Biostatistics Featured Articles
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Quality Of Outsourced Trials: Why Do Disconnects Still Exist Between Sponsors And CROs
7/14/2015
The requirement for quality during the conduct of clinical trials is an absolute; a given that few in the pharmaceutical, biotech, and CRO industries would debate. Yet longitudinal survey data collected by The Avoca Group highlight that disconnects - the definitions of what constitutes quality, alignment on required levels of quality, and success at delivering to these expectations - continue to exist. Business models for designing and implementing clinical trials require that multiple stakeholder organizations (e.g. pharma/biotech, CROs, co-development partners, and regulators) align on and successfully implement to mutually agreed quality expectations.
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Theory Of Constraints: A Scientific Approach To Management
4/17/2013
The Theory of Constraints (TOC) is a unique management philosophy that strives for a rationale or scientific approach to management. It provides a way to simplify the complexity of human-based systems and still keep the main issues and impacts under managerial control. By Christopher Hurley, MBA, Manager, Clinical Programming & Biostatistics
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Former Acorda Chief Medical Officer Discusses Benefits And Pitfalls Of Outsourcing
3/18/2013
Dr. Thomas C. Wessel, former chief medical officer for Acorda Therapeutics, recently shares his expertise acquired from working with the clinical development and operations, regulatory affairs, biostatistics, data management and drug safety functions.
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Expert Insight Into ePRO Industry Trends
6/7/2012
As technologically savvy as we think we have become, there are still plenty of studies being conducted via pen and paper. By Rob Wright