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November 11, 2013

Successful Pediatric Studies: Key Study Design and Operational Considerations

Speaker for this Event:
  • Alison Sampson, Senior Project Director, Premier Research
  • The frequent reminder in pediatric research is that ‘children are not simply miniature adults’, and as such special considerations and methods are necessary in the implementation of clinical trials in youth.

    This webinar will discuss factors critical to success in the design and execution of pediatric clinical trials. The presenter will review criteria for studies that are both scientifically rigorous while meeting the high ethical standards required of clinical trials in the vulnerable pediatric population.

    Additionally, approaches to site selection, enrollment and retention will be discussed as consideration beyond the patient are necessary when the reality is that whole families may be impacted by clinical trials. 

    THIS PROGRAM IS INTENDED FOR

    VPs, Directors, Managers, Department Heads, Scientists and Researchers working within:

    • Clinical Affairs
    • Clinical R&D
    • Clinical Research
    • Clinical Pharmacology
    • Clinical Operations
    • Project Management
    • Regulatory Affairs
    • Medical Affairs

    for pharmaceutical, biotechnology and medical device companies

    ABOUT OUR SPEAKER

    Alison Sampson, Senior Project Director, Premier Research

    Alison Sampson has over 20 years Clinical Research Experience including roles as CRA, Project Manager, Senior Project Manager and Project Director covering phase I – IV global studies. As an experienced Project Manager, she has led both clinical and cross-functional teams.

    She has worked in all phases of clinical research (I-IV) including global phase III studies as the Global Project Manager. She has experience of a wide variety of therapeutic areas with particular expertise in oncology, medical devices and rare diseases in pediatrics and neonates. Her work experience includes roles in Biotechs, Blue Chip Pharma and CROs.

    Prior to entering clinical research, Dr. Sampson trained as a chemist and she is a Chartered Member of the Royal Society of Chemistry. She achieved Chartered Scientist Status in February 2009 through the Institute of Clinical Research.

    OUR XTALKS PARTNER FOR THIS EVENT

    Premier Research is a leading global contract research organization serving biotech, pharmaceutical and medical technology companies.The company has a wealth of experience in rare disease and pediatric research having managed about 100 projects in each area in the last five years alone. Its services include clinical research and regulatory outsourcing in the areas of analgesia; neurology; infectious, cardiovascular, and respiratory disease; dermatology; oncology; and medical devices.

    Premier Research has 21 offices (seven in North America, 14 in Europe) and operates in 23 countries. It employs 1,200 clinical professionals dedicated first and foremost to fulfilling each customer's requirements in a timely, accurate, and cost-effective manner. This includes a strong international network of monitors and project management professionals combined with regulatory, data management, statistical, scientific, and medical experts, and staff at its well-established network of dedicated clinical sites.

    For information about the recorded archive for this event contact Xtalks at (416) 977-6555 ext 371, or email register@xtalks.com

     
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