Preconference Training Day | Tuesday, January 22, 2019
Registration and Continental Breakfast

The TMF management process has a lot riding on it — an inspection-ready TMF on an ongoing basis. The development of the process starts with understanding the entire suite of process documents required to ensure a complete and inspection-ready TMF. By understanding the requirements of a crossfunctional and vendor-involved process, you will begin to understand how to develop the TMF management SOP so that it will cover the entire set of TMF content, involve all of the contributors to the TMF, and meet the requirements for timeliness, completeness, and quality.
During this interactive seminar, attendees will

  • Review of the suite of TMF management process documents and why each one is critical to the complete process
  • Discuss the roles and responsibilities of the internal and external teams, including CROs and vendors
  • Explore the sponsor/CRO relationship for management of the TMF and how this definition, when captured in the process documents, leads to early success in the management of the study specific TMF
  • Develop the template of a comprehensive TMF Management SOP, capturing challenges and lessons learned to take back and apply in your own company
  • Lead - Lisa Mulcahy, Owner and Principal Consultant, MULCAHY CONSULTING
  • Martina Duevel, Systems Excellence Project Leader, BAYER
  • Lisa Joseph, Senior Manager, Process, Training and Compliance, TAKEDA
  • Stephanie Viscomi, Associate Director, Clinical Trial Office, IMMUNOGEN

A highly functional TMF Resourcing team is critical to the successful management of the TMF. Achieving quality and inspection readiness of a TMF, and doing so efficiently, is realized by recognizing and synchronizing a myriad of factors, not the least of which are the establishments of comprehensive process definition, job roles, and responsibilities. Every trial is different, so the TMF Operations team has to be nimble to help the study team achieve the goal of an inspection-ready TMF during the conduct of the study. This seminar will look at the hard skills and the soft skills of a variety of TMF representatives and the interplay of those skills to each clinical study which are all the same and different at the very same time.
During this interactive workshop, attendees will

  • Clarify the scope of a TMF Operations team’s functions in well-defined rules and SOPs
  • Examine the processes and events that impact TMF management throughout the life cycle of a clinical study
  • Define your TMF Operations team, the structure, and a progression plan
  • Understand the roles and responsibilities for each of the positions and how they impact the processes and events put in place for successful support of the TMF management process and events
  • Donna Dorozinsky, President, JUST IN TIME GCP
  • Barbara A. Novak, Senior Manager, Clinical Operations, Kyowa Kirin Pharmaceutical Development
  • Casey Ryan, Clinical Applications Specialist, BECTON DICKINSON
  • Melissa Umbehauer Chiasson, Senior Manager, Process, Training and Compliance, TAKEDA

*Seminars include lunch and two networking breaks

End of Seminars

Adequate TMF management support for your trial will be a significant and persistent issue unless operations, resources, and processes are aligned. Before beginning study start-up, it’s important to take a step back to survey the landscape from a TMF-management perspective. There are so many questions to ask about study design and external vendor utilization that could affect the inspection readiness of the TMF during and after the study. The TMF Operations team needs to match skills with the study needs. Defining the TMF Operations resourcing plan is pivotal to success in addition to well-defined SOPs. Notably, this workshop will include 1) an examination of two case studies from organizations that had to review their TMF team, and 2) a minds-on group exercise.

  • Survey your situation and examine each trial to determine TMF Operations-related processes and needs
  • Identify the pivotal and often nuanced distinctions among trials that impact successful TMF management
  • Assess adequacy of available resources necessary for peak operations support
  • Hear about real-world examples as case studies that highlight pitfalls and key elements of success
  • Work with a group to devise an approach from different points of view
Lead - Lisa Mulcahy, Owner and Principal Consultant, MULCAHY CONSULTING
Alex Markiel, Director, Clinical Operations, Head of Clinical Document Control, PHARMACYCLICS
Colleen Maude, Director, Trial Master File, MEDIMMUNE

*Workshop includes a working diner and one networking break.

