Trial Interactive Customer Summit
Sheraton Commander Hotel
16 Garden Street
Cambridge, MA 02138
June 3 – 4, 2025
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
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.
Ben Rogers, LMK’s Manager of TMF Education and Employee Development, is responsible for LMK’s TMF University, including the delivery of accredited TMF University courses and the thorough evaluation of student competency assessments. He also oversees LMK’s Corporate Training & Education Program where he leads the development of training content and resources for LMK staff and clients. He has extensive experience in the clinical research industry and has worked in nearly every facet of TMF, from Document Technician to Senior Manager of Site Management Services and TMF.
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.
Laurel-Ann Schrader is a resident TMF subject matter expert. She is a Certified TMF Manager with 21+ years’ experience. Her expertise includes TMF inspection readiness, preparation, and support; best practices for clinical document processes, procedures, and cross-functional culture; eTMF implementation and management; and the real-world application of the TMF Reference Model. She previously worked in clinical operations at Ardea Biosciences, ICON, BioPharm Systems, and Amylin Pharmaceuticals. Laurel is an active participant and contributor to the TMF Reference Model working groups and is a thought leader in the TMF industry.
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.
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.
With nearly 30 years in life sciences, Christine 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.
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.
Stacy Dagana has 10 years of experience in the pharmaceutical industry on the vendor side, starting in records management before transitioning to document processing, project management, and implementation. For the past 3.5 years at Trial Interactive, she has successfully implemented eTMF, SSU, eISF, MyTI, and eFeasibility for over 50 clients. Stacy specializes in helping customers navigate settings, features, and configurations for these platforms. She is also available for working sessions on valuable eTMF enhancements, including CRA reconciliation, required documents/events management, and quality review, ensuring clients maximize efficiency and compliance from the start.
Michael Smyth is the Division President of TransPerfect’s Life Science Solutions, including the Trial Interactive platform and its solutions. Smyth has 30+ years of experience working in the pharmaceutical clinical development industry across sponsors and CROs. Michael as 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.
Avani Amin brings 18 years of experience in TMF management and oversight, having worked across multiple FSP TMF providers. She leads the eClinical Solutions Study Owner unit at Trial Interactive, overseeing TMF management for 200+ clients. Avani specializes in best practices around system implementation, TMF oversight and customer success for our global customer base. She also provides expert TMF consulting, assisting clients with eTMF and CTMS optimization, business process development, and SOP/TMF plan creation. With evolving regulations and technology, Avani promotes compliance by effectively communicating regulatory expectations and TMF requirements across the clinical document and trial management space.
Interested in seeing last year's panel discussions?
Watch our 2024 opTImize panel discussions.
Speakers
Agenda
9:00 - 10:30 AM
1:1 Meetings and Registration
Begin your OpTImize experience 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.
10:30 - 11:00 AM
Event Kickoff
Join Trial Interactive Division President Michael Smyth, for the official kick off of the 2nd annual OpTImize Summit!
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.
11:00 - 11:30 AM
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.
Laurel-Ann Schrader is a resident TMF subject matter expert. She is a Certified TMF Manager with 21+ years’ experience. Her expertise includes TMF inspection readiness, preparation, and support; best practices for clinical document processes, procedures, and cross-functional culture; eTMF implementation and management; and the real-world application of the TMF Reference Model. She previously worked in clinical operations at Ardea Biosciences, ICON, BioPharm Systems, and Amylin Pharmaceuticals. Laurel is an active participant and contributor to the TMF Reference Model working groups and is a thought leader in the TMF industry.
Janice has over 15 years of experience in clinical research (pharmaceutical, biotech and CRO), providing direction and leadership in the clinical operations and document management areas. Her experience includes strategic planning and oversight of TMF services such as eTMF implementation, process development, business/technology alignment, TMF management, content migration, audit and regulatory inspection readiness, risk management, CAPA implementation, KPI/metrics development, line management, resource and budget planning, and cross-functional team leadership. Her results driven approach and continuous improvement mindset are proven for client’s success.
