Written by: Kayla Burrell, MS, CSM
Presentation Overview
On September 12, 2024, the Clinical Research Forum of the PMI Atlanta Chapter hosted the “Strategies for Effective IRT Vendor Management in Clinical Trials” forum event by Gayle Flynn. Ms. Flynn spoke to the audience and shared some key knowledge about best practices for Interactive Response Technology (IRT) vendor management that can help sponsors and study teams achieve their objectives and ensure compliance with regulatory standards. Those best practices are through proper vendor management, project management, communication, risk management, compliance, training, and support.
Ms. Flynn explained that IRT is a system used in clinical trials to manage patient randomization, drug allocation, and inventory tracking. IRT increases efficiency, provides up-to-date patient enrollment information, and helps ensure regulatory requirements adherence. Ms. Flynn broke down the best practices for IRT vendor management as follows:
- Vendor Selection: The importance of the vendor's experience, technical capabilities, regulatory compliance, and support will determine the vendor’s capabilities and ability to tailor solutions to your specific needs.
- Project Management: It establishes clear project timelines and milestones and tracks the progress and performance of the vendor.
- Communication: Establishing and maintaining clear and consistent communication with the vendor and the study team to promptly address any issues or changes.
- Risk management: Properly identify and mitigate potential risks and challenges that may arise during the study and prepare contingency plans.
- Compliance: 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: Provided to the study team and the site staff to help ensure user satisfaction and feedback.
Takeaways
- All it takes is one glitch to cause a quirky issue with IRT to bring an entire clinical study to a halt. That is why it is important to follow best practices and implement effective strategies.
- Additional strategies that have been proven effective in ensuring success with IRT are implementing monitoring and quality control, change management, and post-implementation review measures such as lessons learned and strengthening ongoing relationships.
Next Event
Join us at the next PMI Atlanta Chapter Clinical Research Forum on Thursday, November 14, 2024.
Keynote Presentation: TBD
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