Clinical Research (Virtual) Forum - 240912

"Strategies for Effective IRT Vendor Management in Clinical Trials" presented by Gayle Flynn, Engagement Delivery Partner at Cognizant

The Clinical Research Forum provides value to the PMI Atlanta community by regularly discussing the various aspects of clinical trial projects with special focus on the need to anticipate, understand, and implement detailed project management activities in a proactive manner for clinical trials in the pharmaceutical industry.

Presentation Details

Interactive response technology (IRT) is a key component of clinical trials that enables randomization, drug supply management, and data collection. Choosing and managing the right IRT vendor can significantly impact the quality, efficiency, and success of a clinical trial. However, managing IRT vendors can be challenging due to the complexity, variability, and unpredictability of clinical trials. In this talk, we will discuss some best practices for IRT vendor management that can help sponsors and study teams achieve their study objectives and ensure compliance with regulatory standards. We will cover the following topics:

• Vendor selection: how to evaluate the vendor's experience, technical capabilities, regulatory compliance, and support.
• Project management: how to establish clear project timelines and milestones and track the progress and performance of the vendor.
• Communication: how to maintain clear and consistent communication with the vendor and the study team and address any issues or changes promptly.
• Risk management: how to identify and mitigate potential risks and challenges that may arise during the study and prepare contingency plans.
• Compliance: how to ensure that the IRT system meets the industry standards and regulations, such as ICH E-6, ICH E-9, and 21 CFR Part 11, and undergoes rigorous testing and validation.
• Training and support: how to provide comprehensive training and ongoing support to the study team and the site staff and ensure user satisfaction and feedback.

We will also present some case studies that illustrate the strategies in action and highlight the importance of a proactive and collaborative approach to keeping the studies on track and ensuring high-quality outcomes.

Biography    

Gayle serves as an Engagement Delivery Partner at Cognizant, where she has been employed for the past nine years. She has worked in clinical research for more than 20 years. Before joining Cognizant, Gayle held positions of increasing responsibility at Pfizer, PPD, Quintiles and GSK. Gayle is known for driving innovation and transformation in the IRT and clinical supplies space and has earned a reputation as a dynamic, people, and patient-focused solutions-oriented leader.

Gayle was recognized as a Health Care Businesswomen’s Association (HBA) Luminary in 2021. She credits her success in the industry to creating strategies with a patient-first mindset while building highly competent diverse teams that can flawlessly execute against those strategies.
Gayle's influence extends far beyond her current role. Alongside her position at Cognizant, she has a regular presence at major industry events, presenting at prestigious conferences such as the Society for Quality Assurance Annual Meeting (SQA), Interactive Response Technologies (IRT), and the Society for Clinical Research Associates (SOCRA).

Outside of her professional endeavors, Gayle is deeply involved in her community. She is a community leader for the Raleigh Women in Technology Network (WIT), a Cognizant Outreach Coordinator for the Raleigh Durham area, and the Marketing Director at Large for the Raleigh chapter of HBA.

When

Thursday, September 12, 2024, 6:00 PM - 7:15 PM

Where

Webinar

You will receive an email from the PMI Atlanta Chapter with the webinar link 24 hours before the event start time.

Fees

Members $10
Non-Members $12

Meeting content, presenter, and location are subject to change. Refunds will not be made for changes in meeting content, presenters, or locations.

PDUs

Earn 1 PDU
Talent Triangle Category: Ways of Working