John Saviski is the Director, Clinical Documentation at GSK where he co-leads a team responsible for TMF framework. His team serves as Global Process Owner for TMF, building inspection readiness and driving TMF engagement and capability across the organization.
Before joining GSK, John held study management roles across small and large biotech companies and CROs. He has extensive experience as TMF point person, supporting multiple regulatory inspections and audits.
Amelie Rivet has over 12 years of experience in clinical research, with a strong background in project management and TMF operations.
She spent much of her career in various project management roles at Indero, a Canadian CRO specializing in dermatology and rheumatology (formerly Innovaderm Research). Over the past two years, she has focused on TMF activities, leading Indero’s TMF Operations group to ensure the compliance and efficiency of eTMFs. By implementing new strategies and processes, Amelie has significantly enhanced TMF quality and contributed to more data-driven eTMF management.
Rebecca Halbur is the Associate Director of TMF Operations at Moderna, where she leads a team focused on TMF strategy, health, and inspection readiness. With over 15 years of TMF experience and system expertise in Veeva Vault, IQVIA TMF, and Trial Interactive, she brings a strategic lens to process optimization and innovation. She holds a B.S. in Biology and a Master of Liberal Arts in Sustainability from Harvard Extension School and previously served on the board of directors for the nonprofit – Water for Good.
11:30 - 11:45 AM
Break
11:45 AM - 12:15 PM
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.
Ben Rogers, LMK’s Manager of TMF Education and Employee Development, is responsible for LMK’s TMF University, including the delivery of accredited TMF University courses and the thorough evaluation of student competency assessments. He also oversees LMK’s Corporate Training & Education Program where he leads the development of training content and resources for LMK staff and clients. He has extensive experience in the clinical research industry and has worked in nearly every facet of TMF, from Document Technician to Senior Manager of Site Management Services and TMF.
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.
Founded SWAT Research Services in 2001 as a provider of boutique contract clinical research services. In the past decade we have specialized in assisting struggling biotech and small pharma companies with study rescue and turnaround.
Tara Cruz is a Clinical Project Manager at Satsuma Pharmaceuticals with four years of experience supporting GCP compliance through Trial Master File (TMF) management, study start-up, and clinical operations. She contributed to Satsuma’s first NDA approval and brings a strong understanding of sponsor obligations under GCP. Tara began her career at the site level, where she supported sponsor audits and an FDA for-cause inspection—an experience that sparked her passion for GCP training and inspection readiness. She brings a sponsor-focused lens to documentation, oversight, and collaborative compliance efforts.
Jodi Scarola leads Takeda’s GCP Excellence in Clinical Trials team, focusing on embedding inspection readiness and TMF quality in study operations. With over 20 years of experience, Jodi has worked at site, CRO, and sponsor levels, gaining broad industry expertise. She is skilled at supporting organizations through inspections, acquisitions, and change management. Jodi is dedicated to using analytics and innovation to improve processes and enhance oversight of the TMF. She values collaboration and prioritizes quality documentation, helping teams continuously improve compliance and drive inspection readiness.
12:15 - 1:00 PM
Risk Based Quality Review + 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.
Avani Amin brings 18 years of experience in TMF management and oversight, having worked across multiple FSP TMF providers. She leads the eClinical Solutions Study Owner unit at Trial Interactive, overseeing TMF management for 200+ clients. Avani specializes in best practices around system implementation, TMF oversight and customer success for our global customer base. She also provides expert TMF consulting, assisting clients with eTMF and CTMS optimization, business process development, and SOP/TMF plan creation. With evolving regulations and technology, Avani promotes compliance by effectively communicating regulatory expectations and TMF requirements across the clinical document and trial management space.
