Recapping the Collaborative Webinar with 4G Clinical, Poxy Clinical, and Vir Biotechnologies
In the dynamic world of clinical trials and pharmaceuticals, staying ahead of the curve is vital. This is especially true when it comes to User Acceptance Testing (UAT) in the context of Interactive Response Technology (IRT) systems.
On September 7, 2023, representatives from 4G Clinical, Poxy Clinical, and Vir Biotechnologies collaborated to provide valuable insights into the strategies and best practices adopted by industry experts to ensure efficient and effective UAT in this ever-evolving landscape.
The webinar highlighted the evolving nature of the pharmaceutical industry, with technological advancements and the global pandemic driving significant changes. These changes have introduced complexities in protocol designs and shortened timelines. Consequently, UAT must adapt to these shifts by becoming more comprehensive, inclusive of real-world scenarios, and aligned with protocol requirements.
To begin, Helen Le, Senior Director of Quality Operations at 4G Clinical, described how GAMP-5 (Good Automated Manufacturing Practice) provides a framework for risk-based computer systems validation in the pharmaceutical industry. GAMP-5 emphasizes a risk-based approach, which is essential in identifying and addressing potential issues that could compromise patient safety, product quality, or data integrity. The updated edition of GAMP-5 acknowledges the shift toward agile development methodologies, emphasizing the importance of adaptability and critical risk-based thinking.
Panel Discussion: Lessons from the Field
The panel discussion provided valuable insights and lessons learned from real-world experiences in UAT of IRT systems. Susan Vong, President of Poxy Clinical, facilitated the discussion and was joined by Jordan Clark, Manager of Clinical Operations at Vir Biotechnologies, and Savannah Alford, Delivery Operations Manager at 4G Clinical. Key learnings included:
Navigating Complex Protocols
One key theme that emerged during the panel discussion was the increasing complexity of clinical trial protocols. “With increased protocol complexity, it becomes even more important to ensure that the system is designed to meet the needs of the protocol and is performing as expected,” said Jordan. She also pointed out that IRT functionality complexity is on the rise due to the adoption of complex protocol designs, cohort-driven studies, and platform trials. This complexity demands a heightened focus on system testing and the need for robust UAT.
Defining Roles and Responsibilities
The panelists stressed the importance of defining roles and responsibilities for the sponsor, IRT technology provider, and UAT partner early in the UAT process to ensure clear communication and efficient execution.
By delineating who is responsible for what, sponsors can streamline the testing process and hold team members accountable and ensure that UAT is not just a compliance exercise but a risk mitigation strategy.
Susan elaborated on this, saying, “Defining roles and responsibilities is fundamental to getting the process started. It can sometimes get daunting with multiple players involved, so knowing who owns each piece early in the process is critical.”
UAT Partner Collaboration
Collaboration with a third-party UAT partner, such as Poxy Clinical, was also discussed as a valuable resource. Jordan shared her positive experiences working with Poxy and 4G Clinical, highlighting how their expertise on technical aspects of the system allowed her team to focus on the overall system experience, saying, “It allowed us to focus on the overall output and behavior of the system and whether it meets the needs for the protocol that we have designed.”
The speakers also emphasized the importance of early involvement of UAT partners in the protocol design phase. By understanding the “why” behind protocol decisions, UAT teams can develop more robust test scripts and ensure a more comprehensive testing process.
Data Setup and Realistic Testing
Savannah emphasized the importance of realistic testing scenarios and data setup. Testing should not only encompass ideal scenarios but also consider real-world situations that could occur during the study. This approach helps sponsors ensure that the system can handle various scenarios effectively.
Savannah noted, “We want to ensure that these workflows we design are realistic for the sponsor and the site users to execute in the RTSM. Discussing these workflows in detail as part of design and envisioning how those system users are going to execute their activities post go-live provides some context and a baseline for the UAT preparation and testing.”
Streamlined UAT Process
The panelists highlighted the benefits of involving a third-party UAT partner in the requirements gathering and design phases. This collaboration helps streamline the UAT process and ensures that issues are addressed promptly and efficiently. Third-party UAT partners also bring an objective perspective, expertise in identifying high-risk areas, and the ability to streamline the UAT process.
This webinar provided valuable insights into the evolving landscape of UAT in the pharmaceutical industry. Collaboration, risk-based thinking, realistic testing, and early involvement of UAT partners emerged as key strategies to ensure successful UAT and compliance with industry regulations. As the pharmaceutical industry continues to evolve, these insights will be invaluable for stakeholders seeking to navigate the complex world of UAT and risk mitigation in clinical trials.