New York Professional Events List

The 7th Trial Master File Summit (EXL)

Jan 16, 2018 - 08:00 AM - Jan 18, 05:30 PM
New York Media Technologies LLC
Hyatt Regency Grand Cypress1 Grand Cypress BoulevardOrlando, FL 32836United States,

FL ,
ZIP: 32836


A TMF is more than a living archive of a clinical trial’s progress; it is a system required by regulatory authorities and is critical for clinical oversight. By developing, implementing and utilizing a sound TMF plan, you will be able to monitor a trial as it advances, ensure high-quality documents and prepare your organization for an inspection at any stage. Additionally, by creating a TMF process, the clinical trial’s sponsors, CRO and site will be able to demonstrate their continued adherence to GCP during the trial.

At the 7th Trial Master File Summit, 40+ speakers will share best practices on a wide range of topics including:

  • Quality TMF improvement
  • System migration and eTMF implementation.
  • Determining and Managing Relevant communications in the TMF.
  • Completeness review by the study team and how to streamline this process.
  • Maintaining a real time TMF/Implementing Processes to maintain a real time eTMF.
  • Senior Management acceptance/funding/championing of eTMF implementation.
  • Metrics with CRO and internal staff.
  • How to construct a successful TMF team.
  • Involving functions in TMF.
  • Relevant correspondence, working with CRO partners, Inspection Readiness.
  • Document management and processes.
  • TMF QC or TMF Process Implementation.
  • Inspection Readiness, Metrics, Sponsor Oversight Responsibilities.
  • Nothing specific at this time.
  • CRO's and their SOP's and standards.
  • Study Close-out/Transfer.
  • How to set up a successful TMF staff. How to reduce the number of correspondence by downsizing the number of emails.

Top Five Reasons to Attend

  1. Learn from case studies and best practices for designing and implementing a TMF plan for global trials and inspectional readiness.
  2. Networking and learn with over 250 TMF colleagues.
  3. Hear updates on the DIA reference model and MCC’s metrics working group.
  4. Develop a TMF strategy to ensure proper TMF oversight.
  5. Explore the latest trends, preparations and expectations for TMF inspections from the FDA, EMA, MHRA and PMDA.

Who Should Attend

This conference is designed for representatives from pharmaceutical, biotech, medical device and clinical research companies with responsibilities in the following areas:

  • TMF and eTMF Management
  • Clinical Document/Data Management
  • Clinical Trial Administration
  • Clinical Operations
  • Regulatory Affairs/Operations
  • Trial, Document and Record Management
  • Clinical Document Coordination
  • Clinical Development/Study Management
  • Quality Assurance/Control/Operations
  • Competency Development
  • Strategic Operations and Planning
  • Quality Management
  • Informatics
  • Clinical IT

This event is also of interest to:

  • eTMF Service Providers
  • Data/Records Management Vendors
  • Clinical Research Organizations
  • Paper and Electronic Archiving Solution Providers



Pre-Conference TMF Training Day | Tuesday, January 16, 2018 7:30AM

Registration and Continental Breakfast Begin



The management of the Trial Master File, the content created in support of a clinical study, doesn’t have to be complicated. It can be as easy as 1-2-3 if a pragmatic approach is taken. The first step is to know what exactly is the TMF and define what is in “it.” The next step is to associate the TMF content in all its forms to its Owners. The last step is to establish process to ensure the TMF is inspection-ready at all times. Included in this workshop will be the presentation of typical problems incurred by companies establishing the TMF and its associated management processes. Audience feedback will be sought for the sharing of ideas to overcoming the challenges.

This workshop is geared towards those who are new to the TMF field, though all levels of experience can benefit from attending. Concepts addressed will allow the attendee to build/expand their foundation so they then can get the most out of the remainder of the Summit. Experienced workshop leaders will present as well as lead attendees through exercises that incorporate solutions to challenges that TMF professionals face. The workshop will address the following:

  • Using the TMF Reference Model to outline what’s in the TMF, and who owns the content
  • Review of the industry accepted requirements for management by those that create, collect, and also manage the TMF
  • Guidances, laws, and regulations that define and govern the TMF in the U.S., EU, and Japan
  • Typical problems faced and corresponding solutions

Louise HawkinsClinical Operations ManagerAGIOS 
Lisa MulcahyOwner and Principal ConsultantMULCAHY CONSULTING


Breakfast Workshop Concludes



If you are tasked with establishing the TMF management process at your company, you know that the end goal of having an inspection-ready TMF on an ongoing basis doesn’t just magically happen after the TMF management process is created and made effective. The work involved with successfully convincing into action and compliance 10, 15, 20 different functional groups to follow the defined processes is not small. Any success experienced does not come without a significant amount of assistance and oversight of the process by the TMF management team to ensure it is being followed according to expectations.

