Tag Archives: FDA

CLINICAL DEVELOPMENT: THE CLINICAL TRIAL CASE REPORT FORM AND CLINICAL TRIAL MONITORING


A key aspect of clinical development and clinical trial operational success is getting the data right. Dr Michael Silverman, principal at BioStrategics Consulting Ltd., discusses the importance of the Case Report Form and Clinical Monitoring to ensure the quality of … Continue reading

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CLINICAL DEVELOPMENT: THE CLINICAL TRIAL SAMPLE SIZE


Dr Michael Silverman, principal at BioStrategics Consulting Ltd, discusses clinical trial sample size as an important aspect of the clinical trial protocol. This week I would like to discuss certain considerations around clinical trial sample size in defining a successful … Continue reading

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CLINICAL DEVELOPMENT: CLINICAL TRIAL DESIGN


Dr Michael Silverman, principal at BioStrategics Consulting Ltd, discusses clinical trial design as an important aspect of the Clinical Trial Protocol. This week I would like to discuss the importance of clinical trial design in defining a successful clinical trial … Continue reading

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Clinical Development: The Clinical Trial Protocol Patient Population


Dr Michael Silverman, principal at BioStrategics Consulting Ltd, continues his discussion this week on the Clinical Trial Protocol. To achieve a successful protocol, the choice of the patient population is critical. This week I would like to discuss a make … Continue reading

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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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