In a 2012 survey, 77% of clinical trial sites reported that manual methods were the primary tool being used for exchanging clinical trial documents. Although the inefficiencies of paper and the benefits of web-based tools are widely recognized, adoption of portals for investigator documents has been slow.
In this session, we will arm you with the knowledge you need to transition investigator site documents to an electronic system.
- The advantages of moving from a paper-based process to an electronic system
- Must-have and nice-to-have features in an electronic system
- Best practices for improving efficiency and quality control in document management
- The challenges of implementation
- Benefits for clinical trial sites
Speaker:
Sharon Ames
Enterprise Program Director
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 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, per 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.