eSource

Rationale

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.

Benefits

Available Solutions