Site Quality Management and Risk-Based Monitoring: A New Approach
Presenter: Stephen Young
In today’s pressure-packed environment, the quest for improved data quality at a lower cost is of paramount importance to all clinical organizations. A risk-based model for monitoring has become a growing and crucial component in this search. This webinar will break down the issues related to the implementation and tracking of a risk-based monitoring program through the utilization of site quality management.
Key learning points of the webinar:
- Learn the role of data quality and metrics in the adoption of risk-based monitoring;
- Interpret regulatory agencies’ guidance on risk-based monitoring;
- Address challenges in adopting a risk-based approach;
- Understand the concepts underpinning a site quality management program; and
- Gain a background on what's needed to implement risk-based monitoring with centralized site quality management.
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Senior Product Director
Medidata Solutions Worldwide
Stephen Young is Senior Product Director at Medidata Solutions Worldwide. Stephen brings more than 15 years of experience in driving change and implementing technologies within clinical development organizations, most recently as head of eClinical Services for J&J Global Clinical Operations. In his current role, Stephen leads Medidata’s, Visualization, Analytics and Reporting portfolio of products, which includes Medidata InsightsTM, a SaaS business analytics solution providing customers with key metrics and analytics across the clinical research process. Stephen received his BSc in Mathematics from St. Joseph’s University and his MA in Mathematics from Villanova University.
About Medidata Solutions Worldwide
Medidata Solutions is a leading global provider of SaaS clinical development solutions that enhance the efficiency of customers’ clinical trials. Medidata’s advanced solutions lower the total cost of clinical development by optimising clinical trials from concept to conclusion: from study and protocol design, trial planning and budgeting, site negotiation, clinical portal, trial management, randomisation and trial supply management, clinical data capture and management, safety events capture, medical coding to business analytics. Our diverse life science customer base spans biopharmaceutical companies, medical device and diagnostic companies, academic and government institutions, CROs and other research organisations, and includes more than 20 of the top 25 global pharmaceutical companies as well as organisations of all sizes developing life-enhancing medical treatments and diagnostics.
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