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July 23, 2013

DOs and DON’Ts of Study Start-Up: Best Practices to Improve Efficiency and Meet/Exceed

Speakers for this Event:
  • Michelle Archibald, Senior Director, Site & Patient Strategies, Quintiles   Learn More
  • Nicole Turner, Associate Director, Global Feasibility, Quintiles   Learn More
  • Julie Parmelee, Director, Patient Recruitment, Quintiles   Learn More
  • Mark Brown, Vice President of Strategic Site Intelligence and Feasibility, Quintiles   Learn More
  • Efficient and effective study start-up is crucial to the success of your study. In particular, the following challenges have a significant impact on study start and timely delivery.

    • Country and site selection
    • Investigator predictability for patient recruitment
    • Resource oversight and team collaboration

    In order to address these challenges and set the path for success, several questions should be considered:

    • How do you select countries and sites that will improve your chances of finding and retaining the right patients for your study?
    • Can you cost-effectively implement a proactive patient strategy, and avoid the need for rescue programs?
    • How can you leverage data and planning techniques to minimize management oversight while optimizing efficiencies by matching studies, sites, and patients impacting patient health?

    In this webinar we will discuss best practices for applying quantitative and qualitative information to develop study strategies, from feasibility through patient recruitment. We will highlight how an empowered delivery team can enhance efficiency, minimize the need for extensive oversight, and deliver greater overall accountability for meeting your study goals.

    Through case examples, we will show how the appropriate tools and insight from data and strategies are applied in a real-world setting to deliver tangible benefits to clinical development stakeholders.

    By attending this webinar you will learn how planning can help avoid costly delays and quality issues, ultimately saving you time and money. Topics covered include:

    • Developing a plan to proactively address patient recruitment and retention risks, with a trigger-based phased approach that will help you meet your patient goals
    • Objectively selecting countries, sites, and investigators for your study to optimize patient recruitment potential
    • Encouraging efficiency and empowering teams at all levels, from site to CRO/Sponsor
    THIS PROGRAM IS INTENDED FOR

    Executives and managers involved with Clinical Operations:

    • Project Managers
    • Clinical Operations
    • Outsourcing/Procurement
    • Trial Planning
    • Country Selection and Site identification
    • Regulatory
    • Product or program managers
    ABOUT OUR SPEAKERS

    Michelle Archibald, Senior Director, Site & Patient Strategies, Quintiles

    Michelle Archibald has an extensive and broad background in global drug development. She has worked in the CRO and Biotech industry for nearly 20 years in multiple management and leadership roles. As Senior Director of Site & Patient Strategies she is responsible for developing strategies for clinical trials and alliances with key customers, enhancing global collaboration and strategic planning for oncology activities between Integrated Site Services and Therapeutic Delivery Units.

    As a Senior Director and previously as Director Ms. Archibald had responsibilities for line management, executive oversight of multiple clients and projects, proposal review, resource management, training, and other related managerial activities. In past roles she has been a Therapeutic Strategy Lead in Oncology, Director of Project Management, and Director of Clinical Operations. Her responsibilities included line management of approximately 35 direct reports, resource management for Clinical Development North America, mentoring and CRA resource management for Poland and Canada, and project management responsibility for multiple Oncology and CNS projects. In addition, she has performed in the roles of Research Assistant, CRA, LCRA, and Sr. Manager. She has managed and monitored domestic and global trials within the biopharmaceutical industry including Phase I through Phase IV in a variety of therapeutic areas.

    Ms. Archibald holds a MBA in management from RIT and a Certificate in the Business in Medicine from Johns Hopkins. She has 15 years operational experience working in Oncology therapeutics with over 7 years working in strategic planning.

    Nicole Turner, Associate Director, Global Feasibility, Quintiles


    Nicole Turner manages the North America Global Feasibility team at Quintiles. Her team is responsible for providing robust, comprehensive feasibility assessments that enable more effective planning at various stages of the clinical development continuum. Nicole works to combine and analyze relevant data from various primary and secondary sources to guide protocol development, evaluate potential study risks, and develop the most appropriate country and site strategies for clinical trials; this work spans all therapeutic areas and most indications, with more than 1500 feasibility assessments conducted over the past 5 years.

    Ms. Turner holds a Bachelor of Science degree in Animal Science from North Carolina State University and a Masters of Business Administration from Elon University. Nicole has 10 years of experience in clinical research, including 3 pre-clinical research and development and 7 years in the CRO setting.

    Julie Parmelee, Director, Patient Recruitment, Quintiles

    Julie Parmelee is a senior leader of the Patient Recruitment services team at Quintiles. She is responsible for developing patient strategies for clinical development programs across a wide range of indications, as well as driving innovative solutions to address recruitment and retention challenges. Patient strategy is a critical part of the clinical trial planning process at Quintiles. To craft an effective global recruitment strategy, she combines data-driven insights from patients, investigators, and in-country regulatory specialists together with the operational and therapeutic expertise across Quintiles.

    Created as a dedicated group within Quintiles in 1996, Patient Recruitment services is an integrated internal operations team, jointly accountable for recruitment goals with Clinical Project Management. The team has supported 270 studies across 100 indications since 2009 and draws upon a robust infrastructure of in-house resources to recruit the right patients in the simplest and most cost-effective way possible. In 2012, studies supported by the team enrolled at an average of 112% of monthly enrollment targets.

    Ms. Parmalee holds a Bachelor of Science degree in Advertising from Ferris State University and has more than 20 years of experience in healthcare marketing including clinical research, diagnostics, pharmacogenetics, and patient communications.

    Mark Brown, Vice President of Strategic Site Intelligence and Feasibility, Quintiles

    Mark Brown has over 20 years experience in clinical research in a multiple roles ranging from IT, Systems Validation, Data Management and most recently Investigator Site Management. Drawing on this broad experience, he currently manages the Integrated Patient and Site Strategies team at Quintiles. His team is focused on developing operational strategies for customer development programs. The scope of the team includes Protocol Feasibility, Strategic Site Intelligence, Patient Outreach, and Global Site Identification.

    OUR XTALKS PARTNER FOR THIS EVENT

    Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, and consulting solutions worldwide. The Quintiles network of more than 27,000 engaged professionals in 59 countries works with an unwavering commitment to patients, safety and ethics. Quintiles helps biopharmaceutical companies navigate risk and seize opportunities in an environment where change is constant. For more information, please visit http://www.quintiles.com/.

    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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