Seminars | Tuesday, January 21, 2020
Seminar 1
Seminar 2
Registration and Continental Breakfast
TMF 101

The creation of TMFs is not a new regulatory requirement. The ICH Guidelines have captured the requirement for their creation for over 20 years. However, who creates the content in a TMF, in what filing location/repository that content is kept during and after the trial, how timely the content gets into the repository, and the check to make sure that set of content is complete and inspection-ready on an ongoing basis is what makes the TMF challenging. The processes for the management of the TMF are not passive, should not be reactive, but instead are best when done as an active process.

The human eye and brain have a large part in ensuring the TMF is complete and inspection-ready. This course will show participants how metrics can keep a company on the road for compliant healthy TMFs. A review of newly emerging technology and risk-based processes that assist in assessments of the quality and completeness of the TMF will be conducted. Participants will get introductions to these emerging techniques; some of which are free through merely adjusting a risk tolerance.

Upon completion of this course, participants will know how or be able to:

  • Cite current laws, guidanc,e and regulations that govern TMF administration
  • Understand recent and pending industry-wide trends
  • Review the requirements for an inspection-ready TMF and as well as how these are accomplished by considering the people, the processes in place, and the system that holds the content
  • Apply TMF metrics that drive TMF health assessments at their companies
  • Know the latest emerging technologies that help to review the TMF’s completeness
June Buchanan, Director, Clinical Operations, TESARO
Lisa Mulcahy, Owner and Principal Consultant, MULCAHY CONSULTING

Ensuring your TMF is inspection ready is no easy task. Working internally and externally to collect, organize, and manage all the information and documents that comprise your TMF is essential to preparing for a regulatory inspection. Figuring out how to effectively collaborate and implement processes that focus on quality and completeness is one of the first steps to proactively maintain inspection readiness throughout a trial in small- to mid-size companies. A key part of inspection preparation is identifying the content that results in an inspection-ready TMF.

Discussing major pain pints, looking at case studies, and participating in interactive Q&A are some of the ways we plan to prepare seminar attendees for various inspections. This session will also identify strategies for preparing for some of the recent changes in inspection strategies of the EMA and FDA.

Upon completion of this course, participants will know or be able to:

  • Identify risk factors that lead to potential gaps in TMF inspection readiness in areas of content and resources
  • Develop a strategy for remediating an at-risk TMF as part of inspection preparation
  • Balance the resources required to adequately prepare for inspection against the available resources and identify where supplemental resources are required
  • Understand the requirements of maintaining a TMF that has a constant state of inspection readiness
  • Demonstrate understanding of inspection preparation and how it impacts efforts to maintain an inspection-ready TMF
  • Leverage the value of a mock inspection when establishing inspection readiness to ensure that the TMF reflects the storyboard of the study
  • Utilize the TMF when working with outsourcing partners and sites in preparation for inspections
  • Discuss current inspection trends and preparations specific to your organization's current state
Donna Dorozinsky, President, JUST IN TIME GCP
Jenn Embury, Manager, Clinical Customer Success, VEEVA
Jay Russak, Clinical Team Lead, DICENRA PHARMACEUTICALS
Wendy Trimboli, Senior Director, Clinical Operations Systems, Process and Inspection Readiness, ACADIA PHARMACEUTICALS
*Seminars include lunch and two networking breaks.
Seminars Conclude
Dinner Workshops | Tuesday, January 21, 2020

Advance the TMF Quality Review Game

Emerging technologies and processes can assist companies in the assessment of the quality and completeness of their TMFs. With the utilization of risk assessments, selection of content to review based on type and percentages, and artificial intelligence that predicts areas of weakness to address, a company that employs these techniques may feel that they have a complete TMF quality review process that covers all areas. Might there be some areas that remain that still aren't checked and therefore leaves a TMF at risk?

This dinner session will provide a targeted review of each of the techniques for calculated and automated quality review. These will be used as the foundation for participant brainstorming sessions that will challenge peer groups to identify the gaps that still exist and propose potential solutions based on what is currently available and what is yet to be developed. No idea is too far-fetched or unreasonable to explore and put suggestions forward as a solution.

Following this course, participants will be able to:

  • Name three emerging technologies and processes that are assisting companies in their conduct of quality reviews and completeness of their TMFs
  • Identify gaps in the existing business process and corresponding eTMF technologies
  • Propose potential solutions to close the gaps
Lisa Mulcahy, Owner and Principal Consultant, MULCAHY CONSULTING
Vinay Parachuri, Practice Head — Life Sciences, PHARMA TEK SOLUTIONS
TMF Management Plan

The TMF Management Plan is the first artifact of the TMF Reference Model created by the DIA Working Group. You may ask…why is that? Because it is important! It sets the expectations for the Trial Master File for each clinical study. While its content will vary from company to company, in this workshop we will review the constructs of the TMF Plan Template created by a subgroup of the DIA TMF Reference Model and use real examples of how to create your plan for your company.

