The novel coronavirus that causes COVID-19 has significantly impacted the conduct of clinical trials, especially on-site monitoring. In response, the Association for Clinical Research Organizations (ACRO) and its member companies, including Syneos Health, have issued a list of recommendations to maintain Clinical Trial Monitoring Oversight during this public health crisis.
In this free webinar, our featured speakers will expand upon these recommendations discussing actionable next steps for sponsors to optimize the knowledge and resources that are immediately available to them, including remote and centralized monitoring tools to ensure data quality, site support and patient safety. They will consider the ways in which clinical trial monitoring may adapt to continue in the current situation and potential learnings after the COVID-19 situation ends.
The session will end with an open question and answer discussion.
Nicole Stansbury, VP Central Monitoring, Syneos Health
Stansbury joined Syneos Health in February 2019. She has 26 years of experience in the industry beginning as a study coordinator at a multi-therapeutic site followed by 21 years at a large, global CRO where she spent several years as a Clinical Research Associate (CRA) and Project Manager (PM) before moving into a leadership role where she led development of risk-based monitoring (RBM) strategy, process and tools. Stansbury has consulted with biotech companies on ICH E6 R2 compliance, conducted risk management training, performed detailed assessments of EDC, CTMS, RBM and eTMF technologies for a small CRO and completed a risk management and centralized monitoring process assessment for a large pharmaceutical company.
Stansbury’s achievements and accomplishments include a yellow belt in Lean Six Sigma, completion of a Global Leadership program, recipient of the 2011 CEO Leadership Excellence Award, meeting with the FDA in 2014 to share RBM strategy ideas, participation on ACRO’s RBM Forum, presentation at numerous industry conferences on RBM and publishing several articles on RBM and Change Management.
Jackie Hughes, SVP Data Operations, Syneos Health
Hughes joined Syneos Health in September 2014. She has 31 years of experience in the industry starting her career as Clinical Data Associate for a large Pharmaceutical company where she worked for 25 years undertaking numerous Data Management roles prior to moving into leadership positions. Hughes has a total of 21 years leadership experience in Biometrics/Clinical Operations leadership positions. Hughes currently heads up the global Data Operations organization consisting of over 700 Data Management and Clinical Programmers supporting delivery of the Full Service portfolio across all Therapeutic Business Units.
Hughes has a green belt in Lean Six Sigma, completed a Global Leadership program, received the 2003 Operational Excellence Director honorary title, 2009 CEO award for ’Outstanding Team’, 2009 Clinical Research Excellence Award for ‘DM team of the year’, Good Clinical Practice journal, 2009 Outsourcing End-User of the year and National Outsourcing Association awards and 2009 ‘Best Supplier- Purchaser Collaboration’ award, Chartered institute of Purchasing and Supply (CIPS).
Who Should Attend?
The webinar may be of interest to:
- Sponsors whose sites have suspended or restricted all visitors from accessing medical facilities, but are still conducting patient visits
- Local health officials
- Local CRAs who are unable to travel to their sites
What You Will Learn
The presentation will consider the following questions:
- How is COVID-19 impacting monitoring in clinical trials?
- What are some ways that monitoring can continue in this current situation?
- What might have to change related to EDC process and workflows?
- What about studies nearing Database Lock?
- What should we do after the COVID-19 situation resolves?
Syneos Health® (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. The Company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. We bring together approximately 24,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. To learn more about how we are shortening the distance from lab to life®, visit syneoshealth.com.