Webinar: Innovative technology solutions for implementation of ICH E6(R2)

Sponsored by: Covance

Focused on:

  • Clinical Trial Data

Date: 25 October

Days to go: 33

Time: 4PM London/11AM New York

Sponsors running clinical research studies face enormous pressures today. From complex study designs, industry cost constraints, new geographical locations and significant technological advancements, there are many challenges to address. The International Council for Harmonization (ICH) efficacy guideline on Good Clinical Practice (GCP) aims to help sponsors keep up with these major shifts and implement improved practices in the industry.

In this webinar, we'll discuss how the ICH has changed with the recently approved revision E6(R2) and outlines some of the major areas where sponsors can develop more efficient approaches in the design and conduct of their clinical trials.

Learn how to better utilize your data to mitigate risk while also complying with the new ICH GCP E6 Revision 2 guidelines. Enable your entire study team to create, view and manage issues that emerge during the execution of a trial in real time.

Learn best practices on utilizing a comprehensive, technology RBM platform and central monitoring to:

• Streamline your clinical trial data into one centralized solution, easily viewed across all areas of the clinical trial
• Create, view and manage issues from one central location and holistically manage issues before problems arise.
• Increase operational efficiency and compliance, reduce risk and add an unprecedented level of transparency
• Reduce cost and complexity, and maintain high quality standards.

With the integrated Covance Xcellerate Informatics Suite, you will have the kind of insights into your trial that can help you minimize risk and gain better efficiencies.

Presented by

Adam Baumgart,

Senior Director, Xcellerate® Monitoring Solutions Development

Adam has spent 28 years in clinical research and has been with Covance for over nine years. With job roles in pharma, an EDC vendor and several major CROs, he is experienced in risk-based monitoring, central monitoring, process excellence, project management, clinical data management and clinical monitoring.

Adam’s role is senior director, Xcellerate Monitoring Solutions Development in the Covance risk-based monitoring (RBM) and central monitoring department. He leads the cross-functional transformational project team responsible for the implementation of RBM and central monitoring tools, processes, roles and services. Adam is passionate about the opportunity RBM brings to the way we work, our roles and the improvements in data integrity, patient safety and regulatory compliance.

Key Learning Objectives

  • Understand how ICH GCP E6 revision 2 impact running of trials
  • Consider complex ecosystem of managing risks, issues, actions, decisions and protocol deviations
  • Increase operational efficiency and compliance, reduce risk and add an unprecedented level of transparency

Audience

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