The eSource Initiative aimed to assist sponsors in overcoming challenges in moving towards more efficient data gathering practices to benefit patients, sites, and sponsors.  Multiple assets and thought leadership pieces are available on the TransCelerate eSource Solutions page. While the eSource Initiative is completed, TransCelerate continues to pursue these aims through engagement in the Vulcan HL7 FHIR® AcceleratorTM (


The eSource Initiative supported TransCelerate Member Companies and other stakeholders in accelerating the uptake of eSource for clinical trials. The application of the use of electronic sources of data for clinical trials has been slow to be adopted across the industry, particularly for registration trials, due in part to difficulties in operationalization. Research indicates there are numerous obstacles and challenges behind this delay—some real and some perceived.

As the source of protocol-defined data points has increasingly expanded to include data from patient records and other electronic sources such as devices and apps, electronic interoperability and consistent use of data standards become paramount.

The eSource Initiative sought to assist trial sponsors in overcoming these real and perceived challenges to influence more efficient data gathering practices to benefit patients, sites and sponsors.

TransCelerate has, and continues, to help the industry achieve eSource in these two ways:

  • Innovative solutions, tools and thought leadership
  • Vulcan engagement

Our work continues…

TransCelerate acknowledges EHR data interoperability as foundational to streamlining clinical trial data collection and reducing burden on patient and sites. That is why TransCelerate is a founding member of the Vulcan FHIR® Accelerator, an organization with the remit to accelerate interoperability of health data to integrate clinical research with clinical care.

Our work to drive value of eSource implementation continues through this collaborative engagement. Leveraging HL7’s Fast Healthcare Interoperability Resource (FHIR®) standard, we envision a future state where clinical care data is research-ready at the source and secondary use of EHR data for research is a matter of routine – reducing burden across the drug development lifecycle and ultimately improving patients’ lives.


  • Potential to eliminate duplicate data entry, reduce transcription errors
  • More informed vendors
  • More engaged patients
  • Greater efficiency for sites and monitors (potential for full RBM)
  • Potential for improved Health Authority review/approval process
  • Greater traceability for end-to-end data flow

Available Solutions

For more information and to explore our solutions, visit our Initiative Solutions page.

Related Initiatives

Quality Management System

Through partnerships with Health Authorities and other industry stakeholders, the Quality Management System (QMS) Initiative aims to explore ways to improve quality across the industry.

Risk Based Monitoring

The Risk Based Monitoring Initiative was established in 2012 as one of the five initial goals created by TransCelerate to drive efficient and effective solutions into the R&D industry. Clinical trial sites have varying levels of experience and quality, but monitoring approaches are not designed to manage potential differences.

Clinical Data Transparency

The Clinical Data Transparency Initiative was formed with a mission of developing a model approach for redacting privacy information found in clinical study reports and a model approach for the anonymization of patient-level data shared with the broader healthcare community.