Monthly Archives: April 2011

Clinical Development: The Clinical Trial Protocol


Dr Michael Silverman, principal at BioStrategics Consulting Ltd, initiates a discussion this week on the Clinical Trial Protocol. The protocol to test one’s product, to confirm or reject a specific hypothesis, is key in the Clinical Development Plan and in … Continue reading

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Clinical Trials: The Clinical Development Plan Part 2


Dr Michael Silverman, principal at BioStrategics Consulting Ltd, continues the discussion this week on the formulation of a Clinical Development Plan. This is a vital road map defining how one’s product will be developed through a series of clinical trials … Continue reading

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Clinical Trials: The Clinical Development Plan Pt 1


Dr Michael Silverman, principal at BioStrategics Consulting Ltd, talks about a second important strategic element of pharmaceutical development in this blog, and that is, the formulation of a Clinical Development Plan. This is a vital road map defining how the … Continue reading

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Clinical Trials: Crafting the Label


Dr Michael Silverman, principal at BioStrategics Consulting Ltd, talks about an important strategic element of clinical trial design and pharmaceutical development in this blog, and that is, the crafting of the product label. This is the defining document for how … Continue reading

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