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Pamrevlumab (INN; [1] development code FG-3019) is a humanized monoclonal antibody designed for the treatment of idiopathic pulmonary fibrosis and pancreatic cancer. It binds to the connective tissue growth factor (CTGF) protein.
In drug development, preclinical development (also termed preclinical studies or nonclinical studies) is a stage of research that begins before clinical trials (testing in humans) and during which important feasibility, iterative testing and drug safety data are collected, typically in laboratory animals.
Similar to clinical research, preregistration can help to improve transparency and quality of research data in preclinical research. [46] [47] In contrast to clinical research where preregistration is mandatory for vast parts it is still new in preclinical research. A large part of preclinical and basic biomedical research relies on animal ...
Accurate computer models of a treatment and its deployment, as well as patient characteristics, are necessary precursors for the development of in silico clinical trials. [5] [6] [8] [9] In such a scenario, ‘virtual’ patients would be given a ‘virtual’ treatment, enabling observation through a computer simulation of how the candidate biomedical product performs and whether it produces ...
The data management plan describes the activities to be conducted in the course of processing data. Key topics to cover include the SOPs to be followed, the clinical data management system (CDMS) to be used, description of data sources, data handling processes, data transfer formats and process, and quality control procedure
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 ...
For example, software used to transmit data from a medical device, or software that analyzes data from a medical device and makes diagnostic or treatment decisions normally made by a physician, would be considered software regulated as a medical device. A product that only stores and displays patient information is not a medical device.
Janus clinical trial data repository is a clinical trial data repository (or data warehouse) standard as sanctioned by the U.S. Food and Drug Administration (FDA). It was named for the Roman god Janus (mythology) , who had two faces, one that could see in the past and one that could see in the future.