Clinical Leader Webinar

  1. eConsent: The Good, The Bad, And The Regulatory
    3/18/2019

    The clinical trial informed consent process is in dire need of optimization. High patient attrition rates indicate that we’re not doing enough to ensure patients truly understand the nature of their participation in clinical trials. We can do better. This webinar explains how organizations are using eConsent to enhance patient engagement, discusses regulatory considerations around eConsent, and more.

  2. eCOA Translations And Cultural Adaptation: Best Practices And Efficiencies
    3/15/2019

    While translation and cultural adaptation are time-intensive and require domain expertise, there are emerging best practices that not only save time, but also eliminate unnecessary work and reduce risk of error and timeline delays. his webinar will discuss the process of translation and cultural adaptation to support eCOA implementation on a global scale.

  3. Demystifying IRT Terminology Webinar
    3/15/2019

    “Configurable” and “customizable” are two commonly-used descriptors for interactive response technology systems that support clinical trials. Interpretations of these terms can vary widely. This webinar discusses definitions and system functionality in the context of configurable and customizable and includes systems development life cycle (SDLC) methodologies, the impact on timelines and cost and common applications in interactive response technology system designs.

  4. Protecting The Integrity Of Your Temperature Data In A Digital World
    2/26/2019

    Watch Almac’s on-demand webinar to gain an understanding of data integrity regulations and key considerations when utilizing a computerized system to manage temperature data during clinical trials.  This webinar will demonstrate how a secure, validated system is key in ensuring effective collection and management of accurate temperature data from the entire clinical supply chain.  

  5. Ready for eSource? Preparing For The Future Of Clinical Research
    2/19/2019

    Enhancing your data entry and monitoring and, as a result, strengthen your competitive edge. With eSource poised to become the next standard in clinical trial technology, the time is now to prepare for a new era in our industry.

  6. How to Leverage Clinical IRT To Improve Clinical Trial Efficiency Webinar
    2/7/2019

    This webinar will focus on the many attributes that must be considered to improve your clinical trial efficiency and experience. Participants will learn how to use the information you have from the protocol and clinical trial knowledge, along with clinical IRT expertise to ensure that the simple or complex randomization scheme is properly designed and set up to ensure flawless execution.

  7. Right-To-Try Or Right-to-Ask? Understanding Right-To-Try And FDA’s Expanded Access
    1/29/2019

    Right-to-Try has been in the news a lot recently, but what does it actually mean for product sponsors? This webinar explores both Right-to-Try legislation and existing Expanded Access Programs, including understanding sponsor responsibilities under these programs and when products may be eligible for these programs, evaluating options such as treatment protocols, treatment INDs, and emergency use, and discussing development risks associated with participation in these programs.

  8. Development Advice For Gene Therapy Products
    1/29/2019

    This webinar will review Commissioner Gottlieb’s statement, provide an overview of the six guidance documents, and discuss the implications for development of new gene therapy products from the perspective of regulatory strategy, clinical development, pharmacology/toxicology considerations, and CMC development

  9. How Linear Clinical Research Accelerated Trials Timelines And Improved Global Collaboration With eSource
    1/29/2019

    Explore the ways Medrio eSource has enabled Phase 1 clinical research unit improve global collaboration and accelerate trial timelines.

  10. Understanding Common Causes Of Failure in Depression Studies
    1/28/2019

    Dr. Jack Modell discusses why there is more to the story than placebo response in regards to the high failure rate of clinical studies in depression. Identify other factors that can contribute to failures and what steps can be taken to avoid those pitfalls.