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Remote Data Entry
{{Unreferenced, date=December 2009 A remote data entry (RDE) system is a computerized system designed for the collection of data in electronic format. The term is most commonly applied to a class of software used in the life sciences industry for collecting patient data from participants in clinical research studies—research of new drugs and/or medical devices. Typically, RDE systems provide: * a graphical user interface component for data entry * a validation component to check user data * a reporting tool for analysis of the collected data RDE software was started in the mid- to late-1980s as software installed locally on portable computers with modems. It has largely been replaced by a newer generation of software called electronic data capture, or EDC, that provides the same type of functionality over the Internet using web pages. See also * Clinical data acquisition * Electronic data capture An electronic data capture (EDC) system is a computerized system designed for the ... [...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 and h ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Research
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. Overview The term "clinical research" refers to the entire bibliography of a drug/device/biologic, in fact any test article from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the test article (including its safety toxicity if applicable and efficacy, if possible at this early stage) are studied. In the United States ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Graphical User Interface
The GUI ( "UI" by itself is still usually pronounced . or ), graphical user interface, is a form of user interface that allows users to interact with electronic devices through graphical icons and audio indicator such as primary notation, instead of text-based UIs, typed command labels or text navigation. GUIs were introduced in reaction to the perceived steep learning curve of CLIs ( command-line interfaces), which require commands to be typed on a computer keyboard. The actions in a GUI are usually performed through direct manipulation of the graphical elements. Beyond computers, GUIs are used in many handheld mobile devices such as MP3 players, portable media players, gaming devices, smartphones and smaller household, office and industrial controls. The term ''GUI'' tends not to be applied to other lower-display resolution types of interfaces, such as video games (where HUD (''head-up display'') is preferred), or not including flat screens like volumetric displays because ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Software Componentry
Component-based software engineering (CBSE), also called component-based development (CBD), is a branch of software engineering that emphasizes the separation of concerns with respect to the wide-ranging functionality available throughout a given software system. It is a reuse-based approach to defining, implementing and composing loosely coupled independent components into systems. This practice aims to bring about an equally wide-ranging degree of benefits in both the short-term and the long-term for the software itself and for organizations that sponsor such software. Software engineering practitioners regard components as part of the starting platform for service-orientation. Components play this role, for example, in web services, and more recently, in service-oriented architectures (SOA), whereby a component is converted by the web service into a ''service'' and subsequently inherits further characteristics beyond that of an ordinary component. Components can produce or ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Data Validation
In computer science, data validation is the process of ensuring data has undergone data cleansing to ensure they have data quality, that is, that they are both correct and useful. It uses routines, often called "validation rules", "validation constraints", or "check routines", that check for correctness, meaningfulness, and security of data that are input to the system. The rules may be implemented through the automated facilities of a data dictionary, or by the inclusion of explicit application program validation logic of the computer and its application. This is distinct from formal verification, which attempts to prove or disprove the correctness of algorithms for implementing a specification or property. Overview Data validation is intended to provide certain well-defined guarantees for fitness and consistency of data in an application or automated system. Data validation rules can be defined and designed using various methodologies, and be deployed in various contexts. Thei ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Electronic Data Capture
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). Typically, EDC systems provide: * a graphical user interface component for data entry * a validation component to check user data * a reporting tool for analysis of the collected data EDC systems are used by life sciences organizations, broadly defined as the pharmaceutical, medical device and biotechnology industries in all aspects of clinical research, but are particularly beneficial for late-phase (phase III-IV) studies and pharmacovigilance and post-market safety surveillance. EDC can increase data accuracy and decrease the time to collect data f ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Data Acquisition
Acquisition or collection of clinical trial data can be achieved through various methods that may include, but are not limited to, any of the following: paper or electronic medical records, paper forms completed at a site, interactive voice response systems, local electronic data capture systems, or central web based systems. There is arguably no more important document than the instrument that is used to acquire the data from the clinical trial with the exception of the protocol, which specifies the conduct of that clinical trial. The quality of the data collected relies first and foremost on the quality of that instrument. No matter how much time and effort go into conducting the clinical trial, if the correct data points were not collected, a meaningful analysis may not be possible. It follows, therefore, that the design, development and quality assurance of such an instrument must be given the utmost attention. The ICH guidelines on good clinical practice (GCP) use the term ‘ ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Electronic Data Capture
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). Typically, EDC systems provide: * a graphical user interface component for data entry * a validation component to check user data * a reporting tool for analysis of the collected data EDC systems are used by life sciences organizations, broadly defined as the pharmaceutical, medical device and biotechnology industries in all aspects of clinical research, but are particularly beneficial for late-phase (phase III-IV) studies and pharmacovigilance and post-market safety surveillance. EDC can increase data accuracy and decrease the time to collect data f ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Research
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. Overview The term "clinical research" refers to the entire bibliography of a drug/device/biologic, in fact any test article from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the test article (including its safety toxicity if applicable and efficacy, if possible at this early stage) are studied. In the United States ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmaceutical Industry
The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications to be administered to patients (or self-administered), with the aim to cure them, vaccinate them, or alleviate symptoms. Pharmaceutical companies may deal in generic or brand medications and medical devices. They are subject to a variety of laws and regulations that govern the patenting, testing, safety, efficacy using drug testing and marketing of drugs. The global pharmaceuticals market produced treatments worth $1,228.45 billion in 2020 and showed a compound annual growth rate (CAGR) of 1.8%. History Mid-1800s – 1945: From botanicals to the first synthetic drugs The modern era of pharmaceutical industry began with local apothecaries that expanded from their traditional role of distributing botanical drugs such as morphine and quinine to wholesale manufacture in the mid-1800s, and from discoveries resulting from applied research. Intentional drug ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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