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October 4, 2012
Innovative Solutions Designed to Improve Operational Capacity, Efficiency, and Effectiveness in Clinical Monitoring
  • Brett Barber, Senior Director, Strategic Sourcing, PharmaNet/i3   Learn More
  • Nicole Baker, Director, Strategic Resourcing, PharmaNet/i3   Learn More
  • Lisa Rhiner, Clinical Study Lead, PharmaNet/i3   Learn More
  • Innovative Solutions Designed to Improve Operational Capacity, Efficiency, and Effectiveness in Clinical Monitoring

    Today, sponsors place great value on methods for reducing cycle times and providing greater efficiency in monitoring. Likewise, greater regulatory emphasis on product safety and efficacy has led to a greater need to establish standardized and centralized processes that incorporate expedited data review.

    Standard centralized processes enhance consistency, quality, and speed and optimize resource utilization during study start-up activities, clinical monitoring visits and data review. This webinar provides a valuable methodology to build efficiencies in these critical components of study conduct to:

    1. Address economic and quality issues with study start up
    2. Design the most efficient standardized workflow for our CRAs
    3. Establish a dedicated, centralized data review process to drive efficiency and quality

    Each of these innovative solutions is designed to optimize resource utilization, better manage demand and capacity, and ultimately provide high quality study deliverables within time and cost constraints.

    Learning Objectives

    1. Apply innovative approaches to resourcing, study start up, and data review through standardized and centralized practices
    2. Describe how a standardized monitoring process can reduce cycle times and impact monitoring efficiency
    3. Evaluate the use of metrics to ensure project delivery, patient safety and bolster organizational performance

    Senior level executives involved with Clinical Operations, particularly those interested in:

    • Dedicated study start-up process
    • Efficient, effective and high-quality study monitoring practices
    • Eyes on data-risk-based monitoring

    Brett Barber, Senior Director, Strategic Sourcing, PharmaNet/i3

    As the Senior Director within Strategic Resourcing, Brett is responsible for Global Clinical Services including Monitoring and Study Management for one of the largest sponsors at Pharmanet/i3.

    Brett began his 20 year plus pharmaceutical career as a CRA and soon moved to Novartis as the Manager of Contract Administration and later as Northwest Regional Manager. He joined Pfizer Inc. in 1999 as the Southwest Regional Head, assumed responsibilities as Director of Clinical Operations in 2006 and Head of Clinical Operations in 2008. He was recently Senior Director within Business Development at Pharmanet/i3.

    Brett earned a Bachelor’s of Science in Kinesiology from the University of California, and a Master’s of Science in Cardiovascular Physiology from the University of Toronto.


    Nicole Baker, Director, Strategic Resourcing, PharmaNet/i3

    Nicole has 20 years of experience in the clinical research industry, working across all phases of clinical trials in multiple therapeutic areas including Oncology, Rheumatology, CNS, Cardiovascular, Dermatology and Hypercholesterolemia. In her current role, Nicole ensures quality, performance, and compliance within her assigned Sponsor engagements. Additionally, she develops and coordinates quality and compliance metrics and reporting to stakeholders. Nicole has also participated in the development of dedicated study start up teams and centralized data review teams during her nearly eight-year tenure with Kforce Clinical Research.

    Prior to joining Pharmanet/i3, Nicole served as a Regional Site Manager with Pfizer, a Regional CRA with Quintiles and a Regulatory Affair and Quality Assurance professional for several pharmaceutical companies where she developed and implemented a clinical trial audit policy, as well as performed in-house and site audits of clinical trial activities. She earned a bachelor’s degree in Microbiology from the University of Alabama.


    Lisa Rhiner, Clinical Study Lead, PharmaNet/i3

    As the Clinical Study Lead on a rare disease project, Lisa is responsible for clinical support and guidance, process improvement and clinical aspects of data management for the study.

    Accomplished in drug and device monitoring, project management, study start-up and clinical operations Lisa has over 20 years experience in the Pharmaceutical Industry working across complex therapeutic areas, such as oncology and rare diseases. Her focus in operations centered around centralized and SWAT resourcing, business process development and improvement and oncology TA training. Prior to joining PharmaNet/i3 in 2005 she monitored device trials for Boston Scientific and prior to that Lisa managed the sponsor trials for a not for profit Clinical Community Oncology Program, through the NCI.

    Lisa recently presented; ‘Optimizing the Monitoring Visit with Standardized Practices’ at the 2012 DIA Meeting with Ken Getz.


    inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 70 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bioanalytical services, and strategic resourcing.

    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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