eSource Implementation Consortium

Be Part of the Clinical Data Revolution

Join the eSource Implementation Consortium

Electronic source (eSource) clinical trials hold the potential to speed up the drug development pathway while driving down costs – but, to date, adoption has been slow and fragmented.

The eSource Implementation Consortium aims to change all that. The group, established under the auspices of the SCDM in 2017, brings science, industry, technology, and regulators together to work on the roll out of eSource applications that leverage  electronic health records (EHR), electronic data capture (EDC), and clinical data management systems (CDMS).

Members have a seat at the table of discussions and decisions surrounding the clinical trial sector’s biggest ever transformation.

Made up of science and technology providers and standards organizations as well as EHR and EDC vendors and technology providers, the Consortium works to:

  • Streamline existing data transfer processes to free up site staff to focus on patient touchpoints
  • Establish agreed-upon methods of clinical trial data transfer
  • Define best practice models to be scaled up across the clinical research enterprise
  • Share progress with the FDA Center for Drug Evaluation and Research Health Information Technology Board, and other regulatory authorities
  • Leverage existing clinical research HL7 Fast Healthcare Interoperability Resources standards where available

Current steering committee members include:

  • Memorial Sloan Kettering Cancer Center
  • Yale School of Medicine
  • Duke University School of Medicine
  • Washington University-St. Louis, School of Medicine
  • Novartis
  • Eli Lilly and Company
  • Bristol-Myers Squibb
  • Pfizer
  • Merck
  • Forte Research Systems
  • Health Level Seven International (HL7)
  • FDA  (pending)

The consortium aspires to develop data exchange specifications for core safety and various therapeutic area efficacy domains.

So far, we have defined a common core dataset using Logical Observation Identifiers Names and Codes (LOINC) standards and will operationalize data transfer from local labs using FHIR APIs and JavaScript Object Notation (JSON).

But there is much more to do. Together, we can shape the future of robust, effective, data-driven eSource clinical trials. Be part of the change you want to see. Join the eSource Implementation Consortium.

MEMBERS

MEETINGS

The Consortium is now open to all sites, biopharmaceutical companies, technology vendors, regulatory agencies, and those who are interested in learning more about faster clinical research data exchange.

To join please email our PM Mehdi Stambouli at [email protected] expressing your interest.

Contact Us