This seminar will be conducted using a carousel approach. Every group will have the opportunity to address a TMF challenge in timed segments. All groups will summarize the how they interpret the challenge and propose known working potential quick wins and long-term solutions for success based on their group members’ experiences.

  • Attendee-chosen challenges regarding the operationalizing of the TMF management process will be discussed with corresponding solutions proposed
  • An overview of the methodology for engaging people to be part of the solution instead of the problem will be provided

Lisa MulcahyOwner and Principal ConsultantMULCAHY CONSULTING 
Supriya ShoroffAssociate Director, TMFSAGE THERAPEUTICS


Seminar Concludes



The TMF Management Plan is a document that outlines the management of the TMF for a study. Standard industry practice dictates that a TMF Management Plan be created for each clinical study. However, the topics addressed within the TMF Management Plan can vary widely from company to company. The MHRA has provided an outline of topics important for inclusion in the plan and industry has identified additional ones based on best practices.

This workshop will review the expectations and best practices for topics to include in the TMF Management Plan. A few of the more complicated topics including expectations for quality reviews will be discussed in detail through small group exercises. Approaches for how, when, who and what will be presented by sponsor representative as well as the management of the outcome of the quality review and evidence of this conduct. This workshop promises a lively discussion that all attendees will benefit from; even those new to the TMF management field of work. Topics that will be addressed during this workshop are:

  • The TMF Management Plan in the eyes of the health authority representative
  • Why the TMF Management Plan is so crucial to the overall TMF management process
  • Definition of what is a quality review, how often one is to occur, tools used to conduct a quality review, and the evidence created as a result of the activity

Lisa MulcahyOwner and Principal ConsultantMULCAHY CONSULTING 
Jamie TothHead of TMF OperationsDAIICHI SANKYO

8:00PM Dinner Workshop Concludes

Conference Day One, Plenary Sessions | Wednesday, January 17, 2018 12:00AM

Registration and Continental Breakfast Begin


Summit Chairpersons’ Opening Remarks
Marie-Christine Poisson-CarvajalTMF Operations LeadPFIZER 
Karen RoySenior Vice President, Client SolutionsPHLEXGLOBAL 
Jamie TothHead of TMF OperationsDAIICHI SANKYO


Begin and Maintain a Continuously Inspection-Ready TMF Based on ICH GCP E6(R2) and Other Impending Updates
  • Get regulatory updates and discuss the anticipated impact of GCP E6(R2)
  • Implement a governance process that will cover the full life cycle of the TMF
  • Pinpoint the critical components of keeping a TMF ready for inspection
  • Utilize an information architecture system to ensure high-quality documentation
  • Incorporate efficient SOPs to integrate the TMF across all partners


Case Study Focus on Quality by Conducting a Comprehensive TMF Review
  • Ensure that the TMF specifications account for the protocol and design specifications, study operational components and events
  • Improve TMF quality by analyzing the interrelationships of documents
  • Achieve risk-based QC through a holistic approach and a comprehensive review of documents individually and collectively to ensure content quality
  • Perform a comprehensive TMF Content Review to be inspection-ready by performing logical checks
  • Review documents as they related to each other, reconcile filing/indexing issues and identify gaps
  • Improve TMF quality by analyzing the systemic connections of your study to your TMF

Marie-Christine Poisson-CarvajalTMF Operations LeadPFIZER


Session By:
Sharon AmesDirector, Client SolutionsPHLEXGLOBAL & RHO


Networking Break


Presentation by VEEVA SYSTEMS


Ensure Inspection Readiness From the Beginning
  • Build and develop a team according to trial demands of the trail and third-party needs
  • Determine set checkpoints for the life cycle of the trial
  • Set up your TMF before the start of the trial
  • Establish clear expectations and providing adequate and impactful coaching and training
  • Examine common impediments to inspection readiness of TMF and eTMF resulting from M&A

