Clinical Operations-Design to Execution

BayBiotech.NET Recent FDA Amendments Act of 2007 has emphasized needs of active adverse event surveillance methods linking multiple sources of clinical data for analysis and further mandates creation of effective tools for post market risk identification, assessment and management of adverse events. Legislation recognizes the limitations of traditional mainstream drug safety practices in the pharmaceutical industry that depends on the collection and analysis of safety data from clinical trials and therefore emphasizes the need of data mining from multiple sources. In past few years, emerging need of data mining has generated lot of interest among various competitors to develop tools within the limits of privacy and confidentiality limits to meet the drug safety needs. FDA is in the process of currently exploring, testing, and developing new methods of signal detection, data mining, and analysis of patient-level electronic healthcare data hoping that these new developed methods will...

BayBiotech.NET Following is a summary of the key points on the laws, regulations and Good Clinical Practices of the Member States as per European Union’s Directive for conduct of Clinical Trials on human subjects: 1. Directive requires that applications for authorization to place a medicinal product on the market should be accompanied by a dossier containing particulars and documents relating to the results of tests and clinical trials carried out on the product. A dossier must be prepared in compliance with uniform rules laid down by the Member States. 2. A detailed risk assessment and management strategy must be in place based on the toxicological data derived at Pre-clinical research stage. 3. Persons who are incapable of giving legal consent such as dementia, psychiatric patients etc. to clinical trials should be given special protection. Such persons may not be included in clinical trials if the same results can be obtained using persons capable of giving consent. These...