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Trial Interactive Customer Summit

Join us for the inaugural OpTImize Summit, the first Trial Interactive customer event brought to you in partnership with GlobalLink NEXT. This invitation-only conference offers networking opportunities, product showcases, insightful client success stories, and thought-provoking sessions featuring Trial Interactive experts and guest speakers.

June 25-26, 2024

Sheraton Times Square
811 7th Avenue New York, NY 10019

Complete the form to reserve your spot:

This year’s summit has been designed with the Trial Interactive user in mind. The agenda includes opportunities to interface with our experts and ask your burning questions, as well as interact with your peers and help drive the evolution of Trial Interactive.

Day 1: Agenda

11:00-12:30pm: Check-in and Lunch

12:30-12:45pm: Opening Remarks

Michael Smyth
Division President
TransPerfect

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.

12:45-1:30pm: Establishing a Culture of Inspection Readiness

Learn about best practices when establishing a TMF team and how fostering a culture of inspection readiness can reduce risk. Our speakers will cover the various topics related to eTMF & TMF technology, highlighting important considerations for putting together your TMF team, best practices around TMF training, and other ways to increase collaborative efficiency.

MODERATOR

Laurel-Ann Schrader
Director, Client Solutions
TransPerfect

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.

Karry Calderon
Senior Manager, Clinical Systems & TMF Operations
Axsome Therapeutics

Karry Calderon is the Senior Manager of Clinical Systems & TMF Operations at Axsome Therapeutics, a biopharmaceutical company developing novel therapies for Central Nervous System (CNS) conditions that have limited treatment options. Karry is responsible for the administration of electronic systems used to support clinical trial operations such as the Clinical Trial Management System (CTMS), Study Start-Up (SSU) and electronic Trial Master Files (eTMFs).Alongside Clinical Systems, Karry manages TMF Operations and oversees a team of TMF Specialists. Her TMF Management experience includes eTMF system implementation and migrations, TMF process improvement and alignment with the TMF Reference Model, TMF quality oversight, cross-functional and CRO/System Vendor & Sponsor collaboration and is the main point of contact for TMF audits and inspections. Prior to her current role, she worked at the NYU Langone Health, Cardiovascular Clinical Research Center.

Monika Bas
Head of TMF Delivery
TFS

Monika is an entrepreneurial, quality focused Senior Director with over 20 years of global experience in the CRO industry. She has held a number of senior leadership positions in Clinical Operations, Project Management and Vendor Management, with the majority of her experience in international projects. Monika is a Doctor of Veterinary Medicine, specializing in veterinary surgery. She is a graduate of the Warsaw University of Life Sciences, where she worked as an academic lecturer. Monika is passionate about driving improvement, growth, process adaptation, technology implementation and development throughout the organization. In addition to daily work on high standard TMF oversight and delivery, she strives to build high performing teams.

Jessica Jackson
Head of Clinical Operations 
Galderma

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.

1:30-2:15pm: Inspection War Stories: Tales from the Frontline of Regulatory Inspections

Hear first-hand from seasoned professionals who have navigated numerous GCP inspections. Our experts will share their invaluable insights and lessons learned on the frontlines, including practical strategies and tips to enhance inspection readiness of the TMF. Join us for an engaging journey through the nuances of GCP inspections, equipping you with the knowledge to turn potential obstacles into opportunities for regulatory compliance success.

MODERATOR

Avani Amin
Associate Director, Client Solutions
TransPerfect

Avani Amin transitioned to Trial Interactive in 2018 following a decade-long tenure at an eTMF vendor. Initially a key member of the Project Management team for four years, Avani advanced to the role of Executive Project Manager. In this capacity, she oversaw system implementation, provided best practice guidance, and ensured ongoing customer success for TI’s premier clients. With over 15 years in the clinical industry, Avani has now shifted into TMF consulting. Leveraging her expertise, she assists clients with industry best practices, optimization of eTMF and CTMS systems, business process development, and SOP/TMF plan creation. Avani’s dedication drives value for our clients.

Jamie Toth
Sr. Director, TMF Management & Records
BeiGene

Jamie Toth is Global Head, Trial Master File Management & Records at BeiGene. Jamie is a CDISC Standards Committee and TMF Reference Model Steering Committee member, Chair of the Operations Committee, Director for the HSRAA, and a board member of AGxPE. She has led industry workstreams for TMF/eTMF and kicked off the ISF Reference Model initiative. Jamie is a CPM, a Six Sigma Green Belt, and is PROSCI certified. She has a master’s in clinical research & organizational management and a bachelor’s in business and technology. She enjoys family time, boating, swimming, fishing, and attending professional football games—go Giants!