Alana WrigginsHead Site Management, North America, Global Site Management OperationsALLERGAN


Create Effective QC Process for Documents in Electronic and Paper Formats
  • Establish a process to assess and improve quality assurance practices
  • Vet tactics for meeting quality requirements when rolling out an eTMF system
  • Discuss tools and processes for TMF assessment
  • Conduct quality checks and expected versus missing documents

Wendy TrimboliHead of TMF Process Management and QCEISAI


Ensure GCP and Harmonization by Bringing Your TMF In-House
  • Discover why this is a growing trend and the circumstances that make this advantageous
  • Discuss case examples of migrations would take place
  • Avoid non-noncompliance issues and through QC
  • What happens to eTMF/eTMF data in third-party system and how do you extract artifacts and emails?
  • Discuss site oversight and management considerations
  • Identify threats to compliance and data integrity
  • What to do when you think you are done

Jackie MorrillDirector of Clinical OperationsLMK CLINICAL RESEARCH CONSULTING

1:00PM Luncheon

Conference Day One, Tracked Sessions | Wednesday, January 17, 2018 

eTMF Implementation 

Metrics and Tools 


Case Study Survey the Triumphs and Challenges of a Large-Scale eTMF Implementation on a Short Timeline
  • Glean lessons from GSK's experience transitioning to the TMF Reference Model
  • Study strategy for R&D-wide implementation from leveraging early adopters to full rollout
  • Look at governance best practices and processes and avoid pitfalls
  • Discuss impediments for implementation and the tactical ways that GSK coped with them
  • Aspire for continuous improvement and sustainability

Mike CzaplickiClinical Documentation Operations ManagerGSK
Oversee and Manage Vendors to Ensure Inspection Readiness With Standard Metrics
  • Engage vendors and internal stakeholders to ensure inspection readiness
  • Manage vendor/stakeholder performance and process improvement
  • Improve collaboration using strategic standards and KPIs
  • Align objectives, strategy and relationships

Wendy KellyManager, Global DevelopmentSUNOVION


Improve Your TMF Process by Creating a Collaborative Culture That Empowers Teams
  • Leverage the experience of your team on the ground to identify priority improvements
  • Invest in your team to build commitment and improve TMF and inspection-readiness expertise
  • Reward individual and team accomplishments with meaningful project and process ownership
  • Promote a culture of interdependence and shared success while driving improvement across the clinical study life cycle

Eric RubinsonFormer Executive Director, Clinical Records ManagementALLERGAN
Panel Use Metrics and Benchmarks to Improve TMF Management
  • Conduct and orchestrate activities by leveraging how quality metrics
  • Leverage metrics to improve the process and engage CROs’ investment
  • Identify the right set of TMF metrics for your organization
  • Study the impact of stakeholder oversight and metrics when a TMF is managed by a sponsor versus a CRO
  • Compare challenges faced by smaller and larger companies


Allison GrosikSenior Associate, TMF Management and ComplianceEISAI 
Tyler PraterClinical Trial ManagementELI LILLY


Networking Break


Panel Establish Milestones for Piloting, Implementing and Executing a TMF System
  • Address the scope of the eTMF and define graduations of eTMF and TMF maturity
  • Implement a pilot and ramp up phases while having a parallel paper and electronic version of the TMF
  • Discuss strategies for propelling your organization along the TMF continuum
  • Leverage industry benchmarks to drive process improvement


JP MiceliAssociate Director, Clinical Document ManagementSHIRE

Case Study Meet Business Imperatives and eTMF Requirements by Configuring an eTMF System
  • Ensure that functional leads perceive and can use the TMF as an ongoing study tool
  • Account for business process needs through a suitable eTMF configuration
  • Study how eTMF at Regeneron is used as an ongoing study tool

Jason WeinsteinBusiness Lead for eTMFREGENERON


Case Study Hear AbbVie’s Business System Operation Support (BSOS) — Experience Implementing and Ramping up an eTMF System
  • Design and implement “Authorization to Release” tools
  • Provide necessary training and support for all users
  • Listen to best practices for Full Document Processing
  • Discuss challenges of moving from seven studies to using eTMF for “all” studies within AbbVie in 3 years!

