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Operational Excellence in Immuno-Oncology Clinical Trials


Date: January 26, 2017 60 minutes)

Featured Speakers:

    As cancer treatments become more focused on personalized care for the patient, understanding the intricacies of immuno-oncology becomes increasingly important. Join our speakers who will outline how to manage the complexity of these studies and ways to maintain a successful partnership with your CRO.

    In this webinar, the speakers will:

    • Examine the complexity of CAR-T studies including:

      The general therapeutic process from patient identification to post-infusion
      o Startup considerations
      o Biovigilance

    • Explore logistics management in a successful CAR-T study including:

      o Identifying key departments and staff for the study
      o Defining the role of the logistical coordinator
      o Other best practices

    • Review the process for a successful partnership between CRO and investigative site including:

      o Mitigating risk through proper planning
      o Training site staff
      o Meeting monitoring requirements

    Keywords: Clinical Trials, Oncology, Immuno-Oncology


    Megan Liles, Director, Project Management, Chiltern

    Megan Liles has over 19 years' clinical research experience including project management, monitoring and study coordination across multiple therapeutic areas including oncology, infectious disease (adult and pediatric), respiratory (adult and pediatric), and pain. Liles has extensive experience in developing, managing and monitoring all aspects of complex, adaptive design, cohort-driven Phase 1 and 2 studies from start-up through submission of the Clinical Study Report.

    Lynn Donald, Project Director, Chiltern

    Lynn Donald has over 15 years’ experience in the CRO industry from pre-clinical to managing full service global clinical studies. Donald is now project director with Chiltern early phase oncology currently managing and overseeing the start-up of CAR-T study with sites in the United States and Europe. Donald’s interests and expertise lie in oncology and has worked with both small biotechs and large Pharma on some exciting new treatments.


    Senior level professionals focused on oncology and immune-oncology, including:

    • Directors of Outsourcing / Procurement / Project Management / Study Management / Clinical Operations
    • Investigators and Study Coordinators


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    Chiltern, a global contract research organization, is a leading provider of clinical solutions in a variety of specialty areas and engagement models for biopharmaceutical and medical device industries. Chiltern’s team of more than 4,200, located across 47 countries, provides comprehensive Clinical Development, Medical & Scientific Affairs, Data & Analysis, Pharmacovigilance, Strategic Regulatory and Clinical Supplies services using a collaborative approach to maximize efficiency and minimize delays. Visit Chiltern.com to learn more about how Chiltern is Designed Around You®.

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