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Tuesday, June 26 • 4:15pm - 5:30pm
#287: The Letter and Spirit of Risk-Based Monitoring: How to Creatively Implement Risk-Based Modeling and Unlock the Potential of the Team

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-615-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will focus on real-life experiences with risk-based monitoring (RBM) implementation and share lessons learned on how RBM principles were adapted to the realities of the company structure and innovative approaches that go beyond large-pharma RBM models. Presenters will review their journey to obtain meaningful analytics, key risk indicators and thresholds,mitigation actions,workflow management, and how the new process impacts the actual risk identification and management. The session will explore how the RBM process works in the outsourcing model, and how it impacts CRO oversight and provide updates from TransCelerate, including lessons learned from RBM implementations, best practices for adoption, and post-adoption metrics and observations.

Learning Objectives

Discuss options for creative implementation of risk-based monitoring processes; Examine the correlation between the risk-based monitoring KRIs and existing metrics; Discuss the impact on roles and opportunities for clinical data management with the adoption of risk-based monitoring.

Chair

Teresa Ancukiewicz, MA

Speaker

Creative Implementation of Risk-Based Monitoring by Unlocking the Potential of Study Team
Teresa Ancukiewicz, MA

Risk-Based Study Management: From Risk Identification to the Study Closure for In-House and Outsourced Studies
Johann Proeve, PhD

Best Practices and Observations from Implementing TransCelerate’s Risk-Based Monitoring Model Framework
Suzanne Lukac


Speakers
avatar for Teresa Ancukiewicz

Teresa Ancukiewicz

Senior Manager, Clinical Data Management, Boston Scientific Corporation
Senior Manager in Clinical Operations at Boston Scientific for the last 14 years, CCDM. Responsible for providing leadership in outsourcing initiatives and Risk Based Monitoring. Over 20 years of experience in clinical data management, process development and improvement, and vendor... Read More →
avatar for Suzanne Lukac

Suzanne Lukac

Director, Global Monitoring Excellence, Risk-Based Monitoring Implementation, Merck & Co., Inc.
Suzanne has more than 15 years experience in the pharmaceutical industry. She is the current Project Director for Merck’s Risk-Based Monitoring Implementation Initiative, overseeing all Work Stream activities and process creation using TransCelerate methodology. She has held prior... Read More →
avatar for Johann Proeve

Johann Proeve

Chief Scientific Officer, Cyntegrity
He studied agro-biology and started his business life in 1980 at Bayer in Clinical Data Management. Between 1990 and 1994 he had been Head of Clinical Data Management at Bayer Corp in West Haven, Connecticut, USA. Since 2000 he had been the Head Global Data Management at Bayer Healthcare... Read More →

Tuesday June 26, 2018 4:15pm - 5:30pm EDT
Room 205C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  08: R and D Quality-Compliance, Session