Biostatistics Featured Articles

51. How One Bio Company Tackled Its Data Visualization Challenge 7/16/2015

    Data visualization is a problem for many life science companies. Being able to visualize reliable data in real-time, and make smarter decisions faster, is vital to delivering speed and quality across clinical trials.

    While many companies struggle with quality uncertainty and surfacing relevant data trends, those that specialize in rare diseases have a more unique challenge. With rare diseases, trials are open label (patients and researchers both know which drug is being administered) and non-comparative. By design, personnel have access to data in an unblended way. That provides the opportunity to see actual data as it emerges, enabling personnel to understand the data in a way that would not be possible in a blended trial.

52. 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. 

53. Lilly's Approach To The Clinical Trial Paradox 2/2/2014

    When I sat down with Eli Lilly (NYSE: LLY) and Company’s chief medical officer and coleader of the company’s Development Center of Excellence, Timothy Garnett, it was shortly after the drugmaker’s annual investment community meeting where bankers grilled the leadership team with questions.

54. 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.

55. 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

56. 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.

57. 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?

58. 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

59. 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