An inclusive approach to the challenges of implementing eSource projects in regulated research

By April 1, 2016 Blog No Comments
Lab Experiment

Regulated Research of eSource Projects

In appreciation of contributions to the industry and insight on interoperability solutions, Adaptive Clinical was pleased to be invited to the eSource Stakeholders Group Meeting held on March 18th, 2016 in Silver Springs Maryland.

The purpose of the meeting was to take an inclusive approach to the challenges of implementing eSource projects in regulated research, and to inform the diverse group of stakeholders with best practices for future efforts.
As part of the meeting, five working groups were established:

  • Provenance (Data, Process) Chain of custody of data through the systems
  • eCRF (Concept and Implementation)
  • System Validation / Privacy
  • Economics – Cost/ Benefit
  • Scalability Requirements (Technology as well as Regulations and Political issues)

In-depth discussions focused on topics surrounding operational experiences and successes, including:

  • Producing specific deliverables with increased quality
  • Optimizing communication efforts between all parties
  • Thinking globally while acting locally

There was a significant presence from the FDA who spoke on the complexity of eSource and the systems involved, as well as the challenges around addressing different standards. Attendees were encouraged to receive confirmation from the FDA’s position on how middle-ware tools, such as the Adaptive eClinical Bus®, can serve as the bridge between systems and compliance.

Adaptive Clinical Systems is committed to the success and growth of this eSource Working Group, and was grateful to contribute to the discussion on how best to support and move the industry forward.