Online Livestream
Electronic Trial Master FileForum
Achieving Increased Efficiencies with Integrated Technology and User Engagement
Event Overview

To improve life sciences organization’s operations, the quest for reduced cycle times, acceleration, quality, technology is one of the pillars for success. Data and records management is essential to demonstrate integrity, reliability, and compliance. Pharmaceutical companies, CROs, institutions, investigational sites, research centers developing drugs or devices must adapt to a business and regulatory environment that is rapidly changing and evolving. Technical solutions are the new norm and like any other domain records management should adopt electronic solutions for efficient management of the documentation generated during the life cycle of clinical trials.

Attendees at this conference will learn best practices and actionable strategies for evaluating, implementing, and sourcing eTMF systems.  This event will touch upon user engagement, improving clinical data management, and workflow efficiencies. Faculty will present on TMF 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 with thought leaders in the TMF space.

Event Sponsors
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Featured Speakers
Alana Wriggins, BSN, MHS
Assoc. Vice President, Global Site Management Operations, TMF Operations, Compliance & Study Start Up Formally
Carolyn DeVivo
eTMF Manager
Xeris Pharmaceuticals, Inc.
Christine Beshay
TMF Study Lead, Global Trial Master File Process, Global Clinical Operations
Bristol Myers Squibb
Christopher Michael
GCP Archivist
This is a short bio section
Gordon D. Bedford
Regulatory Documentation Specialist
Evelo Biosciences <br /> Other Company
Jason D King-Andreini
Sr Manager, TMF Operations
Jason Weintstein
Manager eTMF
Regeneron Pharmaceuticals
Keith Win
Business Analyst, TMF Operations
Daiichi Sankyo, Inc.
Marie-Christine Poisson-Carvajal
Head of TMF and Registry
Mary Emanoil
Senior Director, Authoring and Workflow Business Solutions Information Management
Paula Carol Federline
TMF Coordinator
Chimerix Inc.
Richard Golden
TMF Analyst
Glaxo SmithKline
Ronla Prince
Manager, Document & Unified Clinical Systems
Saurabh Kothari
Director, Regulatory Affairs
Evelo Biosciences
Sholeh Ehdaivand
President and CEO
Stephanie Viscomi
Associate Director, TMF Operations
Traci Wendler
TMF Study Lead Line Head
Bristol Myers Squibb
Event Schedule
  • Define end-to-end process and controls using quality by design and risk-based principles
  • From business case to technical solutions and roadmap, identify key steps and components
  • Define TMF operational model, roles and ensure user engagement
  • Effective revision of your process documents
  • Certify that the SOPs and WIs align
  • Create efficient TMF reference model templates
  • Apply real-time KPIs and metrics to determine the health of your eTMF
  • Generate and manage automated workflow to reduce manual effort and obtain key insights
  • Take advantage of the full capabilities of the platform you adopt
  • Change management for long term TMF culture transformation
  • How to achieve a positive TMF culture change with many completing complexities
  • Renew TMF to improve processes
  • Evaluate and understand the needs to transition to eTMF
  • Define the requirements and controls and articulate the ROI
  • Best practices to prepare for the RFP process
  • Execute truly integrated TMF plan to support your TMF process
  • Generate and manage automated workflow to gain the edge 
  • Ongoing cross checks practices to ensure completeness throughout the TMF
  • Identify threats to data integrity and compliance issues
  • Keep Up to Date with EMA and ALCOA Guidelines
  • Strategies to maintain processes in real-time as the TMF is being generated
  • Successful strategies to create CRO partnerships that last
  • Build out relationships with internal change management
  • Techniques to develop clear expectations before during and until TMF transfer to the Sponsor
  • Optimize your eTMF efficiency 
  • Demonstrate vendor oversight while also undertaking routine system maintenance activities
  • Think ahead: seamless execution of large-scale clinical trials with respect to TMF access and document management
  • What is periodic review and why is it important to your TMF
  • When and how is periodic review conducted
  • Periodic review for inspection readiness and archiving
  • Introduction and Definition of GDP according to ICH guidelines
  • Recognize the importance of methodical and organized documentation in research
  • Some challenges while filing in TMF
  • GDP and maintaining TMF compliant and complete
  • Structure contents for accessibility, storage and quality for successful eTMF archiving
  • Address regulatory challenges facing archiving such as low data integrity, data immutability and retention periods
  • Learn methodologies to digitally preserve and actively manage documents on an ongoing basis
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