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The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.


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Birds-of-a-Feather Discussion:  ICH-E6 (R2) and Industry Adoption of RBM

19-June-2018 via webinar (one hour)

Event date: 6/19/2018 Export event

Birds-of-a-Feather Discussion:  ICH-E6 (R2) and Industry Adoption of RBM

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 info@eclinicalforum.org )   eCF Members: Please send an email to suzanne.bishop@eclinicalforum.org 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:

  1. Outlook and strategic direction of organizational implementation of RBM
  2. Practices and adoption trends from operational perspective across different strata and regions in the industry.
  3. 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.
  4. 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!!

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Birds-of-a-Feather Round-Table Webinar Discussion: Subject Status Calculations

Facilitator: Lisa Jones-Moore, Clinical Systems & Supplies Planning, Eli Lilly & Co.

This is a round-table discussion and participants are encouraged to share their experiences, ideas and questions on this topic.

The following questions will be discussed:

  • How many subject/patient dispositions do you collect (i.e. Subject completed treatment and follow-up, Subject discontinued treatment and dropped follow-up, Subject discontinued treatment and completed follow-up, etc.)
  • How does subject status get updated in your clinical trial management system?  Automated calculation using a datahub or manual update by monitoring or other personnel?
  • Is monitoring done internally or is there a third party organization performing this task?  If TPO, do they use their own system or your system?  If they use their own system, how does the data get back into your system?
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4/30/2020 UTC
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Birds-of-a-Feather Webinar: Tufts-eClinical Solutions "Data Strategy and Transformation Study Results"

eClinical Solutions, a member of the eClinical Forum, has collaborated with the Tufts Center for the Study of Drug Development in 2019 to survey pharmaceutical companies about their evolving clinical data demands and the tactics they are employing to manage and leverage their data. Highlights reveal new strategies and digital transformation initiatives being taken. This webinar will share key results from the survey as well as insights and opportunities to use this data to further clinical data architectures. 

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