In an interview at the 2023 DPHARM conference with ACT editor, Andy Studna, Amy Cramer, steering committee board co-chair, HL7 FHIR Accelerator Vulcan gives an overview of Vulcan and how it is working with the global research community to solve challenges in clinical trials.
Cramer: Vulcan is a Health Level 7 (HL7) FHIR which is a type of standard: fast healthcare interoperability resources accelerator dedicated to both translational and clinical research. What really excites me about Vulcan is the makeup of the members of Vulcan. it is intended to include the research community: patient advocacy groups, large vendors to small individual people in their garage working, academic sites, small sites, pharma, EHR vendors; it's meant to bring everybody together to work on these problems and by doing that what we do is we don't wind up creating a solution that creates a bottleneck somewhere else and also my hope is that we're starting to allow for adoption of the solution because we built it together as a group. There's a lot of really amazing projects that are coming out of Vulcan. We have already moved forward with several implementation guides that are now standards. One that really has been resonating and getting a lot of exposure is the Gravitate Health e-labeling implementation guide and that's getting not only traction within Europe where that project originated but across the entire globe. I think that really set us up as an organization to be ready to handle those types of global projects because we are a global industry and so we are very excited that the ICH is asking Vulcan to convene the technical specifications for the protocol digitization and there will be other parties that will obviously be a part of that, CDISC included. And that's really exciting. I love that opportunity to convene the different groups of people together so that we come up with a solution that we can all adopt and move forward. And let's be honest, protocol digitization, that's a game changer.
2025 DIA Annual Meeting: Why AI and Automation Are Set to Become the New Normal in Clinical Research
June 20th 2025Peter Ronco, CEO, Emmes, shares his long-term vision for artificial intelligence in clinical research, from making automation routine to improving drug discovery, transforming regulatory oversight, reducing animal testing, and promoting ethical, equitable data use worldwide.