Dinner Workshop Concludes
Plenary Sessions | Conference Day One | Wednesday, January 23, 2019
Registration and Continental Breakfast
Chairpersons’ Opening Remarks
Wendy Beeby, Clinical Document Management and Inspection Readiness, SHIRE
Grace Crawford, VP Clinical Quality and Compliance, MEDIMMUNE
Marie-Christine Poisson-Carvajal, Head of TMF Operations, PFIZER
Karen Roy, Chief Strategy Officer, PHLEXGLOBAL
Pfizer Case Study Reduce Errors in Clinical Trial Documents Through Automation
  • Hear about the journey to use automation to reduce human errors in clinical trial documents
  • Explore the limits and the possibilities of automation
  • Look at the roles the various functions are playing to implement solutions
  • Avoid pitfalls of automation by hearing lessons learned
Mary Emanoil, Senior Director, Content Management and Authoring, PFIZER
Apply Machine Learning and Artificial Intelligence
  • Hear case examples of AI application in TMF
  • Anticipate the skill sets that will need to be phased in/out
  • Learn the benefits and risks of AI and machine learning to Quality and inspection readiness
  • Determine where/how your particular needs should guide the level/type of AI
  • Discuss the impact of AI on TMF processes and what adaptations are needed
  • Look at the future role of AI to TMF and the industry
Barry Sacks, Chief Technology Officer, PHLEXGLOBAL
Networking Break
Collaborate Effectively to Transform Clinical Trials
  • Discuss opportunities to transform trial execution through greater TMF collaborations
  • Explore innovative ways to enhance collaboration by automating the exchange of TMF data between sponsors, CROs, and sites
  • Learn how to gain and leverage continuous visibility of clinical data exchange to improve oversight, compliance, and decision-making
Mark Romano, R&D Customer Success Manager, VEEVA
Case Study Improve Quality and Execute a Culture Change Through Assessing and Addressing TMF Stakeholder Input
  • Understand how process changes driven by TMF stakeholder input will improve the management and quality of TMF records
  • Develop a culture change and implement across regions and functions
  • Create a governance structure with clear accountability for contributing functional areas
  • Implement a quality oversight process with functional accountability
Patty Fulton, Quality Consultant, TMF, ELI LILLY
Maintain an Inspection-Ready TMF With a Comprehensive and Coherent Approach by Accounting for Variables in Your Quality Management System
  • Evaluate quality control processes based on viability and efficacy
  • Compare roles and expectations of CROs of varying sizes
  • Look at the impact of a variety of internal structures and operations of sponsors on QC and risk factors
  • Deliberate the merits, drawbacks, and resources of training and support programs
  • Discuss key components of a TMF Management and avoid pitfalls
  • Consider and surmount obstacles to CRO oversight and QC in a third-party owned system
Networking Luncheon
Tracked Sessions | Conference Day One | Wednesday, January 23, 2019
Wendy Beeby, Clinical Document Management and Inspection Readiness, SHIRE
Marie-Christine Poisson-Carvajal, Head of TMF Operations, PFIZER
Karen Roy, Chief Strategy Officer, PHLEXGLOBAL
Case Study Tailor Metrics to Particular Functional Areas to Identify Issues
  • Use eTMF metrics derived from functional input to increase active participation in TMF responsibilities
  • Identify issues and areas for improvement in different functional areas and track progress
  • Ensure that metrics from the eTMF are actionable and will be useful for regulatory reports
Jason Weinstein, Business Lead and Manager, eTMF, REGENERON
Learn About the Framework for the Destruction of Paper and Discuss Its Ramifications
  • Survey the current framework
  • Learn what the proposed changes will entail
  • Hear about what the framework will be and how it will change your work
  • Discuss tools that will be available
  • Benefit from lessons learned and address pain points
Liz Farrell, Senior Manager, TMF, BIOGEN
Curran Murphy, Director, Clinical Operations, DECIPHERA PHARMACEUTICALS
Panel Look at Proactive and Coping Measures for TMFs With Limited Resources at Start-Up
  • Prepare for real challenges of document management associated with start-up and beyond
  • Evaluate the processes that ensure quality and support document needs
  • Discuss realistic approaches and solutions for supporting completeness and inspection readiness
  • Avoid pitfalls of TMF start-up through tactical suggestions and insights from a CTA/CRA/ CTM perspective
  • Identify and communicate the most vital information to TMF stakeholders struggling to prioritize TMF

