Clinical research systems support various business functions and processes within a sponsor organization, and are classified differently from a regulatory compliance perspective based on their intended use. If data is submitted to the Food and Drug Administration (FDA), the system used to capture this data must be validated. By leveraging a risk-based validation methodology, you can tailor your validation strategy to the specific type of system and implementation nuances; assigning practical validation roles and responsibilities. In this webinar, senior associate, Susan Nonemaker-Cox, will provide an overview of a typical validation checklist and risk-based validation considerations both the sponsor and vendor should follow during clinical research system implementation.
You’ll learn how to:
About the Presenters:
Susan has over 20 years working in clinical and research IT. She has managed international Electronic Data Capture (EDC) and Clinical Trial Management System (CTMS) implementations while working in a regulatory compliant environment. She also led the Computer Systems Validation practice for a New York-based management and IT consulting firm. Susan has directed projects across a wide variety of domains, including global business technology management, metrics and process reporting, software testing and release management, and computerized system validation. Susan acts as Essex’s CTMS Domain Lead, heads Essex’s Validation Practice, and serves as a Program Manager for the National Cancer Institute. Susan holds a Bachelors in Speech Communication with a concentration in Marketing from Shippensburg University.
Tami is the Product Marketing Manager for Overture EDC at Forte. Overture is a user-friendly electronic data capture system with an elegant design and easy-to-navigate user interface, that fully supports compliance with 21 CFR Part 11.