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Session 5 Track 3 - Connection with CROs
Session Chair(s)
Michelle L. Charles, MPH
Director, Regulatory Affairs, Gene Therapy Program
University of Pennsylvania, Perelman School of Medicine, United States
More often than not, sponsors are working with CROs to execute programs, trials, or functional tasks. This session will bring varied scenarios of CRO responsibilities and technology interaction. Data and documentation at clinical sites has long been a collection of paper, electronic, and portable digital mediums. Ensuring the completeness and quality of the site records has traditionally involved on-site monitoring model, but the size, complexity, and number of clinical trials mean that complete on-site monitoring is becoming an ineffective, expensive, and inefficient process. Alternate methods for remote monitoring will be explored. In addition, how can essential document management be utilized to enable CRO accountability and what are the best options to ensure compliance? Is there a benefit to both a sponsor and a CRO maintaining separate eTMFs? Is it too much of a good thing? What are industry and compliance driven best practices for a dual system model.
Learning Objective : •Discussion on Regulations for Clinical Monitoring •Practical difficulties/issues faced by sponsor/CRO, during monitoring : Case Studies •How to formulate most efficient monitoring plan •Execution of remote monitoring in flexible manner, despite achieving purpose of monitoring
Speaker(s)
Implementing Risk Based Monitoring Approach to Clinical Trials
Ashok Ghone, PhD
MakroCare, United States
VP, Global Services
Essential Document Management - Using Metrics to Drive Compliance and Provide Oversight
Kelley Robinson
Pfizer, United States
TMF/Registry Process Analyst
eTMF – Options for the Sponsor When Working With A CRO
Paul Nalepa
PPD, United States
Assoc. Manager, Information Governance & Compliance, Global Quality & Compliance
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