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 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.
Labcorp Drug Development is a contract research organization (CRO) headquartered in Burlington, North Carolina, providing nonclinical, preclinical, clinical and commercialization services to pharmaceutical and biotechnology industries. Formerly called Covance, the company is part of Labcorp, which employs more than 70,000 people worldwide. Labcorp Drug Development claims to provide the world's largest central laboratory network.
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.
Clinical monitoring is the oversight and administrative efforts that monitor a participant's health and efficacy of the treatment during a clinical trial. Both independent and government-run grant-funding agencies, such as the National Institutes of Health (NIH) and the World Health Organization (WHO), require data and safety monitoring protocols for Phase I and II clinical trials conforming to their standards.
An electronic data capture (EDC) system is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials. EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drugs and medical devices. EDC solutions are widely adopted by pharmaceutical companies and contract research organizations (CRO).
Parexel International is an American provider of biopharmaceutical services. It conducts clinical trials on behalf of its pharmaceutical clients to expedite the drug approval process. It is the second largest clinical research organization in the world and has helped develop approximately 95% of the 200 top-selling biopharmaceuticals on the market today. The company publishes the annual Parexel R&D Statistical Sourcebook, operates the Parexel-Academy, and councils all of the top 50 biopharmaceutical and top 30 biotechnology companies.
Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment.
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, consulting and commercial outsourcing services, focused primarily on Phase I-IV clinical trials and associated laboratory and analytical services, including 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 2017, IQVIA was reported to be one of the world's largest contract research organizations.
A Site Management Organization (SMO) is an organization that provides clinical trial-related services to a contract research organization (CRO), a pharmaceutical company, a biotechnology company, a medical device company, or a clinical site. The site is usually a hospital or a similar health care institution that has adequate infrastructure and staff to meet the requirements of the clinical trial protocol. The scope of an SMO's responsibility is limited to the site and hence the eponymous title. Some of the responsibilities include:
Wolfe Laboratories, Inc. (WLI) was a contract research organization (CRO) headquartered in Woburn, Massachusetts. It provided research and development services as well as GLP analytical services for products in late discovery phase through early clinical phases of drug development. It served clients in New England, the US and internationally. Laboratory operations took place in a large 21,000-square-foot (2,000 m2) facility.
The African Malaria Network Trust (AMANET) is a pan-African international NGO headquartered in Dar es Salaam, Tanzania. It originally started its activities as African Malaria Vaccine Testing Network (AMVTN) in 1995 with the primary goal of preparing Africa in planning and conducting malaria vaccine trials. In order to widen the scope in malaria interventions, AMVTN was succeeded by AMANET on 14 March 2002. Although the primary goal of AMANET has remained malaria vaccine development, the organization in its expanded role includes other intervention measures such as antimalaria drugs and vector control.
A contract manufacturing organization (CMO), more recently referred to as a contract development and manufacturing organization (CDMO) to avoid the acronym confusion of Chief Medical Officer or Clinical Monitoring Organization in the pharma industry, is a company that serves other companies in the pharmaceutical industry on a contract basis to provide comprehensive services from drug development through drug manufacturing. This allows major pharmaceutical companies to outsource those aspects of the business, which can help with scalability or can allow the major company to focus on drug discovery and drug marketing instead.
Healthcare in Georgia is provided by a universal health care system under which the state funds medical treatment in a mainly privatized system of medical facilities. In 2013, the enactment of a universal health care program triggered universal coverage of government-sponsored medical care of the population and improving access to health care services. Responsibility for purchasing publicly financed health services lies with the Social Service Agency (SSA).
Cytel is a multinational statistical software developer and contract research organization, headquartered in Cambridge, Massachusetts, USA. Cytel provides clinical trial design, implementation services, and statistical products primarily for the biotech and pharmaceutical development markets.
Patient recruitment includes a variety of services—typically performed by a Patient Recruitment Service Provider—to increase enrollment into clinical trials. Presently, the patient recruitment industry is claimed to total $19 billion per year.
The NIH Clinical Center is a hospital solely dedicated to clinical research at the National Institutes of Health campus in Bethesda, Maryland. The Clinical Center, known as Building 10, consists of the original part of the hospital, the Warren Grant Magnuson Clinical Center, and the newest addition, the Mark O. Hatfield Clinical Research Center. The two parts are connected to form one large building.
The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phases start with testing for drug safety in a few human subjects, then expand to many study participants to determine if the treatment is effective. Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays.
Medpace Holdings, Inc. is a global clinical research organization (CRO) based in Cincinnati, Ohio, employing approximately 5,400 people. Medpace's mission statement is "to accelerate the global development of safe and effective medical therapeutics" through its high science and disciplined operating approach that leverages local, regulatory, and deep therapeutic expertise across all major areas, including oncology, cardiology, metabolic disease, endocrinology, central nervous system, and anti-viral and anti-infective. Operating under a full-service model, Medpace provides a therapeutically focused, integrated, global approach to clinical development. The company also offers global central laboratory, imaging core laboratory, and bioanalytical laboratory services, as well as a Phase I unit located on its headquarters and clinical research campus in Cincinnati, Ohio.
ICON plc is an Irish headquartered Nasdaq listed multinational healthcare intelligence and clinical research organisation that provides consulting, clinical development and commercialisation services for the pharmaceutical industry. As of June 2023, ICON had approximately 41,160 employees in 108 locations spread across 53 countries.
The Solidarity trial for treatments is a multinational Phase III-IV clinical trial organized by the World Health Organization (WHO) and partners to compare four untested treatments for hospitalized people with severe COVID-19 illness. The trial was announced 18 March 2020, and as of 6 August 2021, 12,000 patients in 30 countries had been recruited to participate in the trial.
