Webinar: Proactively Manage Your Clinical Trial Risks

Sponsored by: Covance

Focused on:

  • Risk
  • Ich Gcp Guidelines

Date: 5 October

45

Time: 4PM London/11AM New York

Why wait for risk? Be proactive. Develop a plan to identify risk early in your study. Use of a comprehensive risk-based monitoring plan is not an option anymore, it’s a necessity. With the new ICH-GCP guidelines in place, you need to have a solid RBM plan in place.

Covance has developed Xcellerate® Monitoring, a solution that contains multiple products designed to help the entire study team define and manage risk before they emerge during the execution of a trial. With a unified view, you will have the kind of insights into your trial that can help you identify risk and gain better efficiencies.

Join us for an informational webinar and learn how two of our monitoring products, Xcellerate Risk Review and Xcellerate Risk Assessment Categorization Tool (RACT) combine to help you:

• Assess, categorize and identify critical data
• Identify issues and develop a tailored risk assessment
• Create a comprehensive risk mitigation plan

Don’t miss out! Register today!

Presented by

Olivia Feiro, PMP,

Senior Manager, Monitoring and Data Flow Optimization

Olivia Feiro has over 12 years of experience in various research and trial management capacities. She currently serves as a senior manager in monitoring and data flow optimization at Covance where she is responsible for providing clients with Covance’s Xcellerate Monitoring methodology and technology implementation. Her areas of focus include Xcellerate Risk Review and Xcellerate Medical Review.

Olivia began her career as a clinical research assistant and held industry positions as clinical research associate and project manager. Olivia graduated from Temple University in Philadelphia, Pennsylvania with a M.A. in neuroscience and from Indiana University in Bloomington, Indiana with a B.A. in both art history and psychology, and has Project Management Professional (PMP) certification.

Gayle Keenan,

Senior Manager, Monitoring and Data Flow Optimization

Gayle Keenan has over 22 years of experience in clinical trials. She currently serves as a senior manager in monitoring and data flow optimization (MDFO) at Covance where she is responsible for developing business processes and technology solutions. Her areas of focus include Risk Assessment and Categorization and Xcellerate Risk Review.

Gayle began her career in the industry as a clinical studies assistant at Covance, moving onto clinical research associate and project management prior to joining the MDFO. Gayle graduated from University of Leeds, UK with a BSc(hons) in biochemistry and microbiology, and then completed a MPhil (immunology) at the Clinical Research Centre, Northwick Park Hospital, UK. Gayle is also a certified Project Management Professional (PMP).

Key Learning Objectives

  • Learn how to holistically manage risk in your clinical trial
  • Proactively implement a cross functional risk assessment in study planning
  • Develop an adaptive intervention plan based on site risk
  • Prepare a monitoring plan for the new ICH-GCP E6 R2 guidelines

Audience

  • Director
  • VP
  • C Level
  • Head of
  • Clinical Operations
  • Central Monitoring
  • Risk Based Monitoring
  • Data Management
  • Regulatory Compliance
  • Informatics
  • Procurement