White Papers

  1. Managing eCOA Data: Principles & Best Practices For Data Managers
    4/21/2017

    With the quality of data captured throughout a trial playing a crucial role for the success or failure of a study, clinical data management (CDM) is a key element of any research program. During a study lifecycle, data managers will deal with data from many sources such as MRI scans, ECG, lab data, as well as eCOA – all of which are equally important. 

  2. Mobile Apps: A 360° Guide For Clinical Trials
    4/7/2017

    This paper isolates three specific areas that warrant close attention for app developers, clinical trials sponsors and CROs designing trials powered with mHealth app tools: technology considerations, data considerations and regulatory considerations. These areas are vital to developing a compliant trial that generates meaningful data for clinical development using mHealth sources.

  3. Applying An Innovative Mindset To Post-Approval Research
    3/30/2017

    Post-approval research studies are becoming increasingly large and complex in the clinical research landscape. These programs are often massive in scope, engaging thousands of physicians and tens of thousands of patients. Unfortunately, post-approval operational strategies have not kept pace with the needs and demands of post-approval (Phase IV) research.

  4. Reducing The Burden Of Data Collection In Oncology Trials
    3/3/2017

    Understanding patient reported outcomes (PROs) in oncology clinical trials enables researchers to develop more effective treatments for patients battling this illness. But if it isn't easy for patients to report their health data, they won't - so it must be accessible for them.

  5. 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.

  6. 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.

  7. 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.

  8. 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!

  9. 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.

  10. 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. Yet, too often, after companies devote significant time and resources into creating SOPs, they may not be followed.