Stacy Dagana has 10 years of experience in the pharmaceutical industry on the vendor side, starting in records management before transitioning to document processing, project management, and implementation. For the past 3.5 years at Trial Interactive, she has successfully implemented eTMF, SSU, eISF, MyTI, and eFeasibility for over 50 clients. Stacy specializes in helping customers navigate settings, features, and configurations for these platforms. She is also available for working sessions on valuable eTMF enhancements, including CRA reconciliation, required documents/events management, and quality review, ensuring clients maximize efficiency and compliance from the start.
1:00 - 2:00 PM
Networking Lunch
2:00 - 3:00 PM
End-to-End Inspection Readiness: Author to Archive
Explore real-world strategies for ensuring regulatory compliance from study start-up to long-term archiving.
Laurel-Ann Schrader is a resident TMF subject matter expert. She is a Certified TMF Manager with 21+ years’ experience. Her expertise includes TMF inspection readiness, preparation, and support; best practices for clinical document processes, procedures, and cross-functional culture; eTMF implementation and management; and the real-world application of the TMF Reference Model. She previously worked in clinical operations at Ardea Biosciences, ICON, BioPharm Systems, and Amylin Pharmaceuticals. Laurel is an active participant and contributor to the TMF Reference Model working groups and is a thought leader in the TMF industry.
Jessica Jackson is Head of Clinical Operations at Galderma Laboratories with 30 years in the pharmaceutical industry; leading multidisciplinary-matrix project teams, driving portfolio development plans, and supporting resource strategies. Jessica is driven to accelerate the clinical development process by designing and implementing innovative, adaptive platforms, identifying programmatic challenges and opportunities and developing result-driven operational strategies.
I’ve been in the pharmaceutical research space for almost 20 years, with a core focus in Study Start-Up and TMF Remediation. My favorite thing to do is find ways to ‘work smarter, not harder’ and the innovations we have with Trial Interactive as our partner has helped us along the way!
David lives for operational excellence in systems, process, and information management strategies and has a knack for wrangling even the unruliest TMF challenges. He is fluent in GxP and sometimes dreams in metadata.
Brandy Ward holds a master’s degree in medical laboratory science and brings over 20 years of experience in the pharmaceutical, manufacturing, and CRO sectors. She is a TMF subject matter expert with core strengths in communication, planning, change management, controlled documents, training, and program improvement. Based in Raleigh, NC, Brandy shares her home with her husband, cats, and a 30-year-old parrot. Outside of work, she enjoys upcycling crafts and volunteers at the Carolina Tiger Rescue.
3:00 - 3:45 PM
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.
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.
Lisa Mulcahy has an extensive career in the biopharmaceutical industry in the areas of Clinical Operations, Quality Management, and TMF Management. She is an independent consultant for the last 17 years who ties previous work experiences together to assist clients to develop, revise, and operationalize high-quality and compliant electronic TMF management processes and systems to achieve complete and inspection-ready of TMFs and their long-term preservation. Lisa is a co-founder and a current Steering Committee member of the CDISC TMF Reference Model volunteer team of industry representatives that created and maintain the model. Lisa is a member of the Project Management team leading the update of the TMF RM to V4.
3:45 -4:00 PM
Break
4:00 - 4:30 PM
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.
Michael Smyth is the Division President of TransPerfect’s Life Science Solutions, including the Trial Interactive platform and its solutions. Smyth has 30+ years of experience working in the pharmaceutical clinical development industry across sponsors and CROs. Michael as 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.
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.
4:30 - 5:30 PM
Networking Cocktail Reception
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.
Amelie Rivet has over 12 years of experience in clinical research, with a strong background in project management and TMF operations.
She spent much of her career in various project management roles at Indero, a Canadian CRO specializing in dermatology and rheumatology (formerly Innovaderm Research). Over the past two years, she has focused on TMF activities, leading Indero’s TMF Operations group to ensure the compliance and efficiency of eTMFs. By implementing new strategies and processes, Amelie has significantly enhanced TMF quality and contributed to more data-driven eTMF management.
