Clinical Operations-Design to Execution

BayBiotech.NET The Medpedia Project has established a platform ‘Medpedia Clinical Trials’ for patients, researchers and physicians to receive information about the thousands of clinical trials that are in process or about to begin worldwide. The information on various clinical trials is updated regularly from ClinicalTrials.gov and can be searched using different attributes with basic and advanced search functionalities. Medpedia Clinical Trials platform allows visitors to leave their comments, thoughts and views on a specific clinical trial page. Most importantly, a personalized feed can also be obtained if someone is interested in learning more about on-going or about to start clinical trials on a particular condition worldwide. Moreover, if you are reading a Medpedia article on a particular clinical condition, the information on the related clinical trials are fed automatically alongside the article page. To learn more about it visit http://www.medpedia.com/clinical-trials .

BayBiotech.NET As per ICH guidelines, the overall aim of an Investigator’s Brochure is to provide the investigator with a clear understanding of the possible risks and adverse reactions, and of specific tests, observations and precautions that may be needed to conduct a clinical trial maintaining the safety of the patients enrolled for the study. This information must be based on scientific data produced by performed physical, chemical, pharmaceutical, pharmacological, toxicological, and clinical information of the investigational drug or device. Based on the scientific studies, the Investigator’s Brochure is intended to provide the Investigator with necessary management of study subjects throughout the clinical trial. Main focus must be given to the following measures: A. Dose B. Frequency of the dose C. Method of administration D. Safety monitoring procedures E. List of abbreviations and acronyms F. Description of the formulation of the drug G. Instructions for the storage ...