Trial Interactive Customer Summit

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.

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.

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.

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.

Janice Del Rosario
Director, Clinical Operations
LMK Clinical Research Consulting

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.

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

Manishkumar Patel
Medical Science Systems Manager, R&D
Reckitt

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.

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.

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.

Sharri Adams-Edwards
Executive Director, Clinical Operations
Adverum Biotech

Sharri Adams-Edwards, a Columbia, SC native, is an expert in drug development and public health. With nearly three years at Adverum, she serves as Executive Director of Clinical Operations, overseeing vendor oversight, procurement, and RBQM strategy. Previously, she was Associate Director, Program Lead in Global Site Management and Operations at Allergan (AbbVie) Pharmaceuticals for over nine years. Sharri has extensive project and program management experience, leading teams in vaccine, NASH, infectious disease, oncology, and ophthalmology at Forest Pharmaceutical, Genentech/Roche Pharmaceuticals, and Pfizer. She also worked as an Oncology Research Nurse at Dorn VA Medical Center.

Kimberly Guedes
Vice President, Clinical Operations
Intensity Therapeutics

Kimberly (Kim) Guedes is an executive clinical development and operations leader with 30 years of experience, spanning pre-clinical, Phase I-IV trials, translational research, and multiple drug development disciplines. Kim has a wide range of experience in new product development, process improvement initiatives, portfolio and corporate integrations. In her various roles, Kim has demonstrated global regulatory and quality product development leadership. She has been responsible for product portfolios timelines, and budgets, as well as implementing policies, processes, and tools needed to optimize project execution. Her diverse experience in roles from Clinical Research Coordinator to Vice President Clinical Operations enables her to provide valuable insights across clinical development, operations, and commercial activities. Kim is an active member of the Alzheimer’s Executive Leadership Committee for the Ride to End Alz. She holds an MBA from The University of Dayton, and an RN, BSN in Nursing from Salve Regina University. Kim was awarded the Carolyn E. Green Scholarship for leadership opportunities for women in the life sciences industry.

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 has been supporting clients since 2009, focusing on document services, clinical technology, and customer success management. She has extensive experience in indexing, QC, migration, document destruction, and remapping. Lisa has also trained regulatory inspectors and supported numerous regulatory inspections. She leads a global team of project managers, overseeing projects that implement eClinical software such as eTMF, CTMS, learning management systems, quality management systems, and providing TMF services to clients.

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

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.

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

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.

Lisa Gordon
Director of Professional Services 
TransPerfect

Lisa has been supporting clients since 2009, focusing on document services, clinical technology, and customer success management. She has extensive experience in indexing, QC, migration, document destruction, and remapping. Lisa has also trained regulatory inspectors and supported numerous regulatory inspections. She leads a global team of project managers, overseeing projects that implement eClinical software such as eTMF, CTMS, learning management systems, quality management systems, and providing TMF services to clients.

Laurie Myers
Manager, Professional Services 
TransPerfect

Laurie Myers is the Manager of the Implementation Team for the Trial Interactive platform, handling solutions such as eTMF, CTMS, LMS, eISF, and Quality Docs. She oversees onboarding new clients and updating existing ones with our products’ features and functionality. Laurie joined TransPerfect after using TI eTMF for over 10 years as a client. With 17 years of experience in TMF management and the CRO clinical space, she has managed TMFs from paper to eTMF transitions, participated in audits and regulatory inspections, and authored SOPs. Laurie is committed to process improvement, quality initiatives, and enhancing user experience.

Elizabeth Davis
Project Manager
TransPerfect

Elizabeth has over 10 years of experience in the Pharmaceutical and Life Sciences industries. Prior to joining the Trial Interactive Team, she worked as a Regulatory Coordinator at the site level and provided in-house support of site and FDA audits at the sponsor level. Elizabeth has a strong focus on regulatory documentation and compliance and is passionate about coordinating with cross-functional teams to achieve success.