This invitation-only conference offers networking opportunities, product showcases, insightful client success stories, and thought-provoking sessions featuring Trial Interactive experts and industry-leading 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.
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.
Meet the TI Team
Interested in seeing last year's panel discussions?
Watch our 2024 opTImize panel discussions.
Agenda
Agenda and timing of sessions are subject to change
TBD
The Future of TMF: AI-Driven Quality Assurance, Insights, and Automation – (Automate)
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 transforms 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.
TBD
Beyond the Checklist: Driving TMF Compliance Through Training and Engagement
Achieving TMF compliance is about both policies and people. In this session, we’ll explore how training and ongoing engagement strategies can transform TMF compliance from a top-down directive into a shared responsibility across cross-functional teams. Learn how to build a culture of TMF ownership through interactive learning, real-world role-based training, and practical tools from TMF University. Whether you’re onboarding new staff or re-engaging experienced teams, walk away with actionable ideas to make compliance stick.
TBD
Powering Site Partnerships Through Collaboration and Tech
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.
TBD
ICH E6(R3) and Industry Updates
With the release of ICH E6(R3), clinical trials are entering a new era of expectations around data integrity, quality by design, and risk-based approaches. This session will examine the key changes introduced in R3 and how they’re impacting sponsor responsibilities, technology use, and inspection readiness. Gillian will also provide an update on the development of version 4 of the TMF Reference Model, which is being revised to meet the needs of today’s digital landscape.
TBD
Sponsor Oversight Through the eTMF
In this keynote session, Laurel-Ann Schrader will explore how sponsors can leverage the eTMF as a strategic tool for oversight, inspection readiness, and compliance. She’ll outline regulatory expectations from global agencies, including the MHRA, EMA, and FDA. Drawing on her real-world experience leading the Trial Interactive client solutions team—where she supports inspection readiness and audit preparedness—Laurel-Ann will highlight how proactive eTMF management can help sponsors mitigate risk and maintain a state of audit-readiness every day.
TBD
TMF Management – View from the CROs
When sponsors rely on CROs to manage critical TMF activities, effective oversight and organizational alignment are essential. In this session, CRO leaders will share their perspectives on TMF management—highlighting strategies to meet sponsor expectations, maintain inspection readiness, and adapt to evolving regulatory requirements. The discussion will explore best practices for collaboration, the importance of clearly defined roles and responsibilities, and how CROs and sponsors can work together to reduce risk and elevate quality.
TBD
AI in Medical Writing – Content Creation in 2025
Generative AI is transforming the commercial landscape for life sciences organizations, enhancing everything from medical writing to multilingual content creation. This session will showcase real-world applications of AI across key functions, including medical communications, e-learning, digital content, product support, and pharmacovigilance. Through data-driven examples, we’ll demonstrate how AI is accelerating timelines, reducing costs, and improving engagement—such as a 50% reduction in scientific publication QA time and a 45% increase in training engagement. Whether you’re developing global campaigns or managing complex product information, discover how AI is delivering measurable value across the life sciences space—and what steps your organization can take next.
TBD
Inspection Readiness Prep: From GCP Corrections to Quality Issue Management
Study reconstruction is often seen as a last-resort effort, but it’s a vital part of ensuring GCP compliance and inspection readiness. This session will clarify what study reconstruction truly involves and how it can be approached strategically. Experts from Trial Interactive’s TMF Services team will walk through each component, including how to identify missing or non-compliant documentation, issue GCP corrections, log quality issues appropriately, and align with audit expectations. Learn how proactive TMF oversight and a structured reconstruction process can not only salvage a trial, but also strengthen your organization’s long-term quality management systems.
TBD
Breaking Down Silos: Cross-Functional Collaboration for TMF Success
Achieving TMF excellence requires seamless 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.
TBD
Migrate with Confidence – Technical Migration and Archival Strategies for Completeness
Take the difficulty out of migrations with careful planning, technical expertise, and a clear understanding of regulatory expectations. This session will focus on the technical aspects of TMF migration, including metadata mapping, document integrity checks, system compatibility, and audit trail preservation. Attendees will learn best practices for executing a smooth, validated migration that ensures completeness, accuracy, and ongoing compliance with GCP. Whether you’re preparing for a system upgrade, transitioning vendors, or centralizing legacy data, this session will help you do it right—the first time.
8:30 - 9:00 AM
1:1 Meetings and Registration
Kick off day 2 of OpTImize with personalized insights. Take advantage of complimentary 1:1 meeting with experts from Trial Interactive and LMK.
Book a slot and get advice tailored to your unique challenges by reaching out to optimize@transperfect.com.
9:00 - 9:30 AM
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.

