The push to implement risk-based monitoring is continuing across the industry, yet many sponsors are struggling to find the right methods and technology to implement risk-based monitoring, resulting in a time consuming and expensive effort.
Risk-based monitoring provides significant value by increasing visibility to potential risks and improving the sponsors’ ability to catch issues early. Enabling a variety of methods, including central monitoring, risk-based monitoring promotes better oversight of both site and CRO performance.
With clear value to offer, why are so many companies still struggling to put risk-based monitoring strategies into place? Too often it is because the requirements are unclear, technologies offered are costly, and the processes to implement them are cumbersome. As a sponsor, your time is limited and you need an efficient and effective way to implement risk-based monitoring and realize the value it offers.
Speakers
Joe Barraquio, Portfolio Manager, Quartesian
Joe Barraquio has over 15 years of experience in the life sciences industry where he has held numerous leadership positions overseeing multidisciplinary cross-functional teams some of which have included clinical operations, project management, data management, biometrics, and regulatory affairs. Joe currently serves as Portfolio Manager at Quartesian where he provides senior level management, guidance, and support to project teams involved in clinical data management, biometrics, and medical writing activities.
Prior to joining Quartesian in 2014, Joe worked with WCCT Global (formerly West Coast Clinical Trials) where he was a member of the leadership team that helped drive the company’s growth and expansion as a small Phase 1 clinical unit to a full-service CRO capable of supporting sponsors on a full range of services covering drug development. Joe holds a Master’s Degree in Applied Biostatistics & Epidemiology from the University of Southern California and a Bachelor’s Degree in Biology from the California State University of Long Beach.
Message Presenter
Courtney McBean, Guest Speaker and Owner of Cascadia Global Research and RBMessentials.com
Guest speaker Courtney McBean, of Cascadia Global Research and the training platform www.RBMEssentials.com, has more than twenty years of experience as a clinical researcher and cross-functional business leader. Her experience spans medical device, pharmaceutical, and NIH-funded trials. With extensive expertise in risk-basedmanagement, designing clinical operations strategies, and developing training programs, she helps individuals and organizations create achievable strategies.
Courtney is a pioneer in the area of risk-based monitoring systems. In 2012 she founded Blueprint Clinical – the innovative company that created the Compass Intelligent Monitoring solution which was acquired in 2014. Her company won several awards, including Gartner 2014 Cool Vendor in Life Sciences and the Society for Clinical Data Management Technology Innovation Award. Now, she focuses on helping companies develop strategies and processes to execute risk management and develop the knowledge and skills necessary to be successful.
Courtney’s goal is to help clinical trial professionals develop the knowledge and tools they need to perform with clarity, focus and efficiency in order to maximize their impact.
Message Presenter
Who Should Attend?
Professionals from life sciences companies, including CROs, sponsors and monitors, involved in:
- Clinical Leadership
- Clinical Operations
- Data Management
- Quality Assurance
- Regulatory
What You Will Learn
This webinar will show you how you can implement risk-based monitoring efficiently and affordably using the right strategy and technology. Featured speakers will:
1) Clarify the essential components you need for a complete and efficient risk-based monitoring strategy. Do you know the components your risk-based monitoring strategymust include? This webinar will outline the key elements you need in a risk-based monitoring plan so you can gain clarity and focus on the essentials.
2) Demonstrate how you can implement risk-based monitoring efficiently and affordably with the right technology. Central monitoring is a key component to your risk-based monitoring strategy, yet the technology to support central monitoring often comes with a high price tag and a long lead time to implement.
3) Teach you what need to look for in an effective central monitoring technology. Attendees will also see Quartesian central monitoring system in action and learn how it can help you efficiently implement central monitoring as part of your risk-based monitoring strategy.
Xtalks Partner
Quartesian
Quartesian was formed in January 2003, headquartered in Princeton, N.J. with the goal of providing “Clinical Data Your Way” to its clients. This is accomplished by providing clinical data services faster, more efficient and cost-effective than ever thought possible. The founding members of Quartesian rely not only on their technical expertise, but on their experience as past clients of clinical service providers. Quartesian prides itself on its flexibility, responsiveness, adherence to client specifications and timelines for all projects conducted anywhere in the world. We have worked for over 125+ pharmaceutical, biotechnology and medical device companies with 100% repeat business and no change orders.
Our business model brings together domestic and off-shore staff with minimum overhead and maximum efficiency within a framework of validated computer systems, regulatory compliance and industry best practices. Our long company history, wide geographic presence, high quality standards, cost effectiveness, faster turnaround time, and therapeutic expertise as well as qualified, experienced and talented employee capabilities enhance our client benefits.
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