Clinical Leader Webinar

  1. Platform Trials, Medical Supply And Cooperation For COVID-19 Vaccines 6/15/2020

    COVID-19 has brought a number of stakeholders together to seek ingenious new methods for vaccines development. Here James Orbinski, who received the Nobel Prize as the head of Medecins Sans Frontieres joins Trevor Mundel, President of the Bill and Melinda Gates Foundation, Robin Mogg of the Bill & Melinda Gates Research Institute, and Derek Angus of REMAP-CAP, one of the largest platform trials in the search for a coronavirus vaccines, to discuss new opportunities for public-private and non-profit cooperation for vaccine development.

  2. Trial Disruptions Due To COVID-19? Adaptive Bayesian Approaches Reveal Promising Possibilities 6/15/2020

    A number of trials have been disrupted by the onslaught of the COVID-19 pandemic. A Cytel panel discussion reveals the strategic advantage of using Bayesian methods to resolve a number of trial challenges ranging from small sample sizes, flexible designs, missing data, and unpredictable recruitment. Here leading biostatisticians and former regulators discuss the opportunities these adaptive Bayesian methods offer.

  3. Remote Consent: Adjusting To The New Normal In Clinical Trials 6/3/2020

    The global pandemic has brought the need to enrol new patients quickly in COVID19-related trials and keep patient engagement high in ongoing trials, even as face-to-face interactions are limited. This presentation will review sponsor and site frequently asked questions about electronic and remote consent capabilities as they seek to consent patients in new and faster ways.

  4. Remote Monitoring: Connecting Sites, Sponsors, And CROs To Drive Quality 6/1/2020

    How can sites share information and engage with monitors in a compliant way, while ensuring quality and efficiency in the future? Hear from Parexel, Mid Hudson Medical Research, and Veeva on how sites, sponsors, and CROs are improving clinical trials in the long term with remote monitoring.

  5. Three Necessary Steps When Designing Your New World Protocol 5/28/2020

    A huge upswing in data volume and number of technologies that can be leveraged to garner valuable patient insights for clinical trials is forcing the industry to rethink protocol design. Join us for a step by step look at how to implement new world clinical development approaches into your protocols and develop a strategy for capturing high quality efficacy and safety data, while also facilitating compliance and optimal use of technology.

  6. Using Artificial Intelligence To Improve Clinical Trial Efficiency And Optimization 5/28/2020

    Key to reducing these complexity of initiating studies is the ability to be able to leverage operational insights with granular performance metrics and machine learning, which can guide clinical research staff in their daily activities. Machine learning technologies can help predict outcomes in clinical trials, leading to faster drug approval times, lower costs, and more funding to develop new treatments. How can machine learning deliver business intelligence before starting studies?

  7. Sources, Effects, And The Importance Of Elemental Impurities For Finished Drug Products 5/19/2020

    Elemental impurities can arise from a variety of sources, such as active pharmaceutical ingredients (API), excipients, manufacturing equipment, and primary container closure systems.  ICH Q3D recommends that manufacturers conduct a product risk assessment by identifying and assessing known and potential sources of elemental impurities.  This webinar reviews the impact of the most recent regulatory changes related to elemental impurities testing, guidance on the best routes to compliance, and an overview of the elemental impurities risk assessment process.

  8. How Sponsors Turn Disclosure As A Service Into A Strategic Advantage 5/18/2020

    In this panel discussion, Teva and Lung Biotechnology disclosure experts discuss why they opted for disclosure as a service. They will detail how it helps them safeguard regulatory compliance and mitigate risk.

  9. New Opportunities & Implications For The Future Of Drug Development In Emerging Economies 5/11/2020

    Ed Mills, Cytel’s Vice President of Real World Evidence hosts a panel on how COVID-19 is affecting access to drug development and equitable medical care in emerging economies.

  10. Experts From China Speak On Conducting Clinical Trials During Covid-19: Part 2 5/1/2020

    A follow-up to our first DIA DIRECT COVID-19 webinar, join us to hear experts from China answer your questions about conducting clinical trials during the pandemic. Representatives from across various healthcare product development functions will discuss steps currently in place to ensure safety and efficacy of clinical trials continuing through COVID-19.