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A clinical research associate ( CRA ), also called a clinical monitor or trial monitor, is a health-care professional who performs many activities related to medical research, particularly clinical trials. Clinical research associates work in various settings, such as pharmaceutical companies, medical research institutes and government agencies.
Clinical data management ( CDM) is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. [ 1] Clinical data management ensures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and ...
A Clinical Research Coordinator (CRC) is a person responsible for conducting clinical trials using good clinical practice [ 1] (GCP) under the auspices of a Principal Investigator (PI). Good clinical practices principles have been defined by Madelene Ottosen, RN, MSN, of The University of Texas Health Science Center at Houston [ 2] as:
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 ...
A Clinical Trial Management System ( CTMS) is a software system used by biotechnology and pharmaceutical industries to manage clinical trials in clinical research. The system maintains and manages planning, performing and reporting functions, along with participant contact information, tracking deadlines and milestones.
Health informatics. Medical informatics introduces information processing concepts and machinery to the domain of medicine. Health informatics is the study and implementation of computer structures and algorithms to improve communication, understanding, and management of medical information. [ 1] It can be viewed as a branch of engineering and ...
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) [1] and the World Health Organization (WHO), [2] require data and safety monitoring protocols for Phase I and II clinical trials ...
Clinical research is a branch of medical research that involves people and aims to determine the effectiveness ( efficacy) and safety of medications, devices, diagnostic products, and treatment regimens intended for improving human health. [ 1][ 2] These research procedures are designed for the prevention, treatment, diagnosis or understanding ...
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