Insights On Trial Design

  1. Effect Of Hemolysis, Icterus And Lipemia On Chemistry Tests And Association Between The Amount Of Interfering Substances And LIH Indices
    11/2/2018

    An evaluation of the effect of hemolysis, icterus and lipemia on chemistry assays and further assessment of the association between the amount of interfering substances and ordinal values reported by the automated chemistry analyzer as H-, I- and L-indices.

  2. Diabetic Foot Infections: Opportunities And Challenges In Clinical Research
    11/2/2018

    Research in diagnosis, management, and therapy development, as well as development of standardized guidelines for upcoming studies need to be addressed in order to improve the prognosis of DFI patients.

  3. Meeting The EU CTR Compliance Challenge Head-On
    10/31/2018

    A TrialScope analysis of 16,000+ clinical trials posted on EU CTR revealed many common errors.

  4. Clinical Trial Websites: Challenging The Status Quo
    10/31/2018

    See how to implement digital best practices and good design principles to boost transparency and patient engagement efforts.

  5. The Microbiome In Clinical Trials: Opportunities And Challenges
    10/31/2018

    In order to increase the number of potentially successful clinical development projects in the microbiome space, it will be important to recognize standard drug development principles and global drug or biologic development requirements.

  6. The Role Of The CRO In Effective Risk-Based Monitoring
    10/31/2018

    A CRO with deep therapeutic, regulatory and operational expertise facilitates the risk-assessment process by highlighting items within the protocol design that have the potential to impact overall risk levels. Identifying these risks and potential operational challenges early in the process is essential to the success of RBM later in the study.

  7. Replacing The TQT With Exposure-QT Response Study
    10/31/2018

    Revised study now includes the opportunity to demonstrate the cardiac safety of a new drug by utilizing Exposure-QT response study data in dose escalation and other studies.

  8. Personalized Medicine In Oncology And The Implication For Clinical Development
    10/31/2018

    Obstacles still remain in developing effective and efficient new targeted therapy agents, identifying the biomarker tests that indicate which patients will be responsive to them, and implementing them in clinical practice.

     

  9. Adaptive Trial Design and Implementation
    10/31/2018

    Understand the concept and benefits of adaptive trials and if they should be a consideration for your company.

  10. Non Invasive Biomarkers Of Non-Alcoholic Steatohepatitis And Liver Fibrosis
    10/31/2018

    Understanding the non-invasive methods for assessing fibrosis range from biomarker assays to advanced imaging techniques such as transient elastography.