Connected platforms eliminate manual entry and enable real-time insights from EHR to sponsor systems. Achieving scalable eSource: Single system for sites, simplified data integration for sponsors.
By Nick Frenzer, General Manager, Veeva Site Solutions, Veeva Systems
A common frustration in clinical research is the manual processes and dozens of technology systems required for execution. On average, clinical research sites use six or more systems per study, and more than 17 for complex trials. Considering that sites manage numerous studies at any given time, the strain on site staff to learn, access, and use different technology applications takes a toll on efficiency and productivity. Research sites are on the frontlines helping patients and are often subject to the “swivel chair” effect of bouncing between different screens to manually enter or verify data in disconnected systems.
A site-centric electronic source (eSource) that provides a central point of access for sites to capture and transmit data to sponsors can simplify the day-to-day work for investigators. When eSource is seamlessly connected with the sponsor’s electronic data capture (EDC) and upstream electronic health record (EHR) systems, data can flow from the point of intake straight to the sponsor.
The idea of connecting systems with eSource is not new in life sciences. Yet, most projects are still one-off integrations for a single study or to a specific technology system because scaling beyond a handful of trials has been costly and unattainable.
New eSource solutions deliver on true connectivity for end-to-end data flow across the clinical ecosystem. These applications can also eliminate quality assurance activities, like sponsor source data verification (SDV). The improvements in speed to insights and staff efficiency can accelerate execution and deliver end-to-end data flow from site to sponsor. To realize this potential, it is critical to understand what scaling eSource means for both research sites and sponsors and its long-term implications.
Site efficiency is often limited by sponsor-assigned technology applications, typically on a study-by-study basis. This means that research site staff must use the technologies given to them, even if they are not integrated with each other or with site-owned systems.
As sites take on more studies or work with more sponsors, they accumulate an increasingly complicated and siloed technology landscape. Nearly 60% of clinical research associates (CRAs) say that reconciling a research site’s manual trackers and workarounds from this disconnected tech ecosystem is their most inefficient task. These current processes are a major inhibitor to scaling eSource across studies, as data reconciliation lacks a digital framework for effectively sharing data.
Since eSource implementation has historically followed a sponsor-assigned pattern, sites accumulate study-by-study ways to capture data or transmit it to the sponsor’s EDC. The outcome is increased fragmentation and complexity, slowing down processes.
Site capacity and efficiency
A site-owned eSource, designed to meet the specific needs of investigators and integrated to receive data from the EHR and transmit it to the sponsor EDC, can offer a single solution for sites to use across their studies. To share data with sponsor systems, the eSource should leverage Fast Healthcare Interoperability Resources (FHIR) that enable the standardized exchange of health data. Using FHIR allows for sharing patient-level data in a compliant and secure environment and enables repeatability as standard practice for the site instead of bespoke integrations.
A single eSource application that can scale across all studies and multiple sponsors is a new approach for the industry. Sites having one place to capture data will eliminate manual transcription and remove the double or triple documentation currently happening during trials. Scaling eSource effectively saves time for staff and enables greater site capacity in the long run. With more efficient and productive ways of working, investigators can execute faster, partner with more sponsors, and take on additional trials.
Efficiency with a unified eSource
An eSource that is unified with a site’s clinical trial management system (CTMS) and electronic investigator site file (eISF) can become an operating system. The connected environment delivers economies of scale, reducing the staff burden and streamlining site workflows. A complete operating system for investigators improves processes for each site role:
-Clinical research coordinator (CRC): Saves significant time across all ongoing studies as everything a CRC needs is in one place. CRCs also don’t need to implement new integrations for every new study, a mapping and validation process that can take valuable hours of work.
-Principal investigators (PIs) and sub-PIs: No longer must jump across systems to review different aspects of the study, freeing up more time for study participants and patient care.
-Administrators: Gain clarity with a complete audit trail across functions, with visibility into exactly where trial data originated. This also lays thegroundwork for more robust reporting capabilities in assessing trial activities and financial information end-to-end.
These improvements to specific roles, whether at a growing site or academic medical center, open opportunities for sites to expand their scope or support more studies.
Deploying a complete operating system owned and managed by sites also sets the foundation for applying artificial intelligence (AI) effectively, which will further improve how investigators work. For example, adding agentic labor models to pull data from EDC and build a case report form (CRF) within eSource, or to synchronize a sponsor-provided protocol into a CTMS schedule of events. An eSource that is unified with a site’s other critical systems and integrated into EHR and EDC is ready for applying agentic AI and automation because it is free from traditional fragmentation.
End-to-end data flow for sponsors
Scaling eSource for sponsors has historically involved a combination of custom integrations, databases in the cloud, and negotiations between sponsors and hospital IT. The approach presents a data governance bottleneck, as both sites and hospitals are concerned with the risk of handling data that originates outside of the clinical ecosystem, especially when relying on customizations.
By partnering with sites that can now own, manage, and operate eSource and additional systems like CTMS, sponsors no longer need to architect complex data integrations to scale eSource. Sites can enable this connectivity much more efficiently, and in the case of EHR to EDC, enable sponsors with near real-time data access and transparency. Without the integration across site, sponsor, and hospital systems, attempts at scaling eSource won’t be successful.
Sponsors who have clinical systems on the same platform enable end-to-end visibility into study progress. With connected applications, clinical teams can automate data classification, cleaning, and orchestration, and focus on curating and analyzing the critical data needed for an effective trial and successful regulatory submission. The outcome is better data for sponsors, clinical teams performing analysis on clean and usable data, and reduced compliance risk.
With a more connected clinical ecosystem, the role of clinical data managers, for example, is elevated to prioritize higher-value work instead of data checks or interpreting an interface to a data lake. On average, data managers spend 12 hours per week per study on data review, cleaning, and reconciliation. Not needing to review every data discrepancy saves valuable time, improves quality, and moves studies toward risk-based quality management.
Reach, improving usability, and driving standards
Scaling eSource starts with functional changes at the site and standardization for sponsors. Both stakeholders will need to adapt their approaches to operationalizing technology and data standards.
During a trial patient visit, sites will need to assess how staff can best execute real-time direct data capture and review and share it quickly with the sponsor’s EDC. Every site collects this data in some format today, whether via paper or another software tool, before entering it in one or multiple systems. Instead of recreating yet another point of data capture, the goal is to redesign the workflow to orient it to a singular point of capture and review. That requires addressing the physical layout of the site space, participant scheduling approaches, and availability of tools like laptops or tablets during key points in the study workflow. It also requires looking critically at site systems and streamlining wherever possible.
A repeatable, scalable API integration to eSource also prompts sponsors to assess protocol designs and the requirements for capturing data. For example, CRFs include key fields like ethnicity that are often captured in different formats for each study. If a sponsor is working frequently with the same site on different studies, this variety will add unnecessary data checks that a streamlined API can reduce. Aligning CRF design to widely accepted standards can improve the effectiveness and scalability of eSource.
If sponsors align on standards and sites leverage a complete operating system that offers eISF, CTMS, and connected eSource, the industry gains end-to-end data flow. A scalable eSource removes the transcription effort, risk of human error, and complex programmatic checks that are the direct result of technology gaps between clinical systems. With connected applications and standard processes, the future of clinical research will be faster and more streamlined for the benefit of patients.