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In such CDMSs, the investigators directly upload the data on CDMS, and the data can then be viewed by the data validation staff. Once the data are uploaded by site, the data validation team can send the electronic alerts to sites if there are any problems. Such systems eliminate paper usage in clinical trial validation of data.
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 ...
HITRUST is a privately held for-profit company located in Frisco, Texas, United States. It is solely owned by Daniel S. Nutkis who is the President and CEO. HITRUST in collaboration with healthcare, technology and information security organizations, established the HITRUST CSF. The company claims CSF is a comprehensive, prescriptive, and ...
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.
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. [1] EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drugs and medical devices.
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]
NextGen Healthcare, Inc. is an American software and services company headquartered in Atlanta, Georgia. The company develops and sells electronic health record (EHR) software and practice management systems to the healthcare industry , as part of a range of software, services and analytics solutions for medical and dental practices.
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.