By Nick Frenzer, General Manager, Site Solutions, Veeva
LinkedIn: Nick Frenzer
LinkedIn: Veeva Systems
Developing new drugs and therapies is a contact sport for research sites. Investigators are on the frontlines, meeting and treating patients to help them live healthier lives. At the same time, sites are working through complex protocols, numerous disconnected systems, and manual processes that are costly in time and resources. This compounds for sites working with multiple sponsors as a recent research report found that 71% of sites say their top challenge is managing the number of sponsor selected vendor systems.
Sites bear the burden of disparate technology and over complicated workflows. As the number of data sources used in clinical trials increases and complexity grows, sites need modern tools to complete their mission-critical work. Many still rely on paper and manual data transcription to get things done, in 2026!
After meeting with experts from sites and sponsors to discuss opportunities that can have the greatest impact in advancing trial operations, one area kept coming up: eSource. Capturing data digitally at the source can significantly reduce the workflow for sites yet implementing it across studies has been seemingly unattainable.
Moving beyond one-off EHR to EDC connections
The promise of eSource has been around for years. By conducting direct data capture at the site and delivering it electronically to sponsors, the industry can eliminate errors, significantly lower source data verification (SDV), and save time and effort for sites and sponsors alike. The improvements can have a significant impact on a sites day-to-day.
The persistent issue with eSource is ensuring that the source data captured is the same as what is in the electronic health record (EHR), which sites typically re-enter manually. To more easily share source data, many sponsors have opted to build a stand-alone EHR-to-EDC (electronic data capture system) integration for a single use case. The integration is costly, and often, not scalable.
Fast healthcare interoperability resources (FHIR) is a technical standard by HL7 International that offers an alternative option by enabling the secure exchange of health data. FHIR is now largely seen as the industry standard. Before FHIR, data integrations were often complex, custom built, and a security risk. By using FHIR and applying it to clinical research integrations, organizations gain the ability to share patient-level data queries in a secure, regulated environment.
Clinical researchers will no longer need to query an EHR database, remap data tables, and translate the information into new data elements. FHIR advances the approach to data exchange, and it’s a good thing for healthcare and patients. Establishing FHIR-based data sharing enables the precise, automated transfer of audit-ready data elements, and provides the foundation for eSource to be scalable industrywide. In practice, a FHIR integration that connects EHR to EDC through eSource can deliver more accurate data to sponsors faster and securely.
To make progress scaling eSource, we know not to use legacy approaches which can’t be used broadly because they rely on bespoke, expensive integrations. Defining new roles for sites, sponsors, and hospital IT staff in clinical research and how each works together can provide an advanced strategy for digital data capture at the source.
Site-focused eSource
An eSource application that is owned, implemented, and managed by a research site can have an outsized impact on clinical trials. Managing the application enables sites to capture data with much less effort and execute more efficiently. eSource can eliminate the need for paper or duplicate data entry from an EHR, deliver higher quality data, and provide a better experience for all stakeholders involved.
Sponsors usually decide which eSource sites will need to adopt and use in a trial. With a site-owned eSource developed and designed for the needs of investigators, sponsors benefit from site efficiency and gain speed and cost savings. For example, sponsors will no longer need to work with hospital IT staff to validate whether a new eSource application can be used in a study.
A site-first approach to eSource is a novel idea in life sciences requiring new criteria for eSource providers, including:
Built for every research site: an application designed for all site types, that seamlessly connects to a research site’s other systems, including eISF, CTMS, and eConsent.
FHIR-based API standards: allows for the precise, automated transfer of audit-ready data elements. This is the foundation to integrate with EHR systems and realize data flow from EHR to EDC.
Deep industry expertise: deeply understand life sciences processes and aligned with the interest of sites, sponsors, and patients. Identify a strategic partner invested in your eSource success offering innovative new solutions for how data is captured in clinical trials.
With a site-focused eSource, the industry will have the foundation and infrastructure for seamless data flow from site to sponsor to hospitals. FHIR makes this a reality, enabling safe and secure data sharing, and the interoperability to scale beyond a single study.
If sites standardize how data is captured across their trials with a site-owned eSource, sponsors gain a complete picture into clinical development. The improvements can shave significant time in delivering much needed medicines to the patients that need them.
Realizing integrated data transparency across site and sponsor
Making an eSource that is owned and operated by a research site successful will require industry buy-in and alignment on the strategy. Adopting a new approach to trial data capture is a collaborative effort, and will call for close partnerships across sites, sponsors, hospitals, regulators, and technology providers.
Rethinking what eSource is, its role in clinical trials, and how it can be scaled across studies is an important first step. Together, sites and sponsors can continue to work towards clinical trials that are standardized, simpler, and more connected to help improve patient health.