Regulatory Insights

  1. How NOT To Respond To An FDA Warning Letter
    5/14/2013

    Has your company received an FDA warning letter? A proper response is critical and may mean the difference between whether the FDA accepts your response or determines that additional action is required. When crafting your response, make sure you do not make a bad situation worse by engaging in any of these mistakes.

  2. Beyond EDC: Resolving Data-Entry Challenges Faced By Electronic Data Capture Systems In Clinical Trials
    5/8/2013

    Electronic Data Capture (EDC) systems have swept the Clinical Trials industry in recent years, promising to transform the drug development process.

  3. Military Drug Trials Group Eliminates Errors And Inefficiencies Using Electronic Data Capture And Tablet PCs
    5/8/2013

    Infectious Disease Clinical Research Program (IDCRP) is a worldwide network of Department of Defense (DoD) clinical and research centers that have collaborated to investigate infectious disease challenges facing the military.

  4. Switching EDC Platforms To Rescue In-Flight Clinical Trials
    5/7/2013

    The decision to switch an EDC platform for in-flight trials is not easy and is fraught with risks. A majority of companies continue to plough forward with higher costs and operational pains due to a failing EDC platform. Read this white paper and learn how Acceliant's low-risk EDC migration can deliver legacy EDC retirement, lower operating costs, and peace of mind for all teams working towards the success of a clinical trial. By Ven Thangaraj, CTO, Acceliant

  5. New Molecular Entities (NMEs) The Path Of Resistance
    5/3/2013

    On a global scale, the number of new molecular entities (NMEs) in development—and, more importantly, the number being approved by regulatory authorities— has dropped significantly in recent years.

  6. Moving Towards An Electronic Environment In Clinical Trials
    5/3/2013

    With each passing year, clinical trials are becoming increasingly global. The business of product development is moving away from the traditional model in which studies are conducted primarily in the US – in fact, recent estimates indicate that within the next three years, up to 65 per cent of studies under FDA regulation will be conducted outside the US. A review of a US government clinical trials registry and of 300 published reports in major medical journals revealed that one third (157 of 509) of Phase III trials were being conducted entirely outside the US, with over half the study sites (13,521 of 24,206) used in these trials located overseas, many in eastern Europe and Asia.

  7. 33 Questions To Ask Before Buying Data Management Software
    4/30/2013

    While choosing the wrong product is never a good idea, when it comes to clinical trials software, the wrong product could be disastrous for your company.

  8. Interviewer: Questions To Ask During An Interview
    4/29/2013

    If you’re like me and most people I’ve talked to, interviewing on either side of the table can be a daunting and arduous task. By Peggy Berry, Pharma Interactive Training Courses, www.phitcourses.com

  9. The Sunshine Act - It's Finally ‘Official’
    4/19/2013

    So now that the long wait is over for the final rule, where do you go from here? On February 8th, 2013 the final rule of the Physician Payment Sunshine Provision (PPSP aka "Sunshine Act") was released by The Centers for Medicare and Medicaid Services (CMS). By Kevin Williams

  10. 5 Reasons To Synergize CTA Negotiations And Essential Document Collection
    4/19/2013

    The contractual and regulatory landscapes are ever-changing, increasingly complex and study timelines just keep getting shorter. By Rebecca Arch