Using a Clinical Quality Risk Management (QRM) Process to Implement Risk-Based Monitoring: Concepts and Case Study

Life Sciences, Clinical Trials, Pharmaceutical,
  • Wednesday, October 01, 2014

Implementation of centralized monitoring is significantly more than simply shifting certain clinical monitoring activities that were once conducted on site. In today’s monitoring environment which has been enabled by recent guidance and reflection papers by regulators on clinical risk-based approaches to monitoring clinical study quality, monitoring activities should now be designed to track two types of risks identified in the clinical risk assessment:

  • Fixed risks, which are controlled by specifications in functional plans such as the clinical monitoring plan and data management plan; and
  • Dynamic risks, which are controlled by tracking key risk indicators (KRIs) which are defined in the systematic clinical risk assessment to trigger corrective actions if the KRI values exceed predetermined thresholds.

Implementing all of this with the appropriate processes, enabling technologies, and workflow management is the topic of a case study concluding the presentation.


Michael Macri, Director, Strategic Services, inVentiv Health Clinical

Michael Macri has been in the BioPharmaceutical industry for over 25 years working in Clinical Operations. His expertise includes design, implementation and execution of clinical trials. He began his career at a large Pharmaceutical company in Data Management and then moved to a Clinical Operations. He spent 14 years at a leading Biotechnology company and held a number of positions, including CRA, Study Manager, Project Manager, Regional Manager, and Director of Clinical Field Operation. Michael Joined the CRO industry in 2008 where he was an Area Director responsible for leading site management activities across the Western United States for a large Pharmaceutical company, including oversight of site management activities for oncology studies. Michael has significant experience in strategic planning, problem solving, communication, teamwork, and line management. In addition, he has experience with all phases of Clinical trials, CRO selection and oversight, and organizational change management. Michael has a BS in Medical Technology from Quinnipiac College, an MBA from Sacred Heart University, and he is a certified Project Management Professional. In his current role as Director, Strategic Services, Michael is responsible for leading a global initiative in Risk-Based Monitoring at inVentiv Health clinical.

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Jeffrey Fetterman, President, ParagonRx, an inVentiv Health company

Jeffrey Fetterman is President of ParagonRx International, an inVentiv Health company that was founded on the principles of health systems engineering and a pioneer in Pharmaceutical risk management. As the center of excellence for Quality Risk Management (QRM) at inVentiv, the business conducts Systematic Risk Assessments that manage risks in the use of medications as well as the clinical study of medical products.

He is co-author and co-editor of two books: A Framework for Pharmaceutical Risk Management, that documents a process for the design and implementation of risk management programs for drugs with safety concerns, and Pharmaceutical Risk Management: Practical Applications, that offers pragmatic approaches to fulfill evolving regulatory requirements on the topic.

In previous work, he co-founded Empower Health, a business that integrated care management tools and services to improve clinical health outcomes of people with chronic illness. Fetterman has extensive Pharmaceutical industry experience, having led marketing, medical education, strategic planning, and business development organizations at DuPont Pharmaceuticals and DuPont Consumer Health.

His original work was in the field of nuclear engineering, in which he led the startup safety assessment of a nuclear reactor operated for the Department of Energy. He is an Adjunct Professor in the Lehigh University Healthcare Systems Engineering program that applies industrial systems improvement methods to the complex healthcare system. He is also a board member for First State Innovation which fosters entrepreneurial businesses in the Mid-Atlantic region. He holds a B.S. in Chemical Engineering from Lehigh University and an M.B.A. from Katz School of Business at University of Pittsburgh.

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Xtalks Partners

inVentiv Health Clinical

inVentiv Health Clinical is a next generation CRO. With 6,500 employees operating in more than 70 countries, we take a patient-centric approach and apply smarter, fresher thinking to go well beyond traditional outsourced services. We are a leading provider of global drug development services to the bioPharmaceutical industry, offering therapeutically specialized capabilities for phase I-IV clinical development, bioanalytical services, and strategic resourcing – from a single clinical professional to an entire functional team

inVentiv Health

As part of inVentiv Health, we are the only company in the world that can both develop and fully commercialize products for the life sciences industry. We’ve helped more than 550 bioPharmaceutical companies conduct clinical trials and have supported nearly two-thirds of all drugs approved by the FDA over the past five years.

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