Susan Boyer YoungBusiness Systems Operation SupportABBVIE
Case Study Enhance Quality and Improve Inspection Readiness by Supporting and Allying With Internal Partners for In-House Studies
  • Survey the roadmap of your study to determine what tools and measurements you will need
  • Evaluate the health of your TMF using strategic metrics to measure select (i.e. the most critical) facets of your TMF
  • Inspect a process of customizing a tool to conduct a milestones review
  • Reallocate or redirect resources to better collaborate with different functions
  • Compare and contrast the contents of Master Allergan’s TMF Archive Directory of Record tool for disparate studies
  • Look at one TMF team's evolution over time in terms of composition and attributes

Renee FateDirector, Clinical Records ManagementALLERGAN

5:00PM Networking Reception

6:00PM Day One Concludes


Conference Day Two | Thursday, January 18, 2018 





Registration and Continental Breakfast Begin


Co-Chair’s Recap Day One
Karen RoySenior Vice President, Client SolutionsPHLEXGLOBAL
Co-Chair’s Recap Day One
Marie-Christine Poisson-CarvajalTMF Operations LeadPFIZER
Co-Chair’s Recap Day One
Jamie TothHead of TMF OperationsDAIICHI SANKYO


Use Software Development Methodology to Maintain Quality in Your TMF
  • Apply lessons from software development methodologies (e.g., agile, lean software) to address TMF concerns
    • Adherence to TMF standards
    • Audit readiness
    • Process improvement

Terri BakerDirector, Professional ServicesWINGSPAN TECHNOLOGY, a QuintilesIMS Company
Panel Monitor eTMF Completeness and Compliance
  • Utilize metrics to ensure a high-quality TMF is maintained
  • Determine and communicate benchmarks for meeting GCP standards
  • Hear how various companies ensure eTMF quality
  • Leverage quality metrics to conduct/orchestrate activities
  • Compare and contrast the process and criteria for determining solutions
  • Use shared metrics for your eTMF to drive improve collaboration and help organizations gauge their own performance

Ensure Compliance With Proof of Oversight Requirements of GCP R2 by Selecting CROs by Evaluating Their Abilities and Discerning Their Suitability
  • Determine telling and relevant measurements to assess risk to Quality and Compliance​
  • Evaluate customer service aptitude by asking the right questions and scrutinizing answers
  • Distinguish red flags from deal breakers and discuss suitable precautions/ remedies
  • Consider risk factors when selecting a specific CRO
  • Determine effective metrics for evaluating the performance of the supplier

Lori J. RidgeClinical Project Associate Lead, Critical Document Analyst, eTMF Oversight ExpertMYLAN


Case Study Maintain Consistency Through M&A and Other Transitions
  • Recognize the possible impact of changes (e.g., M&A, leadership change, etc.) on quality
  • Create and implement comprehensive transition plans
  • Manage internal organization and policy changes

Brenda BrownTMF Observation LeadPFIZER
Case Study Discuss Inspection Readiness at Amgen
  • Conduct audits and address issues that arise based on what inspectors are looking for
  • Build a compliance group to lead inspections
  • Ensure GCP with active roles and controls in place
  • Examine processes for efficiency and assess their impact

Andrew WaiteDirector, Records and Information ManagementAMGEN
Panel Learn From Sites to Inform and Standardize Procedures, Provide Support and Develop Trainings
  • Provide empathetic/user-driven operations and protocols for site adherence and fidelity
  • Hear tactics for universal practices for the labeling and filing of documents
  • Prepare the site/sponsor teams along with the site/CRA/sponsor tools
  • Discuss how ICH (R2) guidelines could impact how you work with sites
  • Enhance the collection and management of Electronic Investigator Site Files (eISF) documents
  • Hear tactics and tips sites would recommend based on their stressors


Alana WrigginsHead Site Management, North America, Global Site Management OperationsALLERGAN






Set up a Successful TMF Staff
  • Rank characteristics to search for when hiring a Document Specialist.
  • Institute an Individual Development Plan program from beginning/training to autonomy
  • Harmonize TMF staff using Six Sigma tool (MSA)
  • TMF Staff management: motivating your staff
  • Discuss advantages and disadvantages of regional staff or local staff

