SOURCE: Xtalks

Xtalks Webinars

October 07, 2014 07:05 ET

The Evolving Role of Data Management in Risk-based Monitoring, Live Webinar Hosted by Xtalks on Thursday, October 16, 2014 at 11am EDT (NA) / 4pm BST (UK GMT +1)

TORONTO, ON--(Marketwired - October 07, 2014) - Clinical Development is moving more trials to a risk-based monitoring (RBM) approach. Core to the success is leveraging data from numerous functions and putting real-time data to use across the study. Knowledge created from holistic clinical trial insights are improving efficiency in clinical development through timely, integrated data, enabling the identification of potential issues faster than previously possible -- but changes are required in how we integrate processes and change roles.

Data management has become an increasingly critical role in the execution of clinical trials, and while RBM seems to focus on the impact to monitoring, data management must evolve to optimize results, including:

  • Improved data quality and patient safety
  • Integrated data for holistic trial insights
  • Identification and mitigation of risks
  • More predictable trial outcomes

Risk-based monitoring requires timely 'analytic ready' data to make faster, more informed decisions, or take action faster, which can improve patient safety throughout a trial. Operationally, by having the right resources reviewing the critical data points at the right time, risk can be re-assessed and adjusted using the insights from this analysis, improving the probability of your success. Utilizing a holistic view of data to capture new levels of trial insights will continue to promote the use of an expanded risk-based monitoring model is transforming clinical development.

Technology is a key enabler of risk-based monitoring implementations. Historically, trial data has been collected in silos based on the role each team was performing. By integrating data from pipeline to patient, the traditional roles are adapting to leverage their expertise to deliver new levels of insights which can improve safety, costs, timelines and outcomes.

The methodologies involved in executing risk-based monitoring are changing the execution of clinical trials, and having an impact on the roles critical to the delivery of quality outcomes. By attending this webinar, you will:

  • Understand how Data Management is evolving as a critical element of risk-based monitoring
  • Hear industry experts explain how the roles of Data Management are becoming more critical due to newer and more sophisticated methods of real-time data analysis
  • Learn how technology is enabling shifts in how data is used
  • Learn how medical practitioners are using data analytics to create a knowledge-based model of predicting trials that contribute to improvements in the speed, quality and outcomes of trials
  • Gain insights into how Clinical Development is benefitting from these changes

Crona O'Conallain, Director of Global Data and Safety Monitoring at Quintiles, is a global leader in Quintiles RBM strategy and will discuss how data is a critical driver in executing a trial using risk-based monitoring methodologies. Rajneesh Patil, Director of Clinical Development Productivity and Quality at Quintiles, will share insights on the evolving and critical role of data management in RBM studies.

To learn more about this event visit: The Evolving Role of Data Management in Risk-based Monitoring

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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Contact Information

  • Xtalks
    Michelle Tran
    Tel: +1 (416) 977-6555 ext 352
    Email: mtran(at)xtalks(dot)com