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Trial Interactive Customer Summit

Sheraton Commander Hotel
16 Garden Street
Cambridge, MA 02138
June 3-4th, 2025
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Join us this June in Boston for OpTImize, the 2nd annual Trial Interactive customer summit. This invitation-only conference offers networking opportunities, product showcases, insightful client success stories, and thought-provoking sessions featuring Trial Interactive experts and guest speakers.  

Designed with the Trial Interactive user in mind, the agenda includes opportunities to interface with our experts and ask your most burning questions. Come interact with your peers and help drive the evolution of Trial Interactive. 

Sessions will include: 

  • Intensive TMF sessions: Engage with TMF experts and participate in workshops to stay inspection ready. Effectively free, in-depth TMF consulting! 
  • Maximizing Trial Interactive: Get tips, tricks, and strategies to enhance your platform experience. 
  • Real-Time Compliance: Receive advice from our experts on how to stay ahead of the curve 
  • Clin Ops Innovation: Explore future trends in clinical operations and how you can drive efficiency and success. 

Don’t miss out on the chance to attend the OpTImize Summit. Secure your spot and be part of shaping the future of your eClinical solutions. 

Day 1: Optimizing Clinical Operations with AI, Automation, and Best Practices

Subject to change

9:00-10:30am: 1:1 Meetings and Registration

Networking and strategic discussions with key industry leaders.

10:30-11:00am: Official Kickoff and Jeopardy

Join us as we kick off the summit with an interactive, industry-themed Jeopardy to engage attendees and set the stage for insights.

11:00-11:30am: Regulatory Disruption: Navigating TMF Reference Model V4 + ICH E6 (R3) Compliance

Explore the evolving regulatory landscape and its impact on TMF management. This session will break down the key updates in TMF Reference Model V4 and ICH E6 R3, providing critical insights into how these changes influence compliance expectations, documentation practices, and inspection readiness. Learn what these shifts mean for your organization, what steps you should take now to stay ahead, and how to future-proof your TMF strategy.

11:30-11:45am: Coffee Break

11:45-12:30pm: CRO Oversight & Vendor Collaboration: Achieving Inspection-Ready TMFs

Effective CRO oversight and vendor collaboration are critical to maintaining an inspection-ready TMF. This panel will explore how leading sponsors and CROs are leveraging strategic partnerships, governance models, and technology-driven solutions to enhance compliance, improve efficiency, and reduce risk. Gain insights into best practices for managing expectations, ensuring data integrity, and fostering seamless collaboration between sponsors and CROs to meet evolving regulatory requirements.

12:30-1:30pm: Breaking Down Silos: Cross-Functional Collaboration for TMF Success

Achieving TMF excellence requires collaboration across teams like Clinical, Regulatory, Data Management, and Quality. In this panel, industry experts will share insights on breaking down silos, fostering communication, and aligning cross-functional priorities to ensure TMF completeness, compliance, and inspection readiness. Learn practical strategies for improving teamwork, streamlining documentation processes, and leveraging technology to create a truly collaborative TMF environment.

1:30-2:30pm: Lunch and Networking

2:30-3:00pm: Education and Training: Sponsor Requirements for GCP Compliance

Explore the critical role of education and training in ensuring that sponsors meet Good Clinical Practice (GCP) requirements. Learn how organizations are implementing effective training programs, continuous learning strategies, and compliance best practices to empower teams, reduce risk, and improve overall TMF management. Walk away with actionable insights to strengthen your training initiatives and drive long-term regulatory compliance.

3:00-3:45pm: CTMS + eTMF Interoperability: Achieving a Unified Digital Ecosystem

In today’s clinical trials, interoperability between your CTMS and eTMF isa necessity. Tune in for a panel on how integrating these systems streamlines trial operations, enhances compliance, and improves overall efficiency. Learn how real-time data exchange, automation, and centralized oversight can reduce manual effort, minimize discrepancies, and ensure a more holistic approach to trial management. Gain insights into best practices, common challenges, and future trends driving the push for a truly unified digital ecosystem. 

