Electronic Trial Master File Forum
(East Coast)

Achieving Increased Efficiencies with Integrated Technology and eTMF User Engagement

October 20-21, 2020

East Brunswick, NJ

Event Overview

To improve life sciences organization's operations, the secure regulated cloud is vital for regulated clinical trial content and electronic trial master files are at the heart. As integrated technology permeates every aspect of pharmaceutical, biotech, and medical device clinical trial research it is vital to constantly improve the function of the data processing of your organization.

Attendees at this conference will learn best practices and actionable strategies for evaluating, implementing, and sourcing eTMF systems.  This event will touch upon eTMF user engagement, improving clinical data management, and achieving cost savings and workflow efficiencies. Faculty will present on eTMF regulatory requirements, eTMF internal audits/quality reviews to enhance inspection readiness, techniques for tracking and filing correspondence, and AI and machine learning. Take advantage of this opportunity to share best practices and network with thought leaders and decision-makers in the life sciences.

Hilton East Brunswick


3 Tower Center Blvd.
East Brunswick, NJ 08816

(732) 828-2000

Hotel Website

Advisory Board


Sholeh Ehdaivand
President and CEO
LMK Clinical Research Consulting

Sholeh is an internationally known TMF Subject Matter Expert with over 15 successful years of experience in the Clinical Research Industry. Her expertise and knowledge in all areas of study management and operational aspects of the clinical trial and document management processes has made her a leader and trusted expert. Her experience includes the TMF Reference Model Subject Matter Expert, eTMF management, domestic and international pharmaceutical and biological clinical trials, clinical trial management, site selection, vendor relations, electronic document management, regulatory submissions, quality control processes and implementation and regulatory inspection preparation and participation.

She is currently Principal Consultant and President and CEO of LMK Clinical Research. She is also the Facilitator for the Metrics Champion Consortium's (MCC) TMF initiative. In this role, she is leading a group of cross-functional experts to develop and implement TMF metrics and processes.

When Sholeh is not busy with LMK, she is active in her community participating in a number of charitable organizations including Make-A-Wish, Junior League of Charlotte and Jack and Jill of America.

LMK Clinical Research Consulting provides expert solutions and services in quality document management to the life sciences industry. They understand the importance of a detailed and accurate TMF as the foundation of clinical trials and offers comprehensive services including TMF implementation, review and remediation, quality control processes, audit and inspection preparation and support, development of workflow processes and personal training and consulting.

LMK is dedicated to their clients needs and accelerating the global development of safe and effective medical therapeutics.

LMK is certified as a woman-owned business by the Women's Business Enterprise National Council (WBENC). 

Top Reasons to Attend

  1. Optimize your organization’s TMF operations and improve inspection-readiness levels with tested, proven best practices
  2. Understand eTMF regulatory requirements and set up your eTMF to assure compliance from the first day
  3. Learn from industry professionals to manage organizational culture change, enhance user engagement, and lead cross-functional teams around an eTMF
  4. Hear eTMF document management strategies directly from leaders in clinical data management
  5. Discover the latest integrated technologies that allow all clinical partners (CRO, sponsor, sites, IRB’s and regulators) secure and global access to dispersed content 

Attendee Profile

This Conference is Designed for Life Science Professionals responsible for:

  • TMF/eTMF Operations/Management
  • eTMF Systems Integration
  • Quality Management Systems
  • Document Management
  • Digital Innovation
  • Clinical/Research Operations
  • Clinical Study Management
  • Clinical Research Management
  • Clinical Trial Compliance
  • Clinical Innovation
  • Clinical Trial Design
  • Clinical Project Management
  • Clinical Regulatory Affairs
  • Clinical Safety
  • Clinical Supply Chain
  • Protocol Design
  • Patient Engagement
  • Patient Experience
  • Patient Recruitment
  • Site Selection & Start Up
  • Investigations
  • Research Nursing
  • Quality Assurance
  • Quality Control
  • Safety Analysis
  • Information Systems Management
  • EClinical Technologies
  • Data Integration/Oversight
  • R & D
  • Risk Management
  • CRO Oversight
  • Outsourcing/Vendor Management
  • Cooperative Research Groups
  • Alliance Management
  • Medical Affairs
  • Medical Information
  • Report Writing
  • Biostatistics
  • Biotech Engineering
  • FDA Submissions
  • Strategic Operations
  • Tactical Planning
  • Corporate Legal Affairs
  • Corporate Financial Planning
  • eTMF Service Providers
  • QMS Service Providers
  • IT Service Providers
  • Clinical Trial Service Providers


