(Recorded on January 29, 2013)

Implementing an electronic trial master file system in a global organization can be a challenge, especially when you must consider the nuances of country/regional eTMF management for many clients. In this session, Covance, one of the world’s largest contract research organizations, will share their perspective on managing an eTMF initiative. We’ll discuss timing, challenges, and strategies for successfully designing and implementing a system. By attending this webinar, you will learn best practices for managing change in a global, multi-functional organization while ensuring you deliver an audit-ready trial master file. We will also cover:

• Implementation team structure
• Process optimization
• Strategies for change management
• Approach to global training
• Vendor expectations
• Challenges, best practices, and lessons learned

Speakers
Jamie Toth
eTMF Business Lead & Associate Director, Clinical Development Services
Covance Inc.

Jamie Marie Toth, Associate Director at Covance, is currently the electronic Trial Master File (eTMF) Business Lead.

Ms. Toth has over 18 years of IT experience in the pharmaceutical industry and has been with Covance for 5 years. During her tenure at Covance, she has brought her passion for IT into the clinical business arena to transform the Information Services department and move all scientific and clinical journals from print to purely online. She was also integral in reshaping the feasibility business process and developing an in-house survey collection process. Ms. Toth is a Certified Project Manager (CPM) and a trained Six Sigma Green Belt.

Ms. Toth received her Bachelor of Arts in Business and Technology at Fairleigh Dickinson University and an Associates of Applied Sciences in Computer Systems & Technology at Mercer County Community College.

Sharon Ames
Enterprise Program Director
NextDocs Corporation

Sharon Ames, Enterprise Program Director at NextDocs Corporation, is responsible for strategic management of enterprise clients and thought leadership in the clinical market.

Ms. Ames offers over 25 years of clinical experience, with over 10 years in the CRO industry and 15 years of clinical site experience. Prior to joining NextDocs, Ms. Ames was the Global Director, Trial Master File management for INC Research. In this role, she was responsible for ensuring that global trial master files were maintained per ICH/GCP and national and local regulations. While at INC Research, Ms. Ames served as the business owner for the development and implementation of an internal eTMF system, investigator essential document collaboration portal, and CTMS integration. She also held director-level positions in site start-up activities, including site selection, investigator contracts, and essential document completion.

Ms. Ames received her Bachelor of Science in Dietetics at the University of Dayton and is a Registered Dietitian.