This dinner seminar will review the expectations of regulatory authorities as well as best practices from the presenters.

Topics that will be addressed during this workshop are:

  • View the TMF Management Plan through the eyes of health authorities
  • Clarify how critical the TMF Management Plan is to overall TMF Management processes
  • Take a walk-through of the TMF Plan Template created by the TMF RM subgroup, reviewing and explaining each component.
  • Get and generate ideas for quality reviews
  • Draft creation of your own TMF Plan Template
Jamie Toth, Director and Head of TMF Operations, DAIICHI SANKYO
Wendy Trimboli, Senior Director, Clinical Operations Systems, Process and Inspection Readiness, ACADIA PHARMACEUTICALS
*Workshops includes a working dinner and one networking break.
Dinner Workshops Concludes
Main Conference Day One | Wednesday, January 22, 2020
Continental Breakfast and Registration
Summit Chairpersons’ Opening Remarks
Wendy Beeby, Director, Clinical Document Management, Inspection Readiness and Trial Support, TAKEDA
Grace Crawford, Global Head of Clinical Quality and Compliance, ASTRAZENECA
Marie-Christine Poisson-Carvajal, Senior Director, Head of TMF and Registry Operations, PFIZER
Karen Roy, Chief Strategy Officer, PHLEXGLOBAL
Jamie Toth, Director and Head of TMF Operations, DAIICHI SANKYO
TMF Quality: Improvement Through Metrics Implementation
  • Review how to collect eTMF metrics and what KPIs you should focus on
  • Discuss the ways those metrics should be used and pinpoint strategies for employing actionable tactics based on your measurements
  • Learn how to use these metrics across your organization to consistently improve your TMF Quality
Alex Markiel, Director, Clinical Records Management (CRM) and Trial Operations Platforms, Global Development Operations, PHARMACYCLICS
How Digital Disruption Is Shaping TMF Technology to Drive TMF Health
  • Understand the role of disruptive technology
  • Use cases of technology addressing quality, timeliness, and completeness
  • Balance this technology with experienced people trained on effective processes to reach the TMF Health Zone
Karen Roy, Chief Strategy Officer, PHLEXGLOBAL
Barry Sacks, Chief Technology Officer, PHLEXGLOBAL
Networking Break
PANEL DISCUSSION: Enhance Collaboration Between Sponsors, Sites, and CROs to Improve TMF Quality
  • Discuss the best practices for TMF collaboration between the key stakeholders
  • Understand the challenges and pinpoint solutions when using a combination of CRO-owned eTMFs and sponsor-owned eTMFs
  • Hear how experience in various stakeholder roles impacts the development and implementation of TMF systems and processes
  • Gain actionable strategies used by your peers to enhance TMF quality
  • Garner tips for auditing and QC from multiple perspectives
Kristen Bretzius, Manager, TMF Governance, TEVA PHARMACEUTICALS
Etienne Hinton, Clinical Trial Coordinator, DUKE CLINICAL RESEARCH INSTITUTE
Aryn Knight, Administrative Director, Center for Clinical Research, TEXAS HEART INSTITUTE
JP Miceli, Associate Director of Document Management, ADVANCED CLINICAL
Laura Naranjo, Associate Director, TMF Operations, DAIICHI SANKYO
Joaquin Sosa, Director, TMF Operations, SYNEOS HEALTH
Applying Machine Learning to Transform TMF Document and QC Processes
  • Review some of the challenges clinical study teams face today with document processing and quality control
  • Explore potential opportunities to deliver higher quality with less burden
  • Hear Lilly detail a machine learning pilot within Veeva Vault Clinical and understand how their learnings could deliver measurable improvements and potential cost reductions for TMF document and QC processes
  • Discover how machine learning could impact the future clinical operations landscape - from the smallest biotech to big pharma
Nicole Sheetz, Director, Clinical Design, Delivery and Analytics, ELI LILLY
Kyle Stephenson, Clinical Product Manager, VEEVA
Networking Luncheon
Tracked Sessions | Main Conference Day One | Wednesday, January 22, 2020
TMF Operations
Functional Areas
Track Chair:
Grace Crawford, Global Head of Clinical Quality and Compliance, ASTRAZENECA
Track Chair:
Karen Roy, Chief Strategy Officer, PHLEXGLOBAL
Track Chair:
Marie-Christine Poisson-Carvajal, Senior Director, Head of TMF and Registry Operations, PFIZER
Eli Lilly: The Journey Continues: Implementing Strategy and Improving Transparency, Oversight, and Quality of TMF
  • Press the Reset Button — a brief overview of the start of our journey and new strategic direction
  • Learn how the use of milestones and expected document lists have improved transparency, oversight, and quality control
  • Hear about training and performance support, lessons learned and steps to improve impact
  • Inspection lessons learned
Patty Fulton, Quality Consultant, Trial Master File, ELI LILLY
Sponsor Oversight — Process and Technology
  • New systems relieve old process burdens and allow us to identify problem areas (to see what we have been missing)
  • Risk-based systems and AI — How do these impact Sponsor Oversight, make some things easier?
  • How do you track/demonstrate oversight? Is it part of a system or systems? Where should it live?

