There is broad recognition of the need to transform drug development to reduce the time, cost and risk involved in innovation. Sponsors and CROs know that a new paradigm of clinical trial monitoring is critical to their success, and to the future of clinical research. Risk Based Monitoring (RBM) is an accepted method covered by FDA draft guidance and an EMA reflection paper. This approach involves adjusting the monitoring strategy based on level of risk, reflecting the reality that 20% of clinical trial sites contribute to 80% of quality issues.
The speakers will provide a definition of RBM, insight into the regulatory landscape, and a perspective on executing RBM leveraging three elements:
- People: The FDA guidance notes the trend for centralized monitoring. This presents opportunities for CRAs and Data Managers, as well as the evolution of a new internal CRA role (iCRA) for in-house monitoring and data-quality support.
- Process: This involves the use of risk indicators to drive monitoring; for example, data indicating an atypical level of protocol deviations will trigger a site visit.
- Technology: Regulators envisage that centralized monitoring will use technology to ensure consistency, identify high-risk sites and trigger alerts. Technology allows the pooling of data, so that sponsors and CROs can initiate the right action at the right time for efficient trial management.
The future of risk-based monitoring is about adopting an end-to-end, data-driven approach that uses new technologies and processes to deliver enhanced patient safety and quality. The triumph of people, process and technology bring greater confidence in decision-making as well as increased process efficiency and effectiveness.
Thomas Grundstrom, Vice President, Integrated Processes and Technologies and Global Head, Quintiles Infosario®
Thomas (Tom) Grundstrom is Vice President, Integrated Processes and Technologies, as well as the Global Head of Quintiles Infosario®. In this role, he oversees the design, development and adoption of Quintiles Infosario, which seamlessly integrates data, Quintiles’ systems, processes and therapeutic expertise to provide data transparency, optimized workflows and insights that drive faster, better-informed decisions.
Prior to this role, Tom served as Vice President of Global Data Solutions at Quintiles where he led the solutions team responsible for integrating Clinical Data Management, Central Labs, Cardiac Safety, Biostatistics, Phase I and Interactive Response Technology business units. Before joining Quintiles, Tom served in a variety of senior roles with both MDS Pharma Services and LabCorp. He has extensive experience directing the development of global systems in North America, South America, Europe, Australia and Asia.
A noted and sought-after speaker, Tom has led and participated in a variety of industry conferences, including panels at Drug Information Association (DIA) and U.S. Food and Drug Administration (FDA) events, among others.
Tom earned his bachelor’s degree from North Park University in Chicago, USA.Message Presenter
Amanda Sax, Senior Director, Integrated Processes and Technologies, Quintiles
Amanda Sax is Senior Director, Integrated Processes and Technologies. In this role, she oversees the data-driven processes that fuel Quintiles Infosario®, an innovative solution that seamlessly integrates data, Quintiles’ systems, processes and therapeutic expertise to provide data transparency, optimized workflows and insights that drive faster, better-informed decisions. In addition, Amanda leads the development of Quintiles’ approach to Risk-Based Monitoring, which optimizes the clinical trial execution strategy for each study to help customers manage risk and improve efficiency.
Prior to joining Quintiles, Amanda served as Senior Director of Clinical Data Management for AstraZeneca where she was accountable for the global delivery of data management through collaborative engagement of Clinical Development with a global BPO partner. She has also served as a director of Clinical Operations and Clinical Study Management.
Amanda began her career as a nurse at Middlesex Hospital in London and earned her degree in Clinical Science from Cardiff University in Cardiff, Wales.Message Presenter
Who Should Attend?
EVPs, VPs, Directors, Heads, Managers, Principal Scientists of:
- Clinical R&D
- Clinical Operations (Clinical Project Leads, Clinical Program Managers, Therapeutic Heads, Clinical Data Managers, Pharmacovigilance Scientist)
- Regulatory Affairs
- Medical Affairs
- Outsourcing Management
Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, and consulting solutions worldwide. The Quintiles network of more than 27,000 engaged professionals in 59 countries works with an unwavering commitment to patients, safety and ethics. Quintiles helps biopharmaceutical companies navigate risk and seize opportunities in an environment where change is constant. For more information, please visit http://www.quintiles.com/.