Biostatistics Featured Articles

11. Five P's For A Productive CRO Relationship 9/18/2015

    You have done the research and selected a CRO that looks like it can meet all your research needs. Now you are about to entrust your precious samples to a team of people you may barely know. How do you safeguard your research, meet your timelines, and develop a productive working relationship with your CRO? Few things are less stressful than managing these relationships. A good CRO can bring your project in on time, meet all regulatory requirements, and do so with the level of quality you expect. Unfortunately, choosing the wrong CRO can result in delays, poor quality, and the feeling that you have a CRO that will require constant monitoring and hand-holding.

12. Is The Sunshine Act Reducing Clinical Research Spending? 8/24/2015

    The intentions behind the passing of the Physicians Payment Sunshine Act were good. The Act required manufacturers of covered drugs, devices, biological products, and medical supplies to annually report to the Centers for Medicare & Medicaid Services (CMS) information regarding payments, ownership, investment interests, and other transfers of value to physicians and teaching hospitals. The intent was to reveal any conflicts of interest that might exist, with the end goal of hopefully bringing down healthcare costs. But even the most well-intentioned acts can have unforeseeable negative results. And it now seems the well-intentioned Sunshine Act may be having the unintended consequence of cutting down on the amount of investment making its way into clinical trials.

13. 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

14. 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.

15. 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