Gillian Gittens, Customer Success Manager, IQVIA TECHNOLOGIES
Lou Pasquale, Director, Customer Success, IQVIA TECHNOLOGIES
Internal Stakeholder Collaboration: Explore Functional Areas
  • Understand how to use the TMF reference model to enhance collaboration between various functional areas
  • Discuss the process of collecting critical data from the responsible parties
  • Determine effective strategies for approaching various functional areas to maximize understanding
June Buchanan, Director, Clinical Operations, TESARO
Transition Time
Implementation and Adoption of eTMF: Lessons Learned in Smaller Pharma Organizations
  • Understand the journey of integrating an eTMF, starting with implementation
  • Define a long-term strategic plan to outline success factors, vendor selection, and technology to re-engineer your business processes
  • Analyze effective collaboration between business and IT roles
  • Discuss good governance principles that both engage management and empower teams
  • Accept realistic expectations of “perfection” while always being ready to adapt and improve
Nick Hargaden, Associate Director, Clinical Systems, AGIOS
Use a Data-Driven eTMF to Improve Quality, Timeliness and Completeness with Contributors
  • Ensure quality, timeliness, and completeness of eTMF by using operational data to interconnect clinical processes, activities, and events
  • Gain visibility of what artifacts are actually required and the lack of triggers present to prompt contributors
  • Employ operational data and data management strategies to ensure the highest quality eTMF
  • Improve how we predict and manage artifacts through the use of predictive analytics based on central process models and data management techniques
Paul Fenton, Founder and CEO, MONTRIUM
Explore the Creation of TMF Ambassadors Within Your Company
  • Learn how to embed a TMF Culture in your organization
  • Establish Change Management strategies
  • How to avoid and overcome pitfalls and challenges
  • Recognize the need to continuously revamp strategy
  • Focus on creative approaches to maintain ongoing commitment
James Martin, Director, TMF Operations – CDS, SYNEOS HEALTH
Networking Break
Fostering a Digital Document Ecosystem in Clinical Trials
  • Explore the exceptional benefits of establishing an end-to-end digital document ecosystem
  • Review the current obstacles that prevent a fully digital ecosystem
  • Gain an understanding of regulatory documents from the study site perspective
  • Discuss the evolving role of the CRA in monitoring study sites and managing documents
  • Understand the necessary steps among all parties to foster a digital document ecosystem
Bill Cooney, President and CEO, MEDPOINT DIGITAL INC.
Panel Bridge the Gap Between Sponsors and CROs
  • Hear from various TMF stakeholders about working together to manage a TMF
  • Analyze the individual and collaborative efforts taken by both parties to prepare their TMF for inspection
  • Pinpoint challenges incurred along the way and discuss strategies used to overcome those hurdles

Dawn M. Niccum, Senior Director of QA and Compliance, INSEPTION GROUP


Alex Markiel, Director, Clinical Records Management (CRM) and Trial Operations Platforms, Global Development Operations, PHARMACYCLICS
Supriya Shoroff, Head of TMF Operations, AMAG PHARMACEUTICALS
Stephanie Viscomi, Associate Director, TMF Compliance and Education, ALEXION