Alex Markiel, Director, Clinical Operations, Head of Clinical Document Control, PHARMACYCLICS


Sabrina Owens, Clinical Trial Administrator, CHIESI
Miriam Philmon, Clinical Research Manager, MYLAN
Mindy F. Taback, Clinical Trial Associate, AERIE PHARMACEUTICALS

Transition Time
Address Escalating TMF Resource Needs Using Risk-Based Approaches
  • Counter the need for increased resources resulting from the addition of a clinical study
  • Discuss the correlation of risk-based approaches to the value and abilities of smaller teams
  • Examine risk-based approaches that reduce costs while maintaining a high-quality TMF
  • Focus QC on factors that affect quality based on evidence gathered from metrics
  • Rank documents based on risk to concentrate QC resources on higher risk documents
  • Identify study and site risk factors that may result in the need for a higher level of scrutiny
  • Design processes that avoid the need to organize, file and retain paper documents
Kathie Clark, Vice President, Product Management, WINGSPAN TECHNOLOGY, AN IQVIA COMPANY
Use AI to Improve Efficiency in Filing, Indexing Documents, and Completeness and Accuracy of the TMF Content
  • Leverage document content authoring to define TMF specifications
  • Design smart tools to perform TMF content review
  • Example of a business case for next eTMF generation at Pfizer that describes how efficiency can be gained using Automation
  • Project the effects of AI on of workforce profile and skill sets
  • Convince senior management to accept the process and invest
Elisa Murphy, Senior Information Manager, PFIZER
Marie-Christine Poisson-Carvajal, Head of TMF Operations, PFIZER
Meet ICH E6(R2) Expectations of Regulators Through CRO Oversight and Collaboration
  • Look at what types of document are required by ICH E6 (R2)
  • Examine the risk-based approach to CRO/vendor management
  • Work with CROs to implement and make sure sites are on board
  • Look at metrics that ensure ongoing trial inspection readiness
  • Conduct oversight of CRO
Ann McCabe, Director, Process Excellence and Risk Management Clinical Development Operations, DAIICHI SANKYO
Networking Break
Shift the Paradigm to Measure What Matters

This minds-on session will challenge participants’ conceptions of their measurement practices. Case examples will be discussed to reveal alternatives to evaluate and monitor trials.