October 20th, 2020 | Day 1

8:00 AM - 9:00 AM

Registration & Continental Breakfast

9:00 AM - 9:15 AM

Conference Opening Remarks

9:15 AM - 10:00 AM

Assessing and Measuring TMF Completeness

  • Execute truly integrated eTMF processes 
  • Applying real-time KPIs and metrics 
  • Generate and manage automated workflow to gain the edge 

Marie-Christine Poisson-Carvajal - Head of TMF and Registry

10:00 AM - 10:45 AM

Updating TMF Plan & Reference Model Aligning with SOP and Work Instructions

  • Effective approaches to revising your process documents
  • Making certain that the SOPs and WIs align
  • Creating efficient TMF reference model templates

Traci Wendler - TMF Study Lead Line Head
Bristol Myers Squibb

10:45 AM - 11:00 AM

Morning Networking Break

11:00 AM - 12:00 PM

How to Select an eTMF that Works Best for Your Organizations Needs

  • Successful strategies to transition to eTMF
  • Best practices for selecting, implementing and transitioning
  • Assuring compliance from day one
  • Action items that are typically neglected

Sholeh Ehdaivand - President and CEO
LMK Clinical Research Consulting

12:00 PM - 1:00 PM

Networking Lunch

1:00 PM - 1:45 PM

TMF Inspection Readiness

  • Implementing proactive versus reactive tactics for inspections
  • How will COVID-19 change your 2020 inspections

1:45 PM - 2:45 PM

Best Practices for Compliant eTMF Archiving

  • Structure contents of the TMF for accessibility, storage and quality
  • Address regulatory challenges facing archiving such as low data integrity, data immutability and retention periods
  • Learn methodologies to actively manage documents on an ongoing basis

2:45 PM - 3:00 PM

Afternoon Networking Break

3:00 PM - 4:00 PM

Moving Toward a Risk-based eTMF Operating Model

  • Build a true quality system around a solid framework that emphasizes completeness
  • Continually reevaluated decisions to ensure they are producing the desired outcome

Laura Naranjo - Associate Director, TMF Operations

4:00 PM - 4:45 PM

Collaborating with CRO’s Using Cooperative Procedures

  • Aligning processes for appropriately trained and metrics
  • Internal change management to build out the relationship successfully

4:45 PM - 5:00 PM

Day 1 Closing Remarks


October 21st, 2020 | Day 2

8:00 AM - 9:00 AM

Registration & Continental Breakfast

9:00 AM - 9:15 AM

Recap of Day 1 & Day 2 Opening Remarks

9:15 AM - 10:00 AM

Execute Truly Integrated eTMF Processes

  • Applying real-time KPIs and metrics 
  • Generate and manage automated workflow to gain the edge 

Maha Saad, Ph.D., MBA - Americas Pharmacovigilance Head, Bioresearch Quality and Compliance, Quality Assurance

10:00 AM - 10:45 AM

The Future of eTMF, and Culture Change Management

  • Hear where eTMF is headed and explore the new technologies to watch out for
  • Employ proven management principles    

Stephanie Viscomi - Associate Director, TMF Compliance and Education

10:45 AM - 11:00 AM

Morning Networking Break

11:00 AM - 12:00 PM

Using Electronic Software Suites to Automate Communication, Streamline Workflow, and Increase Efficiency

Alana Wriggins, BSN, MHS - Assoc. Vice President, Global Site Management Operations, TMF Operations, Compliance & Study Start Up

12:00 PM - 1:00 PM

Networking Lunch

1:00 PM - 1:45 PM

Regulatory Improvements for Remote TMF Access for Inspectors and Auditors

  • Identify threats to data integrity and compliance issues
  • Keeping Up to Date with EMA and ALCOA Guidelines

1:45 PM - 2:30 PM

Enhance Operational Productivity and Reduce Time to Study Milestone

  • Optimize your eTMF efficient and cutting clinical trial time resulting in higher ROI’s

2:30 PM - 2:45 PM

Afternoon Networking Break

2:45 PM - 3:45 PM

Effective Tracking and Filing of Correspondence

3:45 PM - 4:30 PM

AI, Machine Learning and Digital Tools for TMF Studies

  • Practical Applications in Clinical Operations for Today and Tomorrow
  • Embracing technologies in the eTMF space

4:30 PM - 4:45 PM

Day 2 Closing Remarks



Marie-Christine Poisson-Carvajal


Head of TMF & Registry


Stephanie Viscomi

Alexion Pharmaceuticals, Inc.

Associate Director, TMF Compliance and Education


Traci Wendler

Bristol Myers Squibb

TMF Study Lead Line Head


Laura Naranjo


Associate Director, TMF Operations


Alana Wriggins


Assoc. Vice President, Global Site Management Operations, TMF Operations, Compliance & Study Start Up


Maha Saad

Johnson & Johnson

Americas Pharmacovigilance Head, Bioresearch Quality and Compliance, Quality Assurance




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