By: Vincent Puglia, RTSM Strategy | Community Director
Introduction:
Onboarding is vital for the smooth conduct of clinical trials in today’s dynamic environment. In a recent Veeva RTSM webinar, we explored the details of an onboarding model that demonstrates excellent sponsor oversight. This method simplifies the onboarding process and enables all stakeholders to perform well in their roles. As the moderator, I was privileged to guide a discussion that highlighted how such a model can foster collaboration and enhance the overall efficiency of clinical trials.
Event:
- Title: Onboarding Strategies for Success at Any Speed in RTSM
- Date: May 2, 2024
- Panelists:
- Susan Schneider: Associate Director of Clinical Trial Supply, Pacira Biosciences
- Joe Cooney: Associate Director of Clinical Systems, Pacira Biosciences
- Meghan Sneed: Project Manager, Veeva RTSM
1. The Foundation of Excellence: Pre-Kickoff Preparation
Effective RTSM onboarding starts with thorough preparation. Susan emphasized the critical nature of being well-prepared, especially when managing multiple studies concurrently. This approach ensures that Clinical Trial Managers (CTMs) are ready and knowledgeable about new RTSM systems and timelines, facilitating a smooth transition.
Meghan discussed the proactive steps taken even before the kickoff meeting, such as gathering information and preparing the initial design. This early engagement sets a solid foundation, allowing the team to commence the kickoff meeting with a well-structured plan.
Joe also highlighted the significance of aligning system expectations and processes, particularly for integration points like EDC and RTSM. This proactive approach not only facilitates smoother transitions but also builds a strong framework for subsequent stages of the project.
Key Points:
Main Takeaway: Early preparation sets a solid foundation for successful onboarding. |
2. Engaging Stakeholders to Foster Excellence
A key aspect of the sponsor oversight model is effective stakeholder management, which ensures seamless collaboration and alignment across teams.
Meghan noted the benefits of having a small, efficient team, which facilitates easier communication and cohesive teamwork. Meghan also spoke to the specific experience of onboarding a new provider and acclimating everyone for success:
“For me, a lot of it is about talking to them based on their role especially when you’re onboarding someone who is new to the system. You guys [Sponsor] aren’t new to the RTSM systems but you are new to the Veeva system, so what I really like about the way we do our designs is we build the study right away so it gives me a space to show, make recordings, get screenshots and show them [end users] how it looks to them.”
Susan described their core team structure, which includes CSM, CTMs, CPMs, CTAs, CRO associates, CRAs, and Depots/Distribution. Additionally, she emphasized the importance of including QA teams to understand the RTSM system’s workings, even if they do not directly interact with it. Susan demonstrated a holistic viewpoint as well by stressing the importance of keeping even those with minimal system contact well-informed, ensuring they have the necessary access and understanding when their involvement is critical.
Susan also emphasized the importance of early stakeholder involvement in system transitions to avoid surprises. She shares an example where a vendor preferred FTP over email, and they adapted by sending emails via FTP. Early engagement ensures a smooth transition and uncovers issues they might not have noticed otherwise.
Role Acronyms:
Key Points:
Main Takeaway: Early and effective stakeholder engagement ensures smooth transitions and collaboration. |
Kickoff Meetings: The Launchpad for Success
The kickoff meeting is a critical juncture in the RTSM onboarding process. Meghan described their approach, which involves presenting a well-defined timeline and addressing design questions early. This transforms the kickoff meeting into a productive working session, setting a
collaborative tone from the outset. Starting in this way ensures that the first iteration of the system build is as accurate as possible, based on the questions and inputs gathered during these meetings.
Susan appreciates and recommends a structured approach to kickoff meetings, which includes a detailed timeline outlining all requirements, allowing participants to understand their commitments and map out their availability effectively. This proactive approach facilitated smoother transitions and more efficient handling of tasks.
