Risk-based Thinking: The Success of Risk-based Monitoring Begins with Risk-based Thinking

Clinical Trials, Life Sciences, Pharmaceutical,
  • July 19, 2013

Risk-based thinking starts with having the right stakeholders at the table to ask—and answer—the right questions. We will explain how safety and therapeutic medics, biostatisticians, data management experts and operations gurus apply risk-based thinking before a trial begins.

We will review the two types of risk in risk-based monitoring – scientific risk and operational risk, highlighting:

  • Efficacy risk and scientific outcomes
  • Patient/safety pathways and patient risk
  • Conduct and data integrity risk

The webinar will also discuss the design and set up of alerts and triggers against various parameters of data integrity, efficacy, and operational execution. With these insights, you can see how you are performing and trigger activity to protect against risk throughout a study, improving productivity and efficiency, while enhancing patient safety and study quality.

Speakers

Rick Sax, M.D., Senior Vice President, Integrated Clinical Services, Quintiles

Frederic “Rick” Sax leads Quintiles’ dedicated planning and design unit, the Center for Integrated Drug Development, supporting customer need for clinical program designs. The unit provides design expertise at every step of the drug development spectrum to help partners make knowledge-based decisions about the benefit-risk-value trade-offs of their compounds. Sax also leads Quintiles’ Integrated Clinical Services division, comprised of Cardiac Safety Services, Biostatistics, Medical Writing, Regulatory Affairs and Lifecycle Safety.

Sax joined Quintiles from AstraZeneca’s clinical development leadership team where he served as VP, Clinical Design Strategies. For more than a decade, Sax has led the design of solutions to enhance the quality of program and trial design while driving efficiencies in cost, time and process. Sax’s career spans nearly 20 years in the bioPharmaceutical industry. Prior to joining the industry, he served as an academic cardiologist. Sax graduated with a B.A. in Biology and Philosophy from Yale University, and an M.D. from Columbia University.

Dan White, Vice President, Global Operations, Quintiles

Dan White is Vice President of Global Operations for Quintiles centralized monitoring group (PCC) as well as the endpoint adjudication group (CEVA). In this position, Dan leads over 26 PCC locations around the world including centers in Latin America, Eastern/Western Europe, Australia, South Africa, India, and the US (largest center). Dan is Quintiles subject matter expert on risk-based monitoring, working with sponsors on the implementation of risk-based monitoring across Quintiles organization. Dan has been with Quintiles over 13 years and is based in NC out of the RTP office.

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

Xtalks Partners

Quintiles

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 www.quintiles.com.

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