Nick Hargaden is Director, Clinical Trial Systems and Operations at Moderna and a member of the CDISC TMF Steering Committee. His current responsibilities at Moderna include business owner for eTMF and CTMS applications, and global head of TMF Operations managing in house and vendor teams. He has worked in the application of software technology in clinical trial operations since 1998, encompassing IRT, TMF, RBQM, eCOA and more. He has held leadership positions with global responsibilities in operational, business development, and quality management functions. He cofounded, built, and sold a data analytics software company in the RBQM space.
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.
Jessica Jackson is Head of Clinical Operations at Galderma Laboratories with 30 years in the pharmaceutical industry; leading multidisciplinary-matrix project teams, driving portfolio development plans, and supporting resource strategies. Jessica is driven to accelerate the clinical development process by designing and implementing innovative, adaptive platforms, identifying programmatic challenges and opportunities and developing result-driven operational strategies.
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.
Latina Clinical Research Advocate, Mentor, and site owner with 20 years of experience and 17 years leading a research site in a small, rural, underserved Latino border community. Co-founder of Latinos in Clinical Research and Save Our Sites. Committed to improving the clinical research industry, supporting site sustainability, and mentoring others while ensuring diverse and underserved communities have access to and understanding of clinical trials.
Monica Cuitiva is a dedicated Latina professional committed to building a more inclusive and sustainable future in clinical research. She is the Co-Founder of Clarity Clinical Research, Save Our Sites Conference, Latinos in Clinical Research, and The University of Clinical Research. Each founded in response to address critical gaps and unmet needs across the industry. Centered on collaboration, equity, community, and real-world solutions, Monica’s work strengthens research sites, amplifies underrepresented voices, and opens doors for those seeking to enter and thrive in the field.
Brad Hightower is a clinical research professional based in Oklahoma City, OK. With over ten years of experience at the site level, he formerly served as the Executive Director of the Oklahoma Heart Hospital Research Foundation. Brad now runs his own integrated site network, Hightower Clinical, is a Co-Founder of Save Our Sites (SOS) and hosts a popular industry podcast.
LaShoun Sanders is the Founder and Executive Director of iHealthClinical, a growing physician-embedded clinical research network focused on expanding access, equity, and innovation in clinical trials. With over 20 years of experience in clinical operations, workforce development, and community engagement, LaShoun is a leading voice in building inclusive research ecosystems and high-performing site networks. Her work bridges the gap between clinical care and research, driving faster enrollment, regulatory excellence, and greater representation of underserved communities in science.
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.
John Saviski is the Director, Clinical Documentation at GSK where he co-leads a team responsible for TMF framework. His team serves as Global Process Owner for TMF, building inspection readiness and driving TMF engagement and capability across the organization.
Before joining GSK, John held study management roles across small and large biotech companies and CROs. He has extensive experience as TMF point person, supporting multiple regulatory inspections and audits.
Amelie Rivet has over 12 years of experience in clinical research, with a strong background in project management and TMF operations.
Founded SWAT Research Services in 2001 as a provider of boutique contract clinical research services. In the past decade we have specialized in assisting struggling biotech and small pharma companies with study rescue and turnaround.
Ashley O’Bannon is a Manager within Premier Research Global Records Management, with over eight years at the company. Based in Sanford, NC, she specializes in eTMF efficiency, management, and process improvement. Ashley is passionate about collaboration and information sharing with fellow eTMF professionals.
Alicia Contreras is a seasoned Clinical Research Professional with 12 years of experience in the clinical research industry, including the pharmaceutical sector and clinical site management. She has a strong background in conducting clinical trials in compliance with GCP, ICH, HIPAA, and FDA regulations, ensuring the collection of high-quality data for sponsors.
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.
Is there a hotel room block?
Yes. There is a room block available. When you register for the event, you will receive the link.
