Description
The novel coronavirus that causes COVID-19 has had a significant impact on 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 released a list of recommendations to maintain oversight of clinical trials during this public health crisis.

In this free webinar, our speakers will expand on these recommendations and discuss actionable next steps for sponsors to optimize the knowledge and resources 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 can be adapted to continue in the current situation and what possible lessons can be learned after the COVID-19 situation ends.

The session will conclude with an open question-and-answer discussion.

About the speakers
Nicole Stansbury, VP Central Monitoring, Syneos Health

Stansbury joined Syneos Health in February 2019. She has 26 years of industry experience, starting as a study coordinator at a multi-therapy facility, 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 taking on a took on a leadership role where she led the development of the risk-based monitoring (RBM) strategy, processes and tools. Stansbury has consulted with biotech companies on ICH E6 R2 compliance, provided risk management training, conducted detailed assessments of EDC, CTMS, RBM and eTMF technologies for a small CRO, and completed a risk management and centralized monitoring process review for a large pharmaceutical company.

Stansbury's achievements 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 in ACRO's RBM Forum, presenting 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 industry experience and began her career as a Clinical Data Associate for a major pharmaceutical company, where she worked for 25 years in various data management roles before moving into leadership positions. Hughes has a total of 21 years of leadership experience in biometrics/clinical operations leadership positions. Hughes currently leads the global Data Operations organization consisting of more than 700 data management and clinical programmers who support the delivery of the full service portfolio across all therapeutic business units.

Hughes holds 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).

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