TransCelerate's Collaborative Approach to Risk-based Monitoring: The Methodology
Track
:
Track 21: Late Breaker
Program Code:
363
Date:
Wednesday, June 26, 2013
Time:
1:45 PM to 3:15 PM
EST
Location:
206AB
CHAIR
:
Craig Wozniak, (SPKNON), Head, Americas Clinical Operations, GlaxoSmithKline, United States
Craig has over 21 years of progressive experience in pharmaceutical drug development. He has held various positions in clinical operations, study management, quality assurance and data management. Experience includes multiple therapeutic areas with global Phase II-IV study design and delivery.
SPEAKER
(S):
Michael B. Luker, MBA (SPKNON), Senior Advisor, Eli Lilly and Company, United States
With 23 years pharmaceutical industry experience, Mike currently leads a diverse team of clinical research professionals dedicated to transforming clinical development at Lilly, and more broadly across the industry, via a portfolio of progressive and highly collaborative innovation initiatives.
Craig Wozniak, (SPKNON), Head, Americas Clinical Operations, GlaxoSmithKline, United States
Description
TransCelerate BioPharma Inc. (TransCelerate) developed a methodology for monitoring that shifts monitoring processes from an excessive concentration on source data verification to comprehensive risk-driven monitoring. This philosophical shift in monitoring processes employs centralized and offsite mechanisms to identify and monitor important study parameters holistically and uses adaptive onsite monitoring to further support subject safety and data quality.