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RCTs should be designed "to elucidate within-group variability, which can only be done if the hierarchy of evidence is replaced by a network that takes into account the relationship between epidemiological and laboratory research" [37] The hierarchy of evidence produced by a study design has been questioned, because guidelines have "failed to ...
A research design typically outlines the theories and models underlying a project; the research question(s) of a project; a strategy for gathering data and information; and a strategy for producing answers from the data. [1] A strong research design yields valid answers to research questions while weak designs yield unreliable, imprecise or ...
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 .
The International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, a 2015 Swiss NGO of pharmaceutical companies and others, defined a contract research organization (CRO), specifically pertaining to clinical trials services as: [8]: 10 "A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or ...
The data management plan describes the activities to be conducted in the course of processing data. Key topics to cover include the SOPs to be followed, the clinical data management system (CDMS) to be used, description of data sources, data handling processes, data transfer formats and process, and quality control procedure
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Design science research (DSR) is a research paradigm focusing on the development and validation of prescriptive knowledge in information science. Herbert Simon distinguished the natural sciences, concerned with explaining how things are, from design sciences which are concerned with how things ought to be, [1] that is, with devising artifacts to attain goals.
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 ...