  • Invoke change by challenging your metrics and how you use them
  • Assess on the accuracy and efficacy of your metrics
  • Question what you are measuring and what can be measured
  • Deliberate the variety of possible interpretations of the same measure
  • Find out if your measure is telling you what you think it is
Liz Farrell, Senior Manager, TMF, BIOGEN
Ensure Seamless Audits by Making the Most of What Your eTMF Offers
  • Make an eTMF your primary tool for an efficient, successful audit
  • Discover your eTMF’s capabilities for options to best analyze the health of your TMF
  • Understand the importance of effective metadata; how it can affect audits and all users of the system
  • Create a proactive approach and confident outlook on audit readiness with your QC Process
  • Hear best practices on metadata clean-up for reliability
  • Use your eTMF to its full potential for efficient retrieval of inspection documents
Evelin Baez, Clinical Document Management Specialist, BECTON DICKINSON
Enhance Your CRO/Sponsor Relationship While Maintaining a Constant State of Inspection Readiness
  • Know and convey the “Ins and Outs” of the DIA filing matrix
  • Deal with pushback from CROs by sharing the onus of QC and inspection readiness
  • Improve collaboration by changing your mindset and language ((i.e., use “input” or “feedback” as opposed to “pushback”)
  • Discuss best practices working with multiple CROs with far-ranging cultures, needs, resources and expectations
  • Establish expectations and provide support
Laura Tenbrink, TMF Manager, XCOVERY
Transition Time
Case Study Learn About AbbVie’s Risk- Based QC Process
  • Achieve risk-based QC for completion, timeliness, and quality
  • Develop metrics with intent to identify the most relevant risk factors
  • Account for heightened risks resulting from new and pending regulations
  • Adapt governance processes to deliberate over causes and necessary modifications
  • Identify studies that may need more support
Nela Hayes, Senior Manager, Clinical Documentation, ABBVIE
Karen Whitson, Assistant Director, Clinical Documentation Center, ABBVIE
Case Study Plan and Execute Migrations of Disparate Types of TMFs
  • Anticipate and avoid inspection readiness pitfalls
  • Determine what QC measures should be taken before and after migration
  • Hear about specific challenges and lessons learned in various scenarios, including:
    • CRO Paper TMF to Sponsor eTMF
    • CRO eTMF to Sponsor eTMF
    • Mid-Study Paper TMF to Sponsor eTMF
    • Transition from Acquisition TMF to Sponsor eTMF
Victoria Ho, Director, Clinical Operations, GILEAD
Case Study Provide Inspection Support With Comprehensive Guidance, Instruction, Training and Support to CROs Using Their Own eTMF System
  • Compare and contrast inherent challenges of maintaining an exchange-ready eTMF when using large vs. small CROs
  • Discuss advantages and disadvantages of inspection preparation using a CRO’s eTMF
  • Hear how groups and committees conduct oversight at Merck
  • Overcome transparency issues and through good governance and Quality Management Systems
Karen Freid, Essential Document Specialist, MERCK
Networking Reception
Day One Concludes
Tracked Sessions | Conference Day Two | Thursday, January 24, 2019
Continental Breakfast Begins
Track Chair Recap Day One
Grace Crawford, VP Clinical Quality and Compliance, MEDIMMUNE
Track Chair Recap Day One
Karen Roy, Chief Strategy Officer, PHLEXGLOBAL
Track Chair Recap Day One
Panel Prepare for a TMF Inspection With a Quality Management System
  • Manifest prioritization drivers in your metrics to avoid critical findings
  • Hear examples of mock audits improving inspection readiness by informing process modifications
  • Hear how various constituencies are involved in inspections
  • Conduct audits in accordance with inspection trends and pending changes
  • Survey common pitfalls for inspections and discuss how they may be avoided

Bryan Souder, Director, TMF Head, MERCK


Sheryl Crean, Director Quality Assurance Strategic Advice- Science Unit QA, GCP and PV, ASTRAZENECA
Janis Hall, Senior Consultant, THE AVOCA GROUP
Dawn M. Niccum, Senior Director of QA and Compliance, INSEPTION GROUP
Melissa Umbehauer Chiasson, Senior Manager, Process, Training and Compliance, TAKEDA
Stephanie Viscomi, Associate Director, Clinical Trial Office, IMMUNOGEN

