Tag Archives: Clinical Trial

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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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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11 CONSIDERATIONS IN CHOOSING THE RIGHT CLINICAL TRIAL SITES


Dr Michael Silverman, principal at BioStrategics Consulting Ltd, discusses clinical trial site selection and its impact on operational success. When we consider operational success, there are two distinct aspects: Getting the Right Data and Getting the Data Right. The first … 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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