Diane Chisholm
Head of Clinical Operations
Owkin

Diane is a highly experienced clinical research professional who has seen the TMF develop many times over the span of her career. She is also experienced with FDA, EMEA and MHRA Inspections

Tracy D. Read
Principal Clinical Trial Administrator 
Galderma Research and Development

Tracy is an experienced Principal Clinical Trial Administrator with a demonstrated history of working in Phase 2-IV clinical trials in pharmaceutical, consumer health and aesthetic industries. Skilled in clinical operations, vendor oversight management, project management, and budgeting of clinical studies globally.

Jackie Morrill
Executive Director
LMK Clinical Research Consulting

Jackie is a Lean Six Sigma Green Belt certified clinical research professional with 17 years of experience in clinical trial coordination and process improvement within the healthcare, biotech, and pharmaceutical industries. Since 2013, her dedicated focus has been on all things Trial Master File (TMF). Her experience includes oversight of electronic TMF (eTMF) implementations, coordination of large migration and QC projects, development of robust TMF metrics programs, overhaul of TMF processes, extensive inspection readiness preparation for FDA, MHRA, and PDMA inspections, and the creation of LMK’s accredited TMF University program.

2:15-2:30pm: Coffee Break

2:30-3:15pm: Innovation Spotlight: Novel Use Cases from TI Power Users

Experience groundbreaking applications and creative problem-solving by some of our most advanced users. Discover how these pioneers are leveraging Trial Interactive’s features in unique ways to drive efficiency, enhance compliance, and unlock new possibilities in clinical trial management. Gain insights into how you can apply these innovative practices to your own projects and push the boundaries of what’s possible with Trial Interactive.

MODERATOR

Michael Smyth
Division President
TransPerfect

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.

Penelope Manasco
CEO
MANA RBM

Penelope K. Manasco, M.D.’s entire career has been spent in clinical research at the National Institutes of Health, GlaxoSmithKline, and in executive leadership roles in clinical research software companies. Her current company, MANA RBM, recently launched the Site First Network Optimization Stack to enhance clinical site operations, quality, and efficiency.

Elaine Palmer
Director of Clinical Operations
Pivotal Research Solutions

Elaine Palmer has over 20 years of experience in the medical industry as an ICU/trauma nurse and over 15 years of experience in clinical research as a study coordinator, TMF specialist, CRA, CTM, PM, and site director. She is currently focused on creating an alliance of sites with a mission to bridge the gap between clinical trials and the diverse patient population.

Manishkumar Patel
Medical Science Systems Manager, R&D
Reckitt

Manish is a dynamic Clinical Systems Manager with 15 years of experience in Clinical Research. He is a pharmacist armed with a master’s degree in Pharmaceutical Science, he excels in optimizing clinical systems and ensuring compliance. His leadership has streamlined workflows, led staff training, and spearheaded system enhancements for improved patient care and operational efficiency. Passionate about innovation, he stays at the forefront of emerging technologies and regulatory requirements, ensuring excellence in clinical informatics. Committed to continuous improvement, Manish leverages cutting-edge solutions to empower clinicians and enhance healthcare outcomes.

3:15-4:00pm: OpTImize with Trial Interactive: Tips and Tricks to get the most out of your Trial Interactive experience

Designed to elevate your proficiency and maximize your platform use, this session will offer insider knowledge from advanced features to efficiency-boosting shortcuts, directly from the minds behind Trial Interactive. Whether you’re a new user seeking to get a solid start or a seasoned pro looking to optimize your workflows, our expert-led presentation will give you strategies to enhance your project management and operational outcomes.

MODERATOR

Christine Morris
Executive Director 
TransPerfect

Throughout her nearly 30-year career, Chris has emerged as a prominent strategist in life science solutions. Her drive stems from a deep-seated passion for overcoming challenges, refining business processes, and fostering technological growth. With valuable insights gained from contributions to contract research organizations, sponsors, academic institutions, non-profit entities, and technology vendors, her diverse experience provides a unique perspective. This enables her to develop, support, and implement innovative for TransPerfect’s clientele. Committed to translating concepts into tangible outcomes, Chris consistently exceeds expectations by leveraging her quality mindset, business and technology acumen, and dedication to continuous improvement.

Stacy Collins
Senior Director, Operational Delivery
Bionical Emas

Stacy has been in the CRO space for 18 years and believes study start-up should be the kick-off to a quality TMF. She enjoys learning new technologies and ways to make study life easier for sites and colleagues.

Jeff Coffield
Regulatory Specialist
Reynolds American Services

Jeff has worked in the tobacco documentation industry for 26 years and has been employed by Reynolds American Services for 7 years as a Regulatory Specialist. He manages the eTMF and assists with applications submitted to Center for Tobacco Products. He is a certified TMF Manager through LMK’s TMF University.