Susan noted a key takeaway:
“We started getting people used to understanding the documents and the requirements that they have to do for signing off, so they’d have to get access to different systems…and we could do that ahead of time. So when it came to signing off on something, it wasn’t, oh wait, I don’t have access, I don’t know what I’m doing.”
In discussing the preparation for kickoff meetings from a systems perspective, Joe shared his approach to aligning system expectations and organizational processes. His involvement in both RTSM and EDC kickoffs proved beneficial, particularly in understanding and planning for integration timelines. This preparation ensured that the Data Management (DM) team was well-prepared and that key integration details, such as the types of variables to be passed between RTSM and EDC, were clearly defined and understood.
Key Points:
Main Takeaway: Kickoff meetings are critical for setting a collaborative tone and ensuring an accurate system build. |
4. Standardizing Integration to Enhance Collaboration
Integrations are a key component of any clinical trial, and our panelists shared valuable insights on handling them effectively. Joe emphasized standardization is key to maintaining clarity and efficiency in integration processes, and that standardizing Case Report Forms (CRFs) and data transfer specifications helps resolve inconsistencies and ensures smooth integration. This approach allows teams to focus more on collaboration rather than troubleshooting. Joe explained how being able to identify inconsistencies early and communicate across a program of studies increases efficiency, “we were able to be consistent [across] all three trials and we could share that information between each other… get ahead of those things”.
Meghan shared a lesson learned from their experience: assigning a single Configuration Consultant for multiple trials helps maintain consistency, minimizing discrepancies and enhancing the seamless integration process.
Key Points:
Main Takeaway: Standardization simplifies integration and fosters better collaboration. |
5. Flexible UAT: Empowering Thorough Testing
User Acceptance Testing (UAT) is a critical phase that tests the system’s readiness for production. Megan outlined a structured approach to UAT, providing tailored test scripts and maintaining open lines of communication to address any issues promptly. The use of a visible log to track issues and their resolutions was particularly beneficial, enabling team members to stay informed about the status of reported problems and avoid redundant entries.
Susan described their tiered testing process, which includes leveraging scripts for different user levels, ensuring comprehensive testing and allowing each stakeholder to focus on their areas of expertise.
Daily open-line meetings further enhance this collaborative model, providing a platform for quick resolution of any issues, which keeps the testing phase aligned and effective. Susan and Joe both appreciated the flexibility and support provided during UAT, which allowed them to test the system thoroughly and resolve any issues quickly. Meghan gave context to the simple but direct and effective approach:
“no one had to come on it…Susan, Joe, and their team could just pop in if they had a question…so we could address it really quickly.”
6. Go-Live and Beyond: Sustaining Excellence
Flexibility and continuous support are crucial for a successful go-live strategy. Susan noted that aligning RTSM and EDC timelines effectively ensures a smooth go-live process and shared her experience of adjusting go-live timelines based on the readiness of EDC integrations. Demonstrating the importance of coordinating with all system components to ensure a smooth launch allows teams to dynamically respond to changes while maintaining project momentum.
Joe appreciated the model’s responsiveness, highlighting the quick turnaround on post-production issues as invaluable. This continuous support ensures that teams can swiftly adapt and resolve issues, sustaining high performance throughout the trial.
Joe included a recent example:
“Just yesterday we had a little issue in our UAT data and our subject ID uniqueness when entering casebooks in UAT, and within less than a day I was able to get you [Veeva RTSM lead], our EDC lead from Veeva, our CRO EDC designer and everyone on a call quickly. We ironed out the issue and talked as stakeholders and were able to come to an agreement on an issue very quickly and the turnaround time was fantastic.”
Key Points:
Main Takeaway: Flexibility and continuous support are crucial for a successful go-live and sustained performance. |
Final Thoughts:
The sponsor oversight and provider partnership approaches exemplified in this Veeva RTSM webinar underscore the importance of strategic planning, robust stakeholder engagement, standardized integration, and flexible UAT processes. By fostering a collaborative environment and providing continuous support, this model enhances not only effectiveness of systems and multi-study programs, but helps individuals and collectives become the best version of themselves.
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