Biostatistics Featured Articles

  1. Clinical Leader Expands Editorial Advisory Board 12/17/2015

    Clinical Leader relies on the feedback of pharma industry professionals and consultants to guide its focus and direction. The website’s editorial advisory board, composed of consultants and executives from the pharma and bio industries, help guide the direction and focus of the site’s editorial content. Clinical Leader has announced that in 2015 it added 17 distinguished individuals to that board, including representatives of Eli Lilly and Company, Pfizer, The Avoca Group, PatientsLikeMe, BMS, Novartis, Shire, and more.

  2. The Challenge Of Vendor Selection, Cost Overruns, And Change Orders 10/23/2015

    If you are in charge of clinical operations for a small pharma or bio company, you are likely very familiar with the challenges and frustrations associated with vendor selection, vendor management, timeliness, cost overruns, and change orders. I recently had the opportunity to speak with the director of clinical operations for a small pharma company that currently has assets in Phase 1 trials. Although he has spent a good amount of his 20-year pharma career working in Big Pharma, he was able to give me a nice perspective of the challenges he faces in his current company, and how he is attempting to overcome them.

  3. 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.

  4. 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.

  5. Eli Lilly Research Lab Tour Reveals More Than Meets The Eye 11/1/2013

    Lilly Research laboratories (LRL) opened doors to a select group of media for a rare behind-the-scenes tour of three new innovation labs.

  6. 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

  7. 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.

  8. Overcoming Common Missteps In Clinical Trials 12/28/2012

    What steps you can take to overcome the most common problems in clinical trials such as, study designs and lack of sufficient exploration into study conduct processes that could affect the analyses and interpretation?

  9. 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

  10. FDA's New Guidance On Clinical Monitoring Arrives 9/6/2011
    The FDA has released its long awaited update and replacement to the outdated 1988 guidance on clinical monitoring. The draft guidance for industry on Oversight of Clinical Investigations - A Risk Based Approach to Monitoring is early evidence that the findings and recommendations of the Clinical Trials Transformation Initiative (CTTI), FDA's public-private partnership with Duke University among others, are beginning to take hold in practice in the clinical trials domain. By Jacquie Wiebe Mardell