Catharine EspanholLATAM eTMF CoordinatorBOEHRINGER INGELHEIM 
Fabio RodriguesHead of eTMF in LATAM and Clinical Operations ManagerBOEHRINGER INGELHEIM BRAZIL
Overcome Pain Points and Maintain Inspection Readiness Through Document Processing Improvements, Collection Oversight and Rolling Audits
  • Survey TMF document collection trends
  • Effect continuous collection improvements through KPI’s
  • Conduct rolling audit review of your eTMF
  • Achieve collaboration with your TMF partners
  • Discuss tactics for document mitigation

James PetersDirector of Professional ServicesDATA REDUCTION SYSTEMS CORPORATION
Case Study Work Effectively With CROs to Create a Unified TMF Process and Maintain Inspection Readiness
  • Discuss Alkermes’ consistency-driven oversight strategy for CROs and its impact on consistency
  • Institute avenues for two-way communication and collaboration among internal functions and CROs
  • Communicate expectations and support internal and external stakeholders
  • Improve internal and external processes through training and support
  • Discuss the lessons learned from working with a broad array of CROs of disparate cultures and needs​

Kate SantoroClinical Trial Manager, Clinical Systems and DocumentationALKERMES


Panel Coordinate to Collaborate: How CROs and Sites Can Become Partners
  • Vet CROs using poignant and objective criteria and evaluate their risk quotient and partner suitability
  • Determine telling and relevant measurements to assess risk to quality and compliance
  • Ascertain capability by adapting a rating system for cultural fit and aptitudes
  • Evaluate customer service aptitude by asking the right questions and scrutinizing answers
  • Explore the advantages of KPI-driven partnerships


Joanne MaliaAssociate Director, Clinical Documentation ManagementREGENERON

Panel Compare the Merits and Drawbacks of eTMF vs Email Communication
  • Avoid findings from MHRA, EMA, and the FDA when they are checking correspondence in your eTMF
  • Organize emails into topics in your eTMF and prioritize email correspondence
  • Turn email into a productivity ally and not a time waster
  • Hear tips and etiquette that can help you in the use of emails

Maintain Consistency Through Mergers and Acquisitions and Other Transformations and Transitions at CROs
  • Create and implement comprehensive transition plans
  • Manage internal organization and policy changes
  • Develop a communication plan suited to relating to the various internal departments and external partners with disparate needs
  • Maintain continuity throughout


Effect eTMF Quality by Providing Essential Training and Support
  • Communicate, clarify, and uphold expectations for sponsor and CRO eTMF user
  • Conduct performance-based training simulations in person and remotely
  • Explore metrics for user performance assessments and thresholds for interventions or additional training
  • Survey various training tools and how they are customized
  • Execute validations and make necessary changes to script
  • Partner with HR to ensure that suitable candidates are selected based on informed criteria

Dina AntonacciClinical Training and Systems ManagerMALLINCKRODT
Fortify Quality Control With an Inspection-Ready Mindset for TMF Quality Assurance
  • Highlight the instrumental practices for instilling and inspection-ready mindset
  • Solve problems in your organization via a multidisciplinary approach
  • Communicate QC reasoning and standards to ensure compliant document filing and maintenance sponsor companies
  • Provide comprehensive feedback to TMF users
  • Standardize metadata and examine your improved workflow
  • Use systems to their potential for efficient retrieval of inspection documents

Evelin BaezClinical Document Management SpecialistCR BARD
Determine the Degree of Correlation or Dissociation of ​eSignatures ​to Essential Documents​
  • Discuss the trends in the ​adoption and​ use of eSignatures by ​sponsors, CROs and​ ​​sites
  • Prepare for​ ​inspection of eSignatures and ​​disse​ct ​the technology that enables them
  • Examine the impact of new regulations and guidance on essential documents and regulated content management systems
  • ​Discover and compare variations in technology models, from the Chevy to the Cadillac

Betsy FallenSpecial Topics ConsultantSAFE-BIOPHARMA ASSOCIATION




Advance Your Inspection Readiness With Analysis of Trends Trending for Effective Oversight of CRO TMF Management
  • Evaluat​e​ of TMF for inspection readiness using customized tools
  • Extract​ ​metrics and prioritization of corrective action
  • Analyze to determine trends for process improvement and development
  • ​Consider the impact of new or pending regulations on TMF management

