Actionable & Adaptive RBM: PerkinElmer’s Comprehensive Approach to Risk-Based Monitoring

Clinical Trials, Life Sciences, Pharmaceutical, Pharmaceutical Regulation ,
  • October 26, 2016

If your organization is interested in adopting Risk-Based Monitoring, you understand that 100% SDV and schedule-driven monitoring is not an effective or cost-efficient approach to trial monitoring. Instead, you are looking for a solution that will help your central monitors, remote monitors, and CRAs quickly and easily evaluate risk across the study and target monitoring activities where they can be most impactful. With the PerkinElmer RBM, you can easily navigate from high-level overview data to specific data points from multiple source systems at once.

Join this webinar to see the PerkinElmer RBM Solution in Action. Learn to:

  • Easily navigate from overall and category-level views to individual KRIs
  • Quickly access actionable insights from multiple source systems
  • Model recommended actions and follow up on those actions, all in one place
  • Learn as you go – evaluate the efficiency of your risk model and adjust recommended actions, weightings, and thresholds
  • Unlock the value of historical data – get ready for ICH E6(R2) by establishing meaningful tolerance limits for risk indicators
  • Adapt a proactive approach to risk management, merging RBM and QBD

Data visualization and analytics is only the beginning of a holistic RBM program. Register to see how PerkinElmer put the principles of actionable and adaptive RBM to work in an enhanced RBM offering. The solution offers a guided workflow specific to the user’s role and a closed-loop approach to RBM: trigger recommended actions in response to risk and follow up on those actions, all in one place. How do you know if these actions are impactful? You’ll see how the solution allows the central monitor to evaluate the risk model as a whole, easily adjusting weightings, thresholds, and recommended actions accordingly.

Keywords:

Speakers

George H. Johnson IV, SCPM, Senior Consultant Clinical, Services Lead for Risk Based Monitoring and Data Provisioning, PerkinElmer Informatics

George Johnson is currently a Senior Consultant Clinical, Services Lead for Risk Based Monitoring and Data Provisioning at PerkinElmer Informatics. George has over 13 years of experience as a Business Analyst and Business Systems Analyst and prior to joining PerkinElmer, he held consulting and business analysis roles at several companies including PAREXEL where he worked with clients to define and implement clinical and regulatory metrics used for trial reporting. George earned his Bachelors from Quinnipiac University and holds a professional certificate from Stanford University in Project Management.

Who Should Attend?

Executives and clinical operation management in biopharmaceutical, medical device and diagnostics manufactures, including:

  • Program, Country, Study Managers
  • CRAs or Clinical Monitors
  • Clinical Research Management Teams
  • Clinical Trial Managers
  • Sr. Manager/Director/VP R&D Clinical Informatics
  • Data Managers clinical
  • CROs – any level

Xtalks Partners

PerkinElmer

PerkinElmer’s advanced analytics and services solutions for Clinical Development help the world’s leading bioPharmaceutical, medical device and diagnostics manufactures discover new therapeutics faster by streamlining clinical operations, transforming risk into safety and enabling actionable decisions that can lead to better health outcomes.

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