CRO Oversight 101: Best Practices to Reduce Outsourcing Compliance Risk

In a clinical environment where studies are increasingly complex and sponsors continue to outsource trials to contract research organizations (CROs), it’s even more important that clinical trial management systems (CTMS) and other clinical systems ensure sponsors are compliant with oversight requirements.

Sponsors must demonstrate that they are actively managing the oversight of outsourced studies and ensuring subject safety, as the ultimate responsibility for trial conduct and quality lies with the sponsor. Failing to demonstrate proper oversight can result in regulatory findings, trial delays, and even study shutdowns.

In this free webinar, featured speakers will discuss:

• Best practices to ensure oversight in an outsourced model
• Top areas, key risk indicators, and key performance indicators recommended for tracking proper oversight and CRO governance
• Tips and tricks to get more from your oversight CTMS application

Speakers

Henry Galio, Senior Director, Vault CTMS, Veeva Systems

Henry Galio is responsible for the overall market strategy and direction of the Veeva Vault CTMS application. With over 30 years of experience in life sciences and 18 years in developing and implementing clinical trial systems and clinical data analytics, Henry is an expert in clinical operations software, business process optimization, and CTMS efficiency. Before joining Veeva, Henry spent 10 years working at top 10 pharma and biotech companies. He then spent 18 years working for leading software companies including Siebel, IBM, and Oracle, where he held a wide variety of consulting, architecture, sales, and strategy roles. Over the course of his career, Henry served as an advisor and implementer of CTMS solutions for hundreds of life sciences companies and has spoken internationally on CTMS, clinical integration, clinical data warehousing, the clinical internet of things, and personalized medicine.

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Ed Dougherty, Senior Solution Consultant, Veeva Systems

Ed Dougherty has been in the life sciences and clinical development technologies space for over 20 years with a focus on operations, data management, and data warehousing. Ed has been with Veeva for the last 18 months. Prior to joining Veeva, he spent 10 years working with leading technology vendors Medidata Solutions and Oracle Health Sciences, in a variety of client-facing roles. Ed has a Master of Science in Information Science from Penn State University.

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