Monthly Archives: June 2011

Clinical Trial Probability of Success? Just How Probable Is A Great Outcome.


The cost and time of well-designed clinical trials is growing rapidly, but just how probable is it that the data will be sufficient to support regulatory approval and market success? Dr Michael Silverman, principal at BioStrategics Consulting Ltd., discusses the … Continue reading

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Clinical Trial Success: How Do You Define Success?


When you complete your clinical trial and review the results, how do you define success? Dr Michael Silverman, principal at BioStrategics Consulting Ltd., discusses the different aspects and relevance of clinical trial success. The study is complete. All patients have … Continue reading

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CLINICAL DEVELOPMENT: CLINICAL TRIAL DATA MANAGEMENT, STATISTICAL PROGRAMMING AND ANALYSIS, AND QUALITY ASSURANCE


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 Data Management, the Statistical Programming and Analysis, and the Quality Assurance activities. … Continue reading

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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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