Case Study Steps to Build a Robust Function QC Process to Ensure IR
  • Look at examples of tailored quality metrics and tools for particular functional areas
  • Learn how Daiichi Sankyo on-boarded leaders and staff in functional areas
  • Discuss examples of ways that collaboration is facilitated throughout QC
  • Hear lessons learned for planning, piloting and implementing
  • Improve IR by customizing steps to address nuanced needs of various functions
Christina Allen, Senior TMF Specialist, TMF Operations, DAIICHI SANKYO
Laura Naranjo, TMF Operations, Clinical Development Operations Function, DAIICHI SANKYO
Leverage Your eTMF Technology to Engage Stakeholders Through a Business – IT Approach
  • Create a cohesive team of clinical trial management TMF SME’s throughout various functions
  • Customize upgrades to your eTMF systems based on user need
  • Keep people focused on meaningful tasks by leveraging new functionalities
  • Develop synergy between the business and IT
Rebecca Halbur, Senior Manager, TMF Systems, BIOGEN
Transition Time
Contend With Pain Points of Acquisition to Passing Inspection
  • Recognize the impact of merging TMFs on compliance
  • Examine impediments to inspection readiness resulting from M&A
  • Identify priority areas to focus on based on inspection trends
  • Sort out first steps and steps most often neglected in the planning process
  • Know what to look for in audits to identify issues of document management
  • Establish responsibilities and provide essential training for internal functions, CROs and sites
Alana Wriggins, Head Site Management, NA, Acquisition Integration and Clinical Records Management, ALLERGAN
Case Study Business Embedment: Influence Corporate Strategy With C-Level Buy-In
  • Hear how MedImmune’s TMF department leads the initiative to develop corporate management strategy gg Examine history of AstraZeneca that established the need for change in the framework
  • Explore operating model TMF put forth to corporate for that garnered their support
  • Get license from corporate to infiltrate all levels of organization
  • Determine corporate level goals based on corporate level needs
  • Learn how without additional resources departments compensated
Colleen Maude, Director, Trial Master File, MEDIMMUNE
Improve Interoperability Through Automation
  • Learn the implications of the TMF Exchange Mechanism for TMF automation
  • Outline the benefits and explore the limits of automation to improving TMF systems and processes
  • Review functional systems that draw from or impact eTMF content
  • Expedite and augment interoperability by using AI to extract artifacts, emails, and data
Networking Break
Case Study Achieve a Single Source of Truth (SSOT)
  • Understand the benefits of a “Single Source of Truth” TMF to Avoiding Findings
  • Apply takeaway messages from multiple sponsor inspections by FDA, EMA, and MHRA
  • Consider lessons learned from the harmonization and merging of Sponsor/ CRO hybrid paper and electronic TMFs into a single, Sponsor eTMF
  • Discuss the implications of SSOT to how you work with CROs
  • Address challenges SSOT poses for data integrity
Michele Weitz, Senior Director, GCP Compliance Operations, CLOVIS ONCOLOGY
Case Study Align Technologies and Streamline Processes to Support the Ability of Cross-Functions to Work With Vendors
  • Work internally with IT and other partners to road map and implement your reform
  • Marry the world of business requirements with the world of regulations to ensure ICH and GxP compliance
  • Improve efficiency and improve by streamline process internally
  • Incorporate big data mapping and share data across functions to maximize partnerships
  • Enact thoughtful access management and plan training accordingly
Jennifer Arters, eClinical Manager eTMF and Collaboration, CSL BEHRING
Christopher M. McSpiritt, Director Consulting Services, CGI CONSULTING
Born to Be Contemporaneous: Road Mapping Your eTMF to Evolve Technology in Accord With Changing Passenger Need, Rules of the Road, and Road Conditions
  • Establish a system to routinely update and refine your systems
  • Determine business impact and resources by engaging engage multiple functions
  • Leverage end-user experience and input to streamline processes
  • Take account of the ramifications of proposed change to training
  • Enhance road map because of regulatory mandates or audit findings
  • Compare enhancements of various prioritization levels and classifications
  • Estimate the resources that will be necessary augment your system
  • Look at a case example of Daiichi Sankyo’s change control board’s role
Transition Time
Use Recent Trends to Effectively Prepare for Inspections
  • Discuss inspection trends and their implications for inspection preparation
  • Convey expectations for inspection-readiness activities
  • Explain best practices for inspection-preparation activities including risk based analysis to determine focused TMF review
  • Address some particular challenges related to TMF inspection preparation activities
Susan Groth, Associate Director, Headquarters Clinical Quality Management (HQ CQM), MERCK
Case Study Hear a Journey to TMF Compliance — A CT Supply Chain Functional Perspective Through Three Lenses (Quality, Business, and Cross- Functional Collaboration)
  • Discuss intersection of GCP, GDP, and GMP and comparing requirements and document types while linking back to DIA Reference Model
  • Drive cultural change within the function and develop new business processes using a riskbased and resource-aware approach
  • Partner with central TMF group and other supporting functions to ensure business process alignment while fostering understanding of unique challenges of clinical supply group
  • Explore next steps and continuous process improvements
Sonja Davis, QA Consultant, QA-Product Research and Development, ELI LILLY
Thomas Miller, Manager, Clinical Supply Planning and Execution, ELI LILLY
Minette Pugh, Advisor, Quality Systems and Compliance Management, ELI LILLY
Panel Explore the Impact, Prerequisites and Application of Emerging Technologies
  • Learn how different companies have applied automation, AI and machine learning
  • Outline capabilities, resources and other factors that must be in place
  • Look at the limiting factors, risks and challenges of technology
  • Explore the limitations and possibilities that technological advances afford and will afford
  • Utilize tips, techniques and tools to maximize benefits and minimize drawbacks

