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The analysed data are compiled into clinical study report and sent to the regulatory authorities for approval. Most of the drug manufacturing companies are using Web-based systems for capturing, managing and reporting clinical data. This not only helps them in faster and more efficient data capture, but also speeds up the process of drug ...
Gathers data from data managers (anyone involved in data management activity for developing drugs) from the pharmaceutical industry, CROs, software vendors or universities. The French network of data managers in academic biomedical research (AcaDM) is a network founded in 2008 which aims to offer a space for reflection between experts in order ...
The Fast Healthcare Interoperability Resources (FHIR, / f aɪər /, like fire) standard is a set of rules and specifications for the secure exchange of electronic health care data. It is designed to be flexible and adaptable, so that it can be used in a wide range of settings and with different health care information systems.
Good clinical data management practice (GCDMP) is the current industry standards for clinical data management that consist of best business practice and acceptable regulatory standards. In all phases of clinical trials , clinical and laboratory information must be collected and converted to digital form for analysis and reporting purposes.
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.
Experts expect price hikes would lead some Americans to drop their coverage, while others would downgrade to cheaper plans. The Congressional Budget Office estimates that in total, 3 million more ...
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. [1]
The Online Safety Act, which became law last year, sets tougher standards for platforms such as Facebook, YouTube and TikTok, with an emphasis on child protection and the removal of illegal content.