BioStrategics Consulting Ltd provides its services through its President and Senior Clinical Development Consultant, Michael H Silverman, MD, FACP. Since 1999, BioStrategics Consulting Ltd has been providing strategic, management-level clinical development consulting services to companies around the world, including North America, Europe, Asia, and New Zealand. Foremost amongst these services is consulting related to clinical development program strategy, planning, and operations. This encompasses assistance to companies in creating long-term clinical development plans; conceptualizing and creating clinical protocols for Phase 1, Phase 2, and Phase 3 trials; evaluating, selecting, and overseeing clinical contract research organizations; and interacting with FDA and other regulatory authorities regarding the clinical program. Dr Silverman also personally assists with operational aspects of these clinical trials, especially medical monitoring and safety oversight; and actively participates in data review, analysis, reporting, and publication.
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.
For More Information: Visit the BioStrategics Website at www.biostrategics.com
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