ICH E6 (R2): Best Practice Implementation and Technology Solutions for Pending Updates to Global GCP Guidelines

Clinical Trials, Life Sciences, Pharmaceutical, Pharmaceutical Regulation ,
  • December 01, 2016

With the impending finalization of the ICH E6 R2 Addendum, sponsors are taking the necessary actions to incorporate best-in-class tools and processes to meet the enhanced guidelines around data transparency and risk-based methodologies. Comprehend has partnered with Chaucer Life Sciences to blend its technology solutions for CRO oversight and Risk Based monitoring initiatives, with Chaucer’s expertise within clinical operations, GCP quality and vendor management.

During this webinar, Comprehend and Chaucer will discuss how to prepare your organization for excellence related to the increased requirements in vendor management, operational data collection and reporting, and risk-based monitoring. We will also provide a demonstration of the following:

  • Comprehend’s Best Practice KPIs, analytics and collaboration across systems, studies and CRO’s
  • Chaucer’s Vendor Engagement and Oversight (VEO) framework
  • Chaucer’s Risk Management tools
Keywords:

Speakers

Julie Peacock, Clinical Intelligence Expert, Comprehend

Closely aligned with customers and the sales organization, Julie focuses on enabling prospects and customers on Comprehend’s Clinical Intelligence solutions. She manages go to market strategy, sales enablement, and product marketing.

Prior to Comprehend, Julie spent 18 years at Oracle Corporation in the enterprise application space where she managed strategy, field enablement and launch activities for a series of BtoB solutions. Julie holds a bachelor’s degree in Marketing from Auburn University.

Chris Panteli, Principal and Managing Consultant, Chaucer Life Sciences

Chris Panteli has led multiple programs to strengthen vendor management and risk based approaches within Pharmaceutical sponsor organizations. Chris also benefits from consulting in other industries such as Oil & Gas as well as working within industry in Pharmaceuticals and brings years of experience in running large programs and integrating technology and advancement in delivering innovative approaches. In addition to providing solutions for Chaucer’s clients, Chris is a key member of Chaucer’s solution development team across brands.

Who Should Attend?

Clinical Operations and Data Management Professionals

  • Clinical Trial/Clinical Study Management
  • Clinical Data/Informatics/IT
  • Clinical Outsourcing
  • Protein/Antibody Engineering

Clinical Research, Technology and Business Professionals

  • Biometrics/Biostatistics
  • Business Technology/Applications/Solutions
  • Business Analyst
  • CTO
  • Project Management

Xtalks Partners

Comprehend

Comprehend offers a suite of Clinical Intelligence applications that enables ClinOps Execs, Data Managers and Medical Monitors to significantly improve the speed, safety and quality of a portfolio of clinical trials. Across studies, sites, systems and CROs, Comprehend’s Clinical Intelligence Suite is particularly effective for centralized monitoring, risk monitoring, CRO oversight and collaboration, and medical monitoring initiatives. Comprehend gives life sciences companies a new source of competitiveness and the confidence to deliver high quality trial submissions at a new speed. Comprehend: the speed to quality results. Learn more at www.comprehend.com

Chaucer Life Sciences

Chaucer Life Sciences has been supporting the life sciences sector as specialists for 30 years.

In this continuously changing industry, we understand the challenges that our clients face first-hand, as well as the opportunities for driving high impact change. We employ experienced consultants working from hubs in Europe and the US who work side-by-side with our clients to deliver results-driven programs across the drug continuum and corporate functions.

Media Partners

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