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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 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 CRA may work directly with the sponsor company of a clinical trial, as an independent freelancer or for a contract research organization (CRO). A clinical research associate ensures compliance with the clinical trial protocol, checks clinical site activities, makes on-site visits, reviews case report forms (CRFs), and communicates with ...
Many contract research organizations (CROs) provide document management services to support trial master file management. In addition, there are a small number of niche companies that focus specifically on the trial master file.
Responsibility for data and safety monitoring depends on the phase of the study and may be conducted by sponsor or Contract research organization (CRO) staff or contractor, and/or by the Principal clinical investigator/project manager conducting the study. Regardless of the method used, monitoring must be performed on a regular basis.
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Pharmaceutical Product Development (PPD) is a global contract research organization (CRO) providing comprehensive, integrated drug development, laboratory and lifecycle management services. In December 2021, PPD became a wholly owned subsidiary of Thermo Fisher Scientific .
This is a list of United States federal agencies that are primarily devoted to research and development, including their notable subdivisions. These agencies are responsible for carrying out the science policy of the United States .