Collaborative Risk Management: Plan & Pivot Your Clinical Studies

Clinical Trials, Drug Safety, Life Sciences, Pharmaceutical, Pharmaceutical Regulation,
  • Thursday, January 17, 2019

Sponsors and CROs are under increasing pressure to monitor and manage risk from various perspectives and under multiple FDA guidances. Complying with regulations such as ICH E6(R2), while meeting milestones and addressing issues, is time-consuming and costly.

This webinar will dive into best practices for the identification and ongoing management of risk during the clinical trial process. Featured speakers will also present a case study of a leading pharmaceutical company that faced multiple challenges affecting its risk profile.

Join this webinar for a discussion of best practices—including how to define, analyze, and operationalize the risk management process in the study conduct phase—that you can use to answer important questions, such as:

  • How can I identify and mitigate risk earlier?
  • How can we put lessons learned into our risk mitigation plans moving forward?
  • What metrics and/or processes can be used to help resolve risks that are identified?
  • How can team members from the CRO, sponsor, and other vendors collaborate more effectively to actively identify and manage risk?

Join Heather Davis, an industry veteran with more than 26 years of experience in clinical trials, and Comprehend for this informative webinar.

Speakers

Julie Peacock, Client Services, 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.

Message Presenter

Heather Davis, Independent Consultant, Maven Ridge

Heather brings more than 26 years of experience in clinical trials project management, clinical monitoring, and operational strategy across the biotech and CRO industries, with a specialty in oncology clinical trials.

She holds a bachelor’s degree in Environmental Studies: International & Environmental Development from the University of Colorado at Boulder.

Message Presenter

Who Should Attend?

CROs, Clinical Operations, and Data Management Professionals

  • Clinical Trial/Clinical Study Management
  • Clinical Data/Informatics/IT
  • Clinical Outsourcing
  • Clinical Project Managers
  • Clinical Project Directors
  • Director of Project Delivery

Clinical Research, Technology, and Business Professionals

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

What You Will Learn

Join this webinar for answers to your most pressing risk management questions, including:

  • How can I identify and mitigate risk earlier?
  • How can we put lessons learned into our risk mitigation plans moving forward?
  • What metrics and/or processes can be used to help resolve risks that are identified?
  • How can team members from the CRO, sponsor, and other vendors collaborate more effectively to actively identify and manage risk?

Xtalks Partner

Comprehend

Comprehend provides a suite of cloud applications and consulting services that dramatically improve the clinical trial process. Our solutions deliver actionable risk and performance insights across studies, systems, sites, and vendors. By using elements of our Clinical Intelligence Platform to unify, monitor, and analyze data across all sources, sponsors and CROs alike are able to reduce risk, achieve milestones on time, and stay within budget. As a trusted partner, Comprehend helps speed the time to quality results.

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