Suzanne Turner
Owner/TMF Consultant
ICE Consulting LLC / Spero Therapeutics

Suzanne Turner is a Trial Master File Subject Matter Expert supporting sponsors with TMF management, process development, and compliance. She brings over 11 years of TMF management experience across CRO, sponsor, and consulting sectors, and is a CDISC TMF volunteer. Establishing ICE Consulting in 2023 allowed Suzanne to focus on direct collaboration with sponsors, particularly smaller companies, tailoring solutions to their unique needs to ensure inspection readiness.

Sara Adams
Clinical Research Associate
Supernus Pharmaceuticals

Sara Adams has been a Clinical Research Associate with Supernus Pharmaceuticals and has been working closely with Trial Interactive since she started in 2021. She is knowledgeable about the LMS, eISF, and has dabbled in the eTMF system. Sara is always looking for easier ways for the LMS system to communicate with not only the Sponsor but the sites as well.

Lori Braun
TMF Specialist
Avacta

Lori Braun specializes in overseeing TMF projects, emphasizing process establishment, improvement, and new electronic TMF system implementation. With expertise in TMF study management, she ensures document quality, timeliness, and completeness. Proficient in document processing and quality checks, Lori is recognized for meticulous TMF quality review, observation capture, and findings reconciliation facilitation. Additionally, she adeptly serves as an eTMF Business Administrator, managing user permissions and actively participating in User Acceptance Testing (UAT) for seamless operation. Since 2021, Lori has excelled as a TI System Business Administrator, contributing her skills to optimize system functionality.

4:00-4:45pm: Next Generation Innovation: The Future of eClinical Technology

Explore the future of clinical research in this session dedicated to the latest in eClinical technologies. Join our experts as they examine technological innovations, TMF Reference Model updates, and crucial regulatory updates including ICH E6 R3 and M11. Attendees will gain pragmatic insights into upcoming trends, industry insights, and regulatory impacts.

4:45-5:15pm: eClinical Problem Solving: Question and Answer with TI Experts

Explore the future of clinical research in this session dedicated to the latest in eClinical technologies. Join our experts as they examine technological innovations, TMF Reference Model updates, and crucial regulatory updates including ICH E6 R3 and M11. Attendees will gain pragmatic insights into upcoming trends, industry insights, and regulatory impacts.

Jay Smith
Senior Director, Product Management
TransPerfect

Jay Smith is responsible for managing the creation and design of product features and new capabilities for Trial Interactive. He brings over 25 years of product management, consulting, and engineering experience across verticals such as life sciences, enterprise software, healthcare, government, entertainment, and manufacturing. Prior to TransPerfect, Jay directed teams on moving several enterprise product platforms to the cloud at Medidata and Sparta Systems. He has supervised the management of a clinical portal, eTMF, CTMS, RTSM, EDC, Coding, and Grants solutions. Jay has also created and managed products for eCTD submission publishing and review, enterprise quality management, document management, computer validation, as well as mobile apps for physicians, sales reps, and music and sports fans.

Avani Amin
Associate Director, Client Solutions
TransPerfect

Avani Amin transitioned to Trial Interactive in 2018 following a decade-long tenure at an eTMF vendor. Initially a key member of the Project Management team for four years, Avani advanced to the role of Executive Project Manager. In this capacity, she oversaw system implementation, provided best practice guidance, and ensured ongoing customer success for TI’s premier clients. With over 15 years in the clinical industry, Avani has now shifted into TMF consulting. Leveraging her expertise, she assists clients with industry best practices, optimization of eTMF and CTMS systems, business process development, and SOP/TMF plan creation. Avani’s dedication drives value for our clients.

Lisa Gordon
Director of Professional Services
TransPerfect

Lisa joined the pharmaceutical industry in 2001 and moved to clinical in 2006. Lisa supported many clinical trials in a variety of therapeutic areas while working at CROs. In 2009, Lisa moved to the vendor side of clinical research and has supported multiple global pharmaceutical companies implementing eTMF and supported ongoing services. Lisa now leads the professional services team with a heavy focus on document services and supporting clients with her experiences, such as inspection readiness, TMF QC, document destruction, and archiving, to name a few.  Lisa is based out of our London office.

Laurel-Ann Schrader
Director, Client Solutions
TransPerfect

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.

