Risk-based Monitoring Requires Changes to Leverage Data Insights

Clinical Trials, Life Sciences, Pharmaceutical, Pharmaceutical Regulation ,
  • March 31, 2015

Risk-based monitoring (RBM) is transforming clinical development. More and more studies are moving to using an RBM execution approach – which requires changes in processes and roles performed for data management, project management, clinical monitoring, site management, and more.

Putting the vast amount of data generated to use throughout a trial enables the right personnel, using the appropriate processes, to make faster, more informed decisions. Quintiles is executing >100 studies using RBM processes and procedures, with >20,000 sites and 250,000 patients, and will share some of the lessons learned in optimizing an operational model using innovative technology, advanced analytics with near real-time data for Centralized Data & Operational Surveillance.

By attending this free webinar, you will learn:

  • the proven model built for Data-driven Trial Execution
  • the use of technology for integrated data for holistic insights
  • new data review processes to improve patient safety
  • evolved roles and processes to optimize Site Management resources

Understand key lessons learned through years of experience using RBM procedures and processes to get to a global, scalable approach, proven to deliver higher efficiencies with improved data quality and patient safety.

Register now for this insightful and revealing webinar on proven Risk-based Monitoring executions.

Speakers

Yvonne Barnes, Senior Director, Clinical Operations, Quintiles

Yvonne has more than seventeen years experience working in strategic consultancy, operational leadership and partnership alliances within healthcare outsourcing organisations. Previously, she was the Chief Executive of a UK not-for-profit breast cancer research organization. Over the past 11 years of working at Quintiles, Yvonne has held increasingly senior positions within Strategic Account Management, Corporate Strategy and Clinical Operations. She currently leads the activities that make up the Site Monitoring and Cross-Functional Change Management components of Quintiles Risk-based Monitoring (RBM) offering. Yvonne has a BA in Business Studies from the University of Westminster, London.

Rajneesh Patil, Director, Clinical Development Productivity and Quality, Quintiles

Rajneesh Patil is a Director with Quintiles’ and has been with the organization for more than eight years. Rajneesh has overseen Data Management deliverables on large-scale global clinical trials portfolios for more than 117 protocols across five therapeutic areas. He is currently engaged in process and technology innovation, including advanced analytics, for clinical trial design and execution. His expertise spans program and project management, implementation of Clinical Data Management projects using global resourcing models, continuous process improvement and predictive analytics for clinical trials industry.

Rajneesh holds a Bachelors degree in Dental Surgery from India and Foundations in Public health from Australia. He is a certified Six Sigma Greenbelt, holds an MBA in Operations Management and Project Management Professional (PMP®) credential from the Project Management Institute, USA.

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

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Quintiles

Quintiles (NYSE: Q), a Fortune 500 company, is the world’s largest provider of bioPharmaceutical development and commercial outsourcing services. With a network of more than 32,000 employees conducting business in more than 100 countries, we helped develop or commercialize all of 2013’s Top 100 best-selling drugs on the market. Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of better healthcare outcomes. To learn more about Quintiles, please visit www.quintiles.com.

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