Regulatory Insights

  1. Switching EDC Platforms To Rescue In-Flight Clinical Trials

    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

  2. New Molecular Entities (NMEs) The Path Of Resistance

    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.

  3. Moving Towards An Electronic Environment In Clinical Trials

    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.

  4. 33 Questions To Ask Before Buying Data Management Software

    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.

  5. Interviewer: Questions To Ask During An Interview

    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,

  6. The Sunshine Act - It's Finally ‘Official’

    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

  7. 5 Reasons To Synergize CTA Negotiations And Essential Document Collection

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

  8. Toxicometabolomics For Compound Attrition To Reduce Late Stage Failures Due To Safety

    Many ’omics’ technologies have now become the primary way of discovering new biomarkers, and validation of these biomarkers is a relatively new and evolving concept. By Michael V. Milburn, John A. Ryals, and Lining Guo

  9. MHRA’s Summary Of PV Systems (SPS) Document

    As everyone who deals with the EU and the UK in drug safety knows, the EMA issued a new set of Good PV Guidelines to replace (largely) Volume 9A. By Bart Cobert

  10. MHRA’s Compliance Report

    On February 5, 2013, the MHRA put out an update bulletin on its “Compliance Report”. The Compliance Report from the MHRA began around 2009 when they moved to a risk based pharmacovigilance (PV) inspection process. By Bart Cobert