Perry Steinberg, Regulated Content Management, General Manager and Product Leader, MEDIDATA


Andy Chu, Director, Regulatory Affairs – Regulatory Systems Strategy, BIOGEN
Debra Wells, Manager, TMF and Compliance, EISAI
Robert Willis, Director, Merck Research Labs IT, Merck

Plenary Sessions | Conference Day Two | Thursday, January 24, 2019
Networking Luncheon
Sticker Program Drawing - Exhibition Hall

(You must be present to win.)

Panel The Future of eTMF: What Are the Key Change Enablers?
  • Interoperability — essential requirements for machine-to-machine exchange of TMF content
  • Traceability and data integrity (need for a redefinition of audit trail)
  • Inspection readiness and wider scope — the challenge of inspection of multiple electronic systems
  • Connecting the dots, challenges in the presentation of TMF information and ability to tell an accurate story
  • To TMF or not to TMF — need for more specific guidance from the regulators; potential ratification of the TMF RM by ICH?

Paul Fenton, President and CEO, MONTRIUM


Kathy Hijek, Associate Director, Clinical Operations, Duke Clinical Research Institute
Joy Mehlenbacher-Mohamed, Manager, Clinical Support and Quality Documentation, BOEHRINGER INGELHEIM

Panel Be Inspection-Ready Through CRO-Sponsor Collaboration to Create a Unified TMF
  • Improve internal and external processes through training and support
  • Discuss how the allocation of and process of allocating responsibilities should be improved
  • Hear insights into how a sponsor’s KPIs can better account for CRO’s own assessment systems
  • Listen to considerations (e.g. processes, QC, etc) and impediments to electronic ownership transfer that sponsors tend to overlook
  • Debate the upsides and downsides of using a sponsor’s eTMF vs. using a CRO’s eTMF
  • Get feedback and suggestions for governance strategies and oversight practices


Kristen Bretzius, Document Center Manager, PSI PHARMA SUPPORT AMERICA
Michelle Ingraham, Manager, Information Governance and Compliance, PPD
JP Miceli, Associate Director of Document Management, ADVANCED CLINICAL
Pat Miesner, Global Quality Manager, NOVELLA CLINICAL
Jelena Pavlovic, Senior Manager, Global CTA Management, PHARM-OLAM INTERNATIONAL

Panel Learn From Sites to Standardize Procedures, Provide Support and Develop Trainings
  • Provide empathetic/user-driven operations and protocols for site adherence
  • Hone the collection and management of Electronic Investigator Site Files (eISF)
  • Hear tactics for universal practices for the labeling and filing of documents
  • Prepare the site/sponsor teams along with the site/CRA/sponsor tools
  • Hear tactics and tips sites would recommend based on their stressors

Alana Wriggins, Head Site Management, NA, Acquisition Integration and Clinical Records Management, ALLERGAN


Amy Gunnett, Certified Clinical Research Coordinator, UNIVERSITY OF FLORIDA
Aryn Knight, Clinical Research Oversight Specialist; Assistant Administrative Director, TEXAS HEART INSTITUTE
Amy Lounsbury, Clinical Research Director, MN GASTROENTEROLOGY

Chairpersons' Closing Remarks
Summit Concludes

Conference Documentation Now Available

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