Trial Master File Implementation: Create and Maintain Value for Stakeholders
  • Understand the regulatory and business benefits of introducing a comprehensive TMF process
  • Discuss how to approach the introduction of a TMF to ensure that Key stakeholders are invested in the process.
  • Pinpoint what the likely barriers to be faced and how to mitigate them
  • Learn how to maintain compliance after implementation and the added value that brings to clinical programs
Brian Dempster, Director, Clinical Affairs, ENDOLOGIX
Transition Time
Analyze the Process of Transitioning from a Homegrown SharePoint Document Retention to an eTMF Application
  • Discuss the clinical and business considerations that led to the decision to purchase an eTMF software
  • Understand the systems and processes created to make this transition
  • Understanding the implications for past and ongoing studies during the transition
  • Pinpoint the resources needed to use eTMF software
  • Analyze the strategic considerations to discuss with various management levels to increase efficiency
Shannon Simpson, Trial Master File Manager, PATH
Panel Discussion Collaborate With CRO Partners When Archiving to Achieve Inspection Readiness
  • Discuss the process of archiving closed out studies when working with paper and electronic documents from multiple sources
  • Understand the impact of securing documents from a shared drive and transferring them to an eTMF
  • Explore a case of inspection readiness and the process taken to ensure documents were prepared and compliant
  • Analyze project with partners in preparation

Laura Naranjo, Associate Director, TMF Operations, DAIICHI SANKYO


Martina Duevel, Systems Excellence Project Leader, BAYER
Hobson Lopes, Manager, Clinical Archive, REGENERON PHARMACEUTICALS

Don’t Swipe Left on Your GMP (Clinical Supplies) Function: Turn Your Next Bitter Fight With GMP Into a Meet-Cute
  • Learn about your GMP function’s winning qualities
  • Discover that what happens in Zone 6 doesn’t always stay in Zone 6
  • Understand how GCP and GMP functions can learn to embrace their differences and find common ground
  • Return to work equipped to take your relationship with your GMP function to the next level
Sonja Davis, Associate Senior QA Consultant, QA-Product Research and Development, ELI LILLY
Thomas Miller, Product Delivery Consultant - Design Hub, ELI LILLY
Minette Pugh, Advisor, Quality Systems and Compliance Management, ELI LILLY
Networking Reception
Day One Concludes
Main Conference Day Two | Thursday, January 23, 2020
Inspection Readiness
eTMF and Technology Enhancements
Continental Breakfast
Track Chair: Wendy Beeby, Director, Clinical Document Management and Inspection Readiness, TAKEDA
Track Chair: Jamie Toth, Head of TMF Operations, DAIICHI SANKYO
Track Chair: Karen Roy, Chief Strategy Officer, PHLEXGLOBAL
TMF Oversight in an Agile Setting: A Case-Story on New eTMF Implementation
  • Agile eTMF implementation
  • Agile process writing
  • Assuring regulatory compliance by implementing a centralized TMF oversight strategy
  • Approach to oversight in an agile setting
Dorte Frejwald Christiansen, Competency Development Specialist, NOVO NORDISK
Anne-Mette Varney, Principal Competency Development Specialist, NOVO NORDISK
Build Inspection Readiness Into Your TMF Operations
  • Identify roles of team members and determine who is responsible for documents, data, and Quality checks
  • Utilize proper oversight to identify gaps in completeness
  • Communicate internally to foster buy-in from functional areas and their teams; instill a culture of preparedness
  • Analyze how TMF teams can improve support of inspections
  • Realize the importance of looking at TMF in the broad perspective
Karen Whitson, Assistant Director, Clinical Documentation Center, ABBVIE
Establish Processes for System Enhancements That Benefit Global End-Users
  • Coordinate globally with colleagues to collect and analyze potential system enhancements
  • Develop a process for communication and education that includes input from users
  • Analyze cases of change and the implications of those changes
  • Discuss strategies for user buy-in and training
Laura Naranjo, Associate Director, TMF Operations, DAIICHI SANKYO
Keith Win, Senior Business Analyst, TMF Operations, DAIICHI SANKYO
Transition Time
Enhance Staff Education When Implementing a New QC Process
  • efine SOPs and processes needed to enhance Quality
  • Discuss what staff roles are from contributors to managers
  • Teach the QC process to the people handling the information
  • Explore the relationship between building staff education and process roll-out
Stephanie Viscomi, Associate Director, TMF Compliance and Education, ALEXION
Case Study Inspection Readiness One Year Later
  • Analyze Biogen’s experience during a prolonged inspection notification window
  • Detail the process their team went through to prepare
  • Understand the challenges of engaging staff across the organization while supporting personnel’s inspection readiness efforts
Dawn Clowes, Manager, Regulatory TMF, BIOGEN
Liz Farrell, Senior Manager, TMF, BIOGEN
Practical ClinOps Applications of AI and Machine Learning – Real-World Use Cases
  • Gain strategies for practical use of technologies for document classification, metadata extraction, and Quality and regulatory review
  • Discuss how to improve efficiency throughout clinical trials with machine learning
  • Determine the use cases that are most relevant and applicable in clinical operations
  • Describe examples of how these technologies are being used and will be used in the future
Jay Smith, Senior Director, Product, Trial Interactive, TRANSPERFECT
Networking Break
Understand the Quality Factors That Define TMF Completeness
  • Discuss the best practices in TMF QC
  • Understand the importance of sharing knowledge and discover effective methods for training staff based on personal experience
  • Develop various methods of auditing to increase efficiency within your TMF processes
  • Analyze the relationship between Quality and completeness to ensure confidence when preparing for an inspection
Evelin Baez, Senior Clinical Operations Specialist, BD
Analyze Email Correspondence and Inspection Readiness
  • Discuss inspection trends related to relevant email communications and TMF content
  • Pinpoint different methods used to include correspondence in clinical records
  • Recognize the impact your organization’s SOPs have on your filing process
  • Explore technology solutions that can automate the process
Lori J. Ridge, Senior TMF Project Manager, MYLAN PHARMACEUTICALS
Case Study In Migration
  • Understand the common challenges and struggles of eTMF migration and critical factors to be considered by TMF teams
  • Explore the process of migration when working with CROs and other vendors
  • Recognize the learning curve and gap in information among personnel involved in the migration
  • Discuss essential components of a migration strategy and planning this process
Supriya Shoroff, Head of TMF Operations, AMAG PHARMACEUTICALS
Transition Time
Case Study Improve Completeness and Inspection Readiness With an Active TMF Management
  • Analyze how a small biopharma company transitioned from passive TMF management to active TMF management to enhance completeness and inspection readiness
  • Discuss processes for identifying gaps without the use of an eTMF system
  • Establish benchmarks and triggers that can drive engagement from functional groups and identify issues before the trial and throughout the trial
Ashlyn Deshaies, Clinical and TMF Operations Manager, TG THERAPEUTICS
The Fully Automated eTMF: Vision and Reality
  • Introduction: The journey from eTMF implementation through maturation to the vision
  • Vision of a fully automated eTMF and the implications
  • Route to a fully automated eTMF and the challenges
Martina Duevel, Systems Excellence Project Leader, BAYER
Debra Wells, Sr. Manager, Global Regulatory Systems and Process Management, EISAI
Networking Luncheon
Understand the Relationship Between TMF Quality and Technology to Improve Inspection Readines
  • Discuss the intersection between data quality and technology systems in TMF and pinpoint metrics that are important to monitor
  • Analyze reporting processes that can help ensure quality and compliance
  • Explore dashboard and dissect what information you should look for
  • Gain an understanding of war-room activities and preparations leading up to an inspection
  • Share inspection experiences
Karen Freid, Essential Document Specialist, MERCK
Bryan Souder, Director, TMF Head, MERCK
Panel Discussion Improve TMF Quality With Innovative Technology and Enhancements That Elevate TMF Operations
  • Mitigate risks and maintain compliance within your eTMF system
  • Take a proactive approach to TMF management by reviewing current processes and SOPs
  • Pinpoint strategies to analyze the current state of your TMF Quality, and combat common issues
  • Discuss the relationship between inspection readiness, Quality and technology
  • Weigh the pros and cons of leveraging a unified end-to-end solution

