The Evolving Role of Data Management in Risk-Based Monitoring

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, Global Data and Safety Monitoring, 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, Clinical Development Productivity and Quality, Quintiles will share insights on the evolving and critical role of data management in RBM studies.

Speakers

Crona O’Conallain, Director, Global Data and Safety Monitoring, Quintiles

Crona O’Conallain holds a B.Sc. and Ph.D. in Biochemistry from University College Dublin (UCD). She spent a further 2 years at UCD performing post-doctoral research in the area of Molecular Genetics before joining Quintiles as a Data Manager in 2000.

Crona has held numerous leadership positions with her 14 years in the Quintiles Global Data Management organisation, and is now on the Quintiles’ leadership team for Risk Based Monitoring, leveraging her Data Management experience in supporting the development of a Centralised Data and Operational Surveillance (CDOS) organisation that drives the RBM model.

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

In his 8+ years with Quintiles, Rajneesh Patil 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 for clinical trial design and execution, utilizing his expertise in program and project management, implementation of Clinical Data Management projects using global resourcing models, and continuous process improvement and predictive analytics for the 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.

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