Search results
Results From The WOW.Com Content Network
CLARIO formerly ERT and Bioclinica [2] is a technology company specializing in clinical services and customizable medical devices to biopharmaceutical and healthcare organizations. It offers centralized cardiac safety and respiratory efficacy services in drug development and also collects, analyzes and distributes electronic patient-reported ...
An electronic patient-reported outcome (ePRO) is a patient-reported outcome that is collected by electronic methods. ePRO methods are most commonly used in clinical trials, but they are also used elsewhere in health care.
The leading cause of missed clinical trial deadlines is patient recruitment, taking up to 30 percent of the clinical timeline. [3] Improving patient recruitment rates offers pharmaceutical and medical device companies one of the biggest opportunities to accelerate the pace of clinical trials – making it possible to reduce time to market. As ...
Often, a clinical trial management system provides data to a business intelligence system, which acts as a digital dashboard for trial managers. [5] [6] [7] CTMSs allow experts easily to access centralized data and thus reducing the number of delayed trials. Sponsors can work with a database of previously researched contacts and names of ...
Acronyms were first used to identify clinical trials in the 1970s. [5] The first identified instance was "UGDP", an initialism for University Group Diabetes Program. The first trial title commonly pronounced as an English-language word or words came in 1982 with the publication of "MRFIT", referring to the Multiple Risk Factor Intervention Trial, and spoken as "Mr. Fit" or "the Mr. Fit trial".
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 ...
Clinical endpoints or clinical outcomes are outcome measures referring to occurrence of disease, symptom, sign or laboratory abnormality constituting a target outcome in clinical research trials. The term may also refer to any disease or sign that strongly motivates withdrawal of an individual or entity from the trial, then often termed a ...
This time interval should take into account the expected clinical benefit that such a status may bring to the population under study. Response review For trials where the response rate is the primary endpoint it is strongly recommended that all responses be reviewed by an expert(s) independent of the study at the study's completion.