BioStrategics Consulting Ltd provides a range of management-level clinical development consulting services to the pharmaceutical, biotechnology and medical device industries. The goal of this blog is to provide a forum to discuss the challenges and intricacies of clinical development, as well as the testing of pharmaceutical, biotechnology and medical device products in man. As these endeavors can take many years and cost millions of dollars, a great deal of thought has to go into them before embarking on any given clinical study. There are a multitude of considerations including the safety of the product, the target population, what effects it is likely to induce, what specific outcomes one hopes for, needs to look for, and to measure. What does the FDA expect? What type of approval is needed before any studies can be performed? What will the eventual label look like? A myriad of operational factors also come into play, including statistical planning and analysis; data management; clinical monitoring; pharmacovigilance; and report writing.
Over the next several months, I hope to address these subjects and others that are of interest to you (and me). If you have any particular questions you would like me to address, send me an email at email@example.com
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