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Clinical trial management system. 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 ...
A trial master file contains essential documents for a clinical trial that may be subject to regulatory agency oversight. In the European Union (EU), TMFs have a different definition and set of requirements than in the US. The EU Commission's Directive 2005/28/EC 63 Chapter 4 states 'the trial master file shall consist of essential documents ...
A contract manufacturing organization (CMO), more recently referred to (and more commonly used now) 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 ...
Phase 0 of a clinical trial is done with a very small number of people, usually fewer than 15. Investigators use a very small dose of medication to make sure it isn’t harmful to humans before ...
An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.
A project management information system (PMIS) is the logical organization of the information required for an organization to execute projects successfully. A PMIS is typically one or more software applications and a methodical process for collecting and using project information. These electronic systems "help [to] plan, execute, and close ...
Project management software are computer programs that help plan, organize, and manage resources.. Depending on the sophistication of the software, it can manage estimation and planning, scheduling, cost control, budget management, resource allocation, collaboration software, communication, decision-making, quality management, time management and documentation or administration systems.
Business and economics portal. v. t. e. Project management is the process of supervising the work of a team to achieve all project goals within the given constraints. [1] This information is usually described in project documentation, created at the beginning of the development process. The primary constraints are scope, time, and budget. [2]
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