Jay leads the development of product features and new capabilities for Trial Interactive, bringing over 25 years of experience in product management, consulting, and engineering across life sciences, enterprise software, healthcare, and other industries. Before TransPerfect, he oversaw cloud migrations for enterprise platforms at Medidata and Sparta Systems. His expertise spans eTMF, CTMS, RTSM, EDC, Coding, Grants, and eCTD solutions, as well as enterprise quality and document management. Jay has also developed mobile apps for physicians, sales reps, and consumers in music and sports. His leadership drives innovation in clinical and regulatory technology.
9:30 - 10:30 AM
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.

Katherine Cianciarelli is a senior product manager with almost a decade of experience in eClinical technology. An engineer by trade, she focuses on building practical AI tools that improve clinical research workflows. Her work centers on finding smart ways to optimize processes while ensuring responsible and compliant technology use, always seeking to bridge the gap between technical innovation and real-world research needs.

Jay leads the development of product features and new capabilities for Trial Interactive, bringing over 25 years of experience in product management, consulting, and engineering across life sciences, enterprise software, healthcare, and other industries. Before TransPerfect, he oversaw cloud migrations for enterprise platforms at Medidata and Sparta Systems. His expertise spans eTMF, CTMS, RTSM, EDC, Coding, Grants, and eCTD solutions, as well as enterprise quality and document management. Jay has also developed mobile apps for physicians, sales reps, and consumers in music and sports. His leadership drives innovation in clinical and regulatory technology.


10:30 - 10:45 AM
Break
10:45 - 11:30 AM
CTMS and eTMF Interoperability: Achieving a Unified Digital Ecosystem
In today’s clinical trials, interoperability between your CTMS and eTMF is a 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.

Michael Smyth has 30+ years of experience working in the pharmaceutical clinical development industry across sponsors and CROs. Michael, fueled by, his passion consults with our pharmaceutical, biotechnology, medical device, and CRO clients to determine how to most efficiently use our Trial Interactive platform to streamline clinical development processes for all stakeholders. Smyth is an active member of the Drug Information Association and frequent blogger on all things focused on improving the entire clinical trial landscape to bring products to market faster.

Hope formally joined TransPerfect in 2021 after nearly two years of working as a contractor with TransPerfect’s Trial Interactive (TI) team developing our Clinical Trial Management System (CTMS). Hope brings 16 years of life science experience, including a vast knowledge of CTMS-related information and systems utilized across the industry in pharmaceutical and clinical research organizations. Trial Interactive officially launched its CTMS at the end of 2021 under Hope’s direction as the Product Owner. Since the launch, TI’s CTMS solution has continued to incorporate over 50% of customer-requested improvements within each release.

April Mattison-Wolfe brings 24 years of Clinical Operations experience to TransPerfect’s Trial Interactive (TI) Technical Services, including 7+ years as a Clinical Operations Trainer and Clinical Business Systems Analyst. With expertise from both sponsors and CROs, she helps TI clients identify CTMS needs and configure tailored solutions. April’s deep understanding of clinical systems requirements and pharmaceutical business practices ensures clients optimize their clinical trial management systems for efficiency and compliance.

Katherine Cianciarelli is a senior product manager with almost a decade of experience in eClinical technology. An engineer by trade, she focuses on building practical AI tools that improve clinical research workflows. Her work centers on finding smart ways to optimize processes while ensuring responsible and compliant technology use, always seeking to bridge the gap between technical innovation and real-world research needs.

