The risk-based quality management (RBQM) approach moved the clinical research industry from a reactive, 100% verification model to a proactive, holistic, quality-by-design methodology. The approach is centered around risk management, central monitoring and metrics reporting. These activities are completed on a periodic basis, in addition to on-site and remote monitoring. The RBQM methodology has proven to raise quality and efficiency in the management of clinical trials. However, since it is not possible to stop all issues from occurring, a near-real-time issue identification and communication tool can further enhance the RBQM approach.
In this webinar, panelists will discuss the value of employing automation technology to increase awareness of issues that occur during a trial. We will review the areas in which clinical teams can be alerted so they may act on these issues before they become detrimental to trial outcomes. We will also present case studies of the benefits trials have experienced from implementing an automated alert system.
Speakers
Kristin Stallcup, MS, PMP, Senior Director, Xcellerate Customer Success, Covance
Kristin Stallcup brings 15 years of experience in various trial management capacities to her role as senior director for implementation and business process adoption of the Covance Xcellerate® suite. She previously led development and implementation of Xcellerate® Risk and Issue Management, and Xcellerate monitoring methodology and technology implementation. Stallcup holds an MSHS in clinical research management from George Washington University, a BS in molecular biology from Vanderbilt University, and Project Management Professional (PMP) certification.
Message Presenter
Gayle Keenan, BSc (Hons), MPhil, PMP, Senior Manager, Xcellerate Customer Success, Covance
Gayle Keenan has over 25 years of experience in clinical research working in clinical operations, project management and central monitoring. Currently she is a senior manager responsible for implementation and adoption of risk-based monitoring technologies and processes at Covance. Keenan completed her BSc in biochemistry and microbiology at the University of Leeds and her MPhil in immunology at Northwick Park Hospital. She is also a certified Project Management Professional (PMP).
Message PresenterWho Should Attend?
- C-Level in Clinical Trials Management
- Clinical Development Director
- Clinical Development Manager
- Clinical Operations
- Clinical Risk Manager
- Information System Management
- Information Technology
- Medical Director
- Operational Director
- Project Management
What You Will Learn
- The benefits of receiving notifications of events and issues as they occur so they can be quickly acted upon during a trial
- The types of alerts that can be set and how they can be used for effective trial management
- Case studies that demonstrate how instant alerts have helped teams improve study management
Xtalks Partner
Covance
Covance is a business segment of LabCorp, a leading global life sciences company, which provides contract research services to the drug, medical device and diagnostics, crop protection and chemical industries. Employing over 21,000 people worldwide, we are the world’s most comprehensive CRO, dedicated to improving health and improving lives.
Covance is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical, and regulatory expertise. We generate more safety and efficacy data to support drug approvals than any other company, supporting our clients’ complete lifecycle management.
Together with our clients, Covance transforms today’s healthcare challenges into tomorrow’s solutions. Visit us at www.covance.com.
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