclinical and clinical laboratory, gene therapy and cell therapy services and supplies for the pharmaceutical, medical device and biotechnology industries. The company has over 150 facilities, operates in 21 countries, and employs over 21,000 people worldwide. Charles River Laboratories frequently criticized by animal rights activists, who condemn the company's use of dogs and primates for pharmaceutical research. The company is also a major harvester of blood from horseshoe crabs. History Charles River was founded in 1947 by Henry Foster, a young veterinarian who purchased one thousand rat cages from a Virginia farm and set up a one-person laboratory in Boston overlooking the Charles River. He supplied local researchers with laboratory animal models. In 1955, the company's headquarters were relocated to their current home in Wilmington, Massachusetts. The organization b ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Syneos Health
Syneos Health (formerly InVentiv Health Incorporated and INC Research) is an American company that provides contract research and commercial services to pharmaceutical and biotechnology companies. Based in Morrisville, North Carolina, the company specializes in helping other companies with late-stage clinical trials, but also provides commercial services to market health treatments. Syneos Health was formed from the merger of InVentiv Health and INC Research, each formed from the consolidation of several companies in the contract research industry. It was listed on Nasdaq until 2023 when the company was taken private by Elliott Investment Management. History Syneos Health was formed from the merger and acquisition of several companies including InVentiv Health and INC Research. Through InVentiv Health, part of the company's history can be traced back to Snyder Communications, a company founded by Daniel M. Snyder in the 1980s. Snyder Communications had an initial public of ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
IQVIA
IQVIA, formerly Quintiles and IMS Health, Inc., is an American Fortune 500 and S&P 500 multinational company serving the combined industries of health information technology and clinical research. IQVIA is a provider of biopharmaceutical development, professional consulting and commercial outsourcing services, focused primarily on Phase I-IV clinical trials and associated laboratory and analytical services, including investment strategy and management consulting services. It has a network of more than 88,000 employees in more than 100 countries and a market capitalization of US$49 billion as of August 2021. As of 2023, IQVIA was reported to be one of the world's largest contract research organizations (CRO). 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), ... [...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, such as via a risk scoring model, 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 Sy ... [...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). However, 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 other factors like regulating lasers, cellular phones, and condoms. In addition, the FDA takes control of diseases i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
