White Papers

  1. New Paradigms In Alzheimer’s Research: Reviving The Treatment Landscape
    1/19/2017

    Scientists hypothesize, but cannot definitively prove, that tangles of tau protein and build-ups of beta-amyloid plaque contribute to the hallmark cognitive decline of Alzheimer’s disease. Without a definitive cause or diagnosis – and no cure in sight – many aging adults see no reason to assess their risk, or determine their cognitive status, if little can be done to stave off the disease. Perceptions such as these present a growing challenge to Alzheimer’s research. Understanding these clinical research barriers is critical to developing strategies to overcome them.

  2. Four Steps For Reducing The Risks Of Temperature Excursion
    1/11/2017

    In clinical trials, the cold chain is far from a secondary concern. When it comes to temperature-sensitive products (tissue samples, cell banks, APIs), any temperature excursion can prove detrimental to the shipment, and ultimately to the trial. Supply chains are not always predictable or easy to control, and pharma companies need to take a proactive approach to risk management. Sue Lee, technical portfolio manager at World Courier, explains how companies can determine their risks and plan a shipment strategy accordingly.

  3. Maintaining Integrity Of The Supply Chain
    1/11/2017

    The cost associated with counterfeit drugs is staggering - both in human and commercial terms. In some cases, patients are deprived of treatment for diseases and conditions that range from mild to severe to life-threatening. In other cases, they are harmed by dangerous substances in the product, or become resistant to traditional therapeutic treatments or vaccines. In all cases, the public loses confidence in the companies that develop these drugs and in the very agencies that have been established to protect them.

  4. Does ICH E6 R2 Effect Risk-Based Monitoring And Overall Quality Risk Management?
    1/11/2017

    Regulators are encouraging the industry to take a new quality risk management (QRM) approach to clinical trial execution. The latest International Council for Harmonisation (ICH) Good Clinical Practice (GCP) E6 R2 guidelines represent the first update to the guidelines in over 19 years.

  5. Maximize The ROI Of Your Post-Approval Research
    1/10/2017

    If your business is like many other pharmaceutical, biotech or medical device companies, your investments in post-approval research are steadily increasing. Discover how to harness the power of post-approval research to increase data collection, reduce resource burn, save money, and maximize your ROI!

  6. CRO’s And The Clinical Supply Chain – It’s Not Just A Label On A Box
    12/20/2016

    Typically Clinical Research Organisations (CRO’s) involvement in the Clinical Trial process has centered on site management in terms of identifying potential sites and managing patient recruitment.

  7. Clinical Trials Breathe Life Into Standard Operating Procedures (SOPs)
    12/12/2016

    Standard Operating Procedures (SOPs) have long been fundamental to many industries, and the clinical trials sector is no exception. With the advent of the Good Clinical Practice Guideline in 1996 from the International Conference on Harmonisation (ICH-GCP), stakeholders have been motivated to develop SOPs, not only for regulatory compliance, but also as a routine business practice. SOPs are defined in the GCP Guideline as detailed, written instructions needed to achieve consistent performance for a specific function,1 with a goal of instilling quality into clinical trial operations. Yet, too often, after companies devote significant time and resources into creating SOPs, they may not be followed. They may be ignored or even avoided.

  8. Clinical Study Leader Or Laggard?
    12/12/2016

    Quality management and competitive edge are vital to the clinical trials sector and are fueling widespread use of purpose-built technology. Cloud-based solutions, such as clinical trial management systems (CTMS) and the electronic trial master file (eTMF), are broadly accepted, but these tools fail to address study startup (SSU), a complex set of processes that contribute heavily to lengthy timelines, often lasting seven years. With greater globalization of clinical trials and factors ranging from site selection to regulatory document submission to enrolling the first patient, assessing SSU status is critical. It pinpoints bottlenecks and areas of risk that could impact data quality and derail study budgets and timelines.

  9. Deep Knowledge Of Clinical Study Startup Points Data In Right Direction
    12/12/2016

    Purpose-built SSU solutions track clinical trial operations using much needed standardized performance metrics.

  10. Modern Risk Management In Global Pharmaceutical Logistics
    12/7/2016

    Everything pharmaceutical manufacturers want to know about risk in supply chain logistics but are afraid to ask. What are the rising trends impacting security of product in transport? When and where does risk mitigation become mission critical? And — perhaps the most burdensome — how can I be sure?