Category Archives: Medical

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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Ensuring Clinical Trial Data Quality


A key aspect of clinical trial operational success is getting the right data. Dr Michael Silverman, principal at BioStrategics Consulting Ltd., discusses managing clinical assessments and laboratory procedures to ensure the quality of data acquisition. Last week I discussed operational … 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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Placebo-Controlled Clinical Trials. Are They Still Relevant?


Dr Michael Silverman of BioStrategics Consulting Ltd raises the question and discusses the relevance of placebo-controlled clinical studies in medicine and drug development today. Of course a placebo-controlled study is far superior in addressing the question of does your drug … Continue reading

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