Senior CRA experienced in working in CRO, CRU, Sponsor, FSP/Sponsor Dedicated, Full-Service models, Rx/Ax and Phase 1/Early Development studies with background as a Study Coordinator/site staff, Site Monitor, Oversight CRA, Lead CRA, CTMS SME/Implementation team member, Inspection Readiness team member, and Global Clinical Lead.
11:30 AM - 12:00 PM
CRO Oversight and 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.

Gillian Gittens, Director of eClinical Strategy and Solutions, is a TMF industry veteran with over 25 years’ experience. Gill has a wealth of insight and expertise in managing TMF services and delivering ongoing customer success across all aspects of TMF operations. A member of the CDISC TMF Reference Model Steering Committee and Project Management Team leading the V4 initiative, Gill has key expertise and insight in industry best practice, regulatory guidance and the future of TMF management.

Laurie came to TransPerfect 3 years ago from the CRO space, working the previous 14 years at Worldwide Clinical Trials in the TMF Mgmt. group and has experience with several eTMF systems (which included TI as the CRO’s System Admin). Laurie worked on over 500 studies across all therapeutic areas and phases I-IV, pre- and post-marketing, First in Human, and Post-Marketing/Evidence studies. She strongly values the relationship between functions and systems and ensuring everyone is following the quality requirements and best practices to ensure delivery of inspection ready TMFs and positive audit/inspection results. Quality is everyone’s responsibility.


Dedicated and driven professional with over 18 years of experience, including 11+ years leading strategy and oversight in TMF, records management, and study start-up. Proven track record in ensuring quality and compliance, enhancing TMF operational efficiency, and driving successful project outcomes. Passionate about creating collaborative work environments and fostering teamwork to support advancements in clinical research and contribute to the development of innovative healthcare solutions.

Angela Moore is a clinical research leader with over 20 years of experience managing global Phase I–IV trials across multiple therapeutic areas, including oncology, dermatology, and rare diseases. As Director of Clinical Operations at Bausch Health, she leads the Post-Market Research team, driving vendor oversight and study execution. With leadership experience across sites, CROs, and sponsors, Angela brings a comprehensive view to trial operations. A PMP-certified professional with a Master of Health Leadership, she is passionate about TMF oversight, study start-up, and process automation to improve efficiency and compliance in clinical research.
12:00 - 1:00 PM
Networking Lunch
1:00-2:00pm
Powering Site Partnerships Through Collaboration and Tech
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.

With nearly 30 years in life sciences, Chris is a strategic leader dedicated to solving challenges, optimizing processes, and driving innovation. Her experience spans CROs, sponsors, academia, non-profits, and technology vendors, giving her a unique perspective on industry needs. At TransPerfect, she develops and implements innovative solutions that deliver real impact. Chris is committed to turning ideas into results, consistently exceeding expectations through her expertise in quality, business strategy, and technology. Her dedication to continuous improvement ensures clients stay ahead in an evolving industry.




2:00 - 2:45 PM
Mastering TMF Migrations, Archiving & 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.

Gillian Gittens, Director of eClinical Strategy and Solutions, is a TMF industry veteran with over 25 years’ experience. Gill has a wealth of insight and expertise in managing TMF services and delivering ongoing customer success across all aspects of TMF operations. A member of the CDISC TMF Reference Model Steering Committee and Project Management Team leading the V4 initiative, Gill has key expertise and insight in industry best practice, regulatory guidance and the future of TMF management.




2:45 - 3:00 PM
Conference Wrap Up

Michael Smyth has 30+ years of experience working in the pharmaceutical clinical development industry across sponsors and CROs. Michael, fueled by, his passion consults with our pharmaceutical, biotechnology, medical device, and CRO clients to determine how to most efficiently use our Trial Interactive platform to streamline clinical development processes for all stakeholders. Smyth is an active member of the Drug Information Association and frequent blogger on all things focused on improving the entire clinical trial landscape to bring products to market faster.
3:00 - 5:00 PM
1:1 Meetings
Book a slot and get advice tailored to your unique challenges by reaching out to optimize@transperfect.com.
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 for more than just TransPerfect and Trial Interactive clients! The summit is geared toward executives, directors, and senior managers within the clinical trial industry. Spaces are limited and will be prioritized accordingly, therefore eligibility is subject to approval by the TransPerfect Trial Interactive team.
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.