Gillian Gittens
Director, eClinical Strategy and Solutions
TransPerfect

Gillian Gittens is the Director of eClinical Strategy and Solutions with TransPerfect Life Sciences, Gill leads our global eClinical consulting group. With over 25 years of experience as a Trial Master File (TMF) SME, she also has significant knowledge of strategic account management, operations, marketing, and business development. She is a current member of the CDISC Advisory Council and CDISC TMF Reference Model Steering Committee. Gill has been involved in many Reference Model initiatives over the past 2 decades

5:15-5:30pm: Closing Remarks

6:00-6:45pm: Networking Reception

Day 2: Agenda

9:00-10:00am: Breakfast

10:00-12:00pm: Meetings and Demos

11:30-12:30pm: Check-in and Lunch

12:45-1:30pm: Evaluating Your TMF Risk Workshop

In this workshop, our TMF experts will look for real-life examples to illustrate how you can establish a comprehensive risk plan for your TMF. Learn what to look for, where risk can hide, and how to gauge overall TMF health. 

Gillian Gittens
Director, eClinical Strategy and Solutions
TransPerfect

Gillian Gittens is the Director of eClinical Strategy and Solutions with TransPerfect Life Sciences, Gill leads our global eClinical consulting group. With over 25 years of experience as a Trial Master File (TMF) SME, she also has significant knowledge of strategic account management, operations, marketing, and business development. She is a current member of the CDISC Advisory Council and CDISC TMF Reference Model Steering Committee. Gill has been involved in many Reference Model initiatives over the past 2 decades.

Jackie Morrill
Executive Director
LMK Clinical Research Consulting

Jackie is a Lean Six Sigma Green Belt certified clinical research professional with 17 years of experience in clinical trial coordination and process improvement within the healthcare, biotech, and pharmaceutical industries. Since 2013, her dedicated focus has been on all things Trial Master File (TMF). Her experience includes oversight of electronic TMF (eTMF) implementations, coordination of large migration and QC projects, development of robust TMF metrics programs, overhaul of TMF processes, extensive inspection readiness preparation for FDA, MHRA, and PDMA inspections, and the creation of LMK’s accredited TMF University program.

1:30-2:15pm: The Trial Interactive Customer Journey: Client Case Studies

Our experts sit down with current Trial Interactive clients to explore their journey with them, from inception to current state. Hear personal anecdotes on key client focuses including implementation, training, and troubleshooting, and how these power users leveraged Trial interactive to the fullest while learning with us along the way.

Laurel-Ann Schrader
Director, Client Solutions
TransPerfect

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.

Brandy Ward
Associate Director, Records Information Management 
Akebia Therapeutics

Brandy Ward, Head of TMF at Akebia Therapeutics, holds a master’s degree in health science from Quinnipiac University, specializing in Medical Laboratory Science. With over 20 years of industry experience across Pharma, Manufacturing, and CRO sectors, she excels in TMF management, communication, planning, and change management. Brandy’s expertise extends to controlled documents like SOPs and WIs, along with program improvements and training. Based in Raleigh, NC, she shares her home with her husband, three cats, and a remarkable 30+ year-old parrot. Beyond work, Brandy enjoys upcycling crafts and volunteering at the Carolina Tiger Rescue.

Kristie Hosie
Senior Clinical Study Associate 
Reckitt

Kristie Hosie implemented an eTMF into a paper-based company last year, covering Medicines, Medical Devices, and Cosmetics. Kristie is currently working through the challenges of implementation and change management of this significant forward move.

Manishkumar Patel
Medical Science Systems Manager, R&D
Reckitt

Manish is a dynamic Clinical Systems Manager with 15 years of experience in Clinical Research. He is a pharmacist armed with a master’s degree in Pharmaceutical Science, he excels in optimizing clinical systems and ensuring compliance. His leadership has streamlined workflows, led staff training, and spearheaded system enhancements for improved patient care and operational efficiency. Passionate about innovation, he stays at the forefront of emerging technologies and regulatory requirements, ensuring excellence in clinical informatics. Committed to continuous improvement, Manish leverages cutting-edge solutions to empower clinicians and enhance healthcare outcomes.

2:15-2:30pm: Coffee Break

2:30-3:15pm: Helping You Win with Trial Interactive: What Customer Success can do for You

In this collaborative workshop, explore the different functions of our Customer Success team and learn how they support customers to meet their goals.

Brittany Loui
Senior Director, Life Sciences
TransPerfect

Brittany has over 25 years of management experience and 20+ in technology. She has run multiple operations, project management, customer success/client services and training teams. Brittany currently leads our global client delivery and customer success teams for the Trial Interactive division. Brittany is passionate about operational excellence and success of our clients. She brings dynamic experience to TI Professional Services having previously served in roles such as Design Engineer, Senior IT Manager, Senior Manager of Corporate Initiatives, Senior Manager of Business Operations & Strategic Initiatives, Head of Customer Care and Experiences, and Senior Director Client Services. Brittany is based in Denver, CO.

3:15-3:30pm: Closing Remarks

3:30-5:00pm: 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.

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.