Monthly Archives: January 2011

BioStrategics Consulting Ltd Consulting Experiences and Ideal Business Clients.


Dr Michael Silverman talks about some of the clinical experiences of BioStrategics Consulting Ltd and what he describes as his ideal business clients. BioStrategics Consulting Ltd provides its services through its President and Senior Clinical Development Consultant, Michael H Silverman, … Continue reading

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New FDA Safety Requirements: Question on timing and how it affects current INDs and clinical studies


Dr. Shailesh C. Comment and Question: “Excellent comments. I completely agree that the new guidance on safety reporting helps Sponsor’s on better judgment and possibility to make better assessments. It means Sponsor’s have to monitor the clinical studies, any post … Continue reading

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New FDA Clinical Study Safety Monitoring Requirements


Michael Silverman comments on the new FDA Clinical Study Safety Monitoring Requirements including the ability to evaluate events in context and the new definition of unexpected events I’ve come a little late to the topic, but I’m now studying up … Continue reading

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BioStrategics Consulting Ltd Explains some of its Clinical Development Services


Dr Silverman explains some of BioStrategics Consulting Ltd clinical development services: 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 … Continue reading

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“Doing it right” in Phase 2 clinical trials


“Doing it right” in Phase 2 clinical trials: When I was young in the pharmaceutical industry, I was on a job interview when I first heard a catchphrase that eloquently captures an attitude that one encounters every so often in … Continue reading

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BioStrategics Consulting Ltd Introduces its President and Senior Clinical Development Consultant, Michael H. Silverman, MD, FACP.


BioStrategics Consulting Ltd provides its services through its President and Senior Clinical Development Consultant, Michael H Silverman, MD, FACP. Dr Silverman received his medical education at the University of Chicago Pritzker School of Medicine and is doubly Board-Certified in Internal … Continue reading

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BioStrategics Consulting Ltd Launches New Blog Site for Companies Contemplating Clinical Development of Their Medical Products.


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 … Continue reading

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