Birds-of-a-Feather Discussion: ICH-E6 (R2) and Industry Adoption of RBM
Date: Tuesday, June 19th Duration: one hour
Presenters: Abby Abraham and Ken Light, OmniComm Systems
Open To: Staff from eClinical Forum member companies (If you are not an eCF member, please review our website www.eclinicalforum.org for membership information or contact firstname.lastname@example.org ) eCF Members: Please send an email to email@example.com for access information.
Background: eClinical Forum Birds-of-a-Feather sessions focus on the details of a specific topic. All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis. The facilitator will [try to] keep the subject on track and prompt discussion and information sharing.
For This Topic:
Given the recent ICH-E6 (R2) regulatory directives, OmniComm Systems, in partnership with eCF, is sponsoring an industry-wide survey to capture the current adoption baseline of ICH-E6(R2) and RBM. This survey seeks to understand the following in the industry across organizational size, type and regions:
- Outlook and strategic direction of organizational implementation of RBM
- Practices and adoption trends from operational perspective across different strata and regions in the industry.
- Optimizing the implementation through technology is critical to implementing modified processes and yields scalability in the long run. Current state and trends in utilization of technology.
- Current challenges to implementing RBM
Gathering information on this important topic is a several-step process. First we will have group discussions via “Birds-of-a-Feather” sessions using the survey questions to spark discussion. The survey will be sent to all eCF members as well as throughout the industry and results of the survey will be summarized and presented back at future eCF and industry meetings.
Participants are encouraged to share their ideas and experiences during the BoF sessions!!