Karen Roy, Chief Strategy Officer, PHLEXGLOBAL


Rebecca Halbur, Senior Manager, TMF Systems, BIOGEN
Perry Steinberg, GM & VP, Product, MEDIDATA, a Dassault Systèmes company
Keith Win, Senior Business Analyst, TMF Operations, DAIICHI SANKYO

Inspection Experiences: Stories From the Front Line

Case 1: New-Age Inspection Practices Require New Thoughts on Policies and Access
Hobson Lopes, Manager, Clinical Archive, REGENERON PHARMACEUTICALS

Case 2: Using Inspection Experience and Corrective and Preventative Actions to Set New Expectations and Communicate Lessons Learned
Tatsiana Brady, Senior Manager, Audit and Inspection Readiness, Specialty Clinical Development and Global Medical Affairs, TEVA

Case Study Preparing for Office-Based Inspections Within a Global Organization
Noreen Bouchard, Senior Manager, Central Medical Files, ASTELLAS
Jessica Chamberlain, Records Analyst, Central Medical Files, ASTELLAS
Chairpersons’ Closing Remarks
Wendy Beeby, Director, Clinical Document Management, Inspection Readiness and Trial Support, TAKEDA
Grace Crawford, Global Head of Clinical Quality and Compliance, ASTRAZENECA
Marie-Christine Poisson-Carvajal, Senior Director, Head of TMF and Registry Operations, PFIZER
Karen Roy, Chief Strategy Officer, PHLEXGLOBAL
Jamie Toth, Director and Head of TMF Operations, DAIICHI SANKYO
Conference Concludes

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