Top Considerations for IRT Audit Data Management

In recent years, there has been an increase in regulatory scrutiny from clinical trial governing agencies, with a particular focus on the validation of computer systems and the need for verification of data integrity and reliability through audit trail review. This heightened attention has created the need for sponsors to understand their IRT audit data more completely and create a plan for management. Join Endpoint Clinical’s VP of Data and Quality, Cat Hall, as she dives into IRT audit log data, the regulations and guidelines, and top things to consider when building your IRT Audit Data Management Plan.

Speakers:

Catherine Hall
VP, Data and Quality
Endpoint Clinical

Cat Hall started her career as an Academic Scientist before finishing her MBA and transitioning into pharmaceutical supply chain management. Cat has developed notable expertise not only in clinical supplies but also in training development, process improvement, managing partnerships, and the design and implementation of technologies such as IRT. She is well-known for focusing on bridging the GMP/GCP gap by bringing supply chain customer service through the last mile to patients. Cat joined Endpoint in 2019 as VP of Product Strategy, and currently serves as VP of Data and Quality.