3:45-4:00: Break

4:00-4:30pm: Rapid Fire eClinical Innovation Spotlight

Join Michael Smyth and Jay Smith for a fast-paced, insider look at the latest innovations transforming the eClinical landscape. This session will showcase cutting-edge advancements in AI-powered features across Trial Interactive’s suite of solutions, including GlobalLearn, TI CTMS, and new solutions like QMS. Discover how these innovations are enhancing automation, streamlining compliance, and driving efficiency across clinical trial operations.  

4:30-4:45pm: Closing Remarks

5:00-6:00pm: Networking Reception

Day 2: Best Practices, Innovation, and TMF Lifecycle Management

8:30-10:00am: 1:1 Meetings, Registration, and Breakfast

10:00-10:30am: The AI Evolution: What Should I Know?

Artificial Intelligence continues to show promise for impacts to the eClinical space—but what does it mean for clinical trials today? In this session, Jay Smith, Trial Interactive’s Head of Product will break down how AI-powered technology is being rolled out across the industry and what it means for data integrity, efficiencies in study management, and overall trial execution. Learn about real-world applications, key challenges, and future trends shaping AI adoption in clinical research. Whether you’re just starting to explore AI or looking to implement tomorrow, this session will provide a practical understanding of AI’s impact on clinical operations.

10:30-11:30am: The Future of TMF: AI Driven Quality Assurance, Insights, and Automation

Artificial Intelligence is fundamentally changing TMF management, introducing powerful tools for quality assurance, oversight, and compliance. This panel will dive into AI-powered TMF automation and how it’s transforming TMF processes. Learn how organizations are leveraging AI tools like Trial Interactive automate to identify risks, streamline document classification, and enhance real-time insights, ultimately driving greater efficiency and regulatory readiness.

11:30-11:45am: Coffee Break

11:45-12:30pm: End-to-End Inspection Readiness: Author to Archive

Explore real-world strategies for ensuring regulatory compliance from study start-up to long-term archiving.

12:30-1:00pm: Quality and Completeness Oversight: Events Manager and Quality Module

Join Avani Amin, Associate Director of Client Solutions, and Stacy Dagana, Implementation manager, for a hands-on workshop exploring how automation can transform TMF periodic reviews and document completeness oversight. This session will provide a deep dive into Trial Interactive’s Events Manager and Quality Module, showcasing how these tools streamline risk-based quality reviews, enhance compliance monitoring, and improve overall TMF health. Learn how to leverage automation to identify gaps, mitigate risks, and ensure real-time completeness tracking, ultimately reducing manual burden and strengthening your inspection readiness strategy. 

1:00-2:00pm: Lunch and Networking

2:00-3:00pm: Site Perspective

Gain firsthand insights from site representatives as they discuss strategies for overcoming common challenges in study start-up, ongoing trial management, and study close-out. Learn how sites navigate regulatory hurdles, streamline workflows, and enhance collaboration to drive trial success.

3:00-4:00pm: Mastering TMF Migrations, Archiving, and Ownership Transitions: Lessons from Real-World Case Studies

Successfully managing TMF migrations, sponsor acquisitions, and long-term archiving requires careful planning, execution, and governance. In this workshop, speakers will share real-world case studies on overcoming challenges in TMF transitions, ensuring data integrity, and maintaining regulatory compliance throughout the process. Learn best practices for seamless system migrations, ownership transfers, and archival strategies that safeguard critical trial documentation. Whether you’re gearing up for a migration, archiving a completed study, or preparing for a regulatory inspection, this session will provide actionable insights to help you navigate complex TMF transitions with confidence.

4:00-4:30pm: Closing Remarks and Key Takeaways from Michael Smyth

4:00-5:00pm: One-on-Ones’

FAQ

Is this event free?

Yes, there is no registration fee associated with this event. However, spots are limited.

Who is this event for?

OpTImize is geared toward TransPerfect and Trial Interactive clients.

Do I have to attend both days?

No, registration covers both days, but we understand some people can only attend one day of sessions.

I have more questions, who do I contact?

Email optimize@transperfect.com with any additional questions.

Do you have a hotel room block?

Yes. There is a room block available. When you register for the event, you will receive the link.