Mark ChoeTMF Quality Management and Inspection Readiness ConsultantDAIICHI SANKYO


Prepare for a TMF Inspection — Follow the Trends and Remain Compliant
  • Evaluate​e​ of TMF for inspection readiness using customized tools
  • Extract​ ​metrics and prioritization of corrective action
  • Analyze to determine trends for process improvement and development
  • ​Consider the impact of new or pending regulations on TMF management

Laura NaranjoTMF Operations, Clinical Development Operations FunctionDAIICHI SANKYO




Manage Email Correspondence Within the Trial Master File
  • Address what email correspondences need to be put within the TMF
  • Learn how to file a large number of emails sent between sponsors, CROs and investigators
  • Develop strategies and guidances for filing emails
  • Utilize technology to enhance and integrate filing within an eTMF
  • Explore best practices for handling email attachments


Case Study Holistic Approach for Achieving Quality – Inspection Ready TMFs
  • Discuss the impact of ICH E6 (R2) on TMF quality and quantity
  • Identify strategies to evaluate and mitigate TMF compliance risks
  • Establish quality standards, metrics and tools to keep TMFs accurate and current
  • Identify and limit risk in accordance with common inspection findings
  • Minimize risk through effective change management and education

Jennifer PoulakosDirector, Development Quality AssuranceAGENSYS, an affiliate of ASTELLAS


Conference Concludes

Speaker Details


Sharon Ames

Director, Client Solutions 

Dina Antonacci

Clinical Training and Systems Manager


Melissa Asare-Aboagye

Systems Administrator, Developmental Sciences Quality

Evelin Baez

Clinical Document Management Specialist 

Terri Baker

Director, Professional Services 

Brenda Brown

TMF Observation Lead 

Mark Choe

TMF Quality Management and Inspection Readiness Consultant 

Kathie Clark

Vice President, Product Management 

Mike Czaplicki

Clinical Documentation Operations Manager 

Martina Duevel

Senior Global Clinical Project Manager

Sholeh Ehdaivand

President and CEO 

Catharine Espanhol

LATAM eTMF Coordinator 

Betsy Fallen

Special Topics Consultant 

Renee Fate

Director, Clinical Records Management 

Janice Fletcher

Senior TMF Project Manager

Allison Grosik

Senior Associate, TMF Management and Compliance 

Louise Hawkins

Clinical Operations Manager 

Wendy Kelly

Manager, Global Development

Aryn Knight

Clinical Research Oversight Specialist

Lee Ann Lawson

Project Manager: Translational Research, College of Medicine

Amy Lounsbury


Joanne Malia

Associate Director, Clinical Documentation Management 

Alex Markiel

Associate Director, Developmental Sciences Quality

Colleen Maude

Director, Trial Master File

JP Miceli

Associate Director, Clinical Document Management 

Jason Methia

VP, Vault Clinical, Enterprise

Jackie Morrill

Director of Clinical Operations 

Lisa Mulcahy

Owner and Principal Consultant 

Laura Naranjo

TMF Operations, Clinical Development Operations Function 

Dawn M. Niccum

Director, Quality Assurance

James Peters

Director of Professional Services 

Marie-Christine Poisson-Carvajal

TMF Operations Lead 

Jennifer Poulakos

Director, Development Quality Assurance 
AGENSYS, an affiliate of ASTELLAS

Tyler Prater

Clinical Trial Management 

Lori J. Ridge

Clinical Project Associate Lead, Critical Document Analyst, eTMF Oversight Expert 

Kelley Robinson

Repository Management Lead, Content Management and Authoring

Fabio Rodrigues

Head of eTMF in LATAM and Clinical Operations Manager 

Karen Roy

Senior Vice President, Client Solutions 

Eric Rubinson

Former Executive Director, Clinical Records Management 

Kate Santoro

Clinical Trial Manager, Clinical Systems and Documentation 

Supriya Shoroff

Associate Director, TMF 

Please contact the event manager Marilyn below for the following: 
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)
You can also contact us if you require a visa invitation letter, after ticket purchase. 
We can also provide a certificate of completion for this event if required.

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