EHR integration: Driving clinical trial efficiency

The traditional approach, which relies on manual data entry and siloed systems, has become a major roadblock to efficiency and scalability. One of the clearest opportunities to modernize trial operations is through the integration of Electronic Health Records (EHRs) into clinical trial workflows.

EHRs already contain much of the data needed for successful trials: comprehensive medical histories, current medications, lab results, and real-world treatment patterns. When this information is incorporated directly into trial workflows, it creates opportunities to enhance efficiency throughout the drug development lifecycle. A recent study showed that EHR-integrated trials can accelerate recruitment timelines up to 20 times by streamlining patient identification and screening to drive faster, more efficient research.

Bringing together EHR integration with other real-world and historical data sources can unlock real benefits for everyone involved. Today, many clinical trials are still slowed down by manual steps that stretch timelines by months. By supporting smarter study design, speeding up patient identification and recruitment, enabling real-time monitoring, and strengthening participant involvement, teams can cut trial durations and see meaningful improvements in both cost and efficiency.

This article explores how sponsors can take advantage of EHR integration to make clinical trials more efficient and scalable in today’s increasingly digital world.

Transforming clinical trial operations with EHR integration

EHR integration represents a practical and powerful way to modernize how clinical trials run. Enabling real-time data flow between healthcare providers and research platforms helps to streamline operations, reduces administrative burden, and drives better outcomes. When done well, EHR integration can drive real, measurable improvements across the trial lifecycle.

Inform protocol development

One of the toughest challenges of trial management is experiencing well-designed protocols fall apart when faced with real-world patient populations. Studies often see delays by months because initial designs overlook real patient data and treatment histories are not fully considered. The result is that protocols that may look good on paper, don’t align with actual clinical practice, leading to costly amendments. Access to richer patient data provides sponsors with essential insights like demographics, comorbidities, and prior treatments that reflect clinical realities from day one. A recent analysis found that using EHR data to inform protocol development helps teams to understand patient populations and care pathways before a trial begins, reducing the likelihood of amendments and leading to more streamlined and cost-efficient studies.

Enhance recruitment and screening

Recruiting eligible patients remains one of the most time-consuming and resource-intensive steps in running a trial. Traditional approaches often rely on manual chart reviews or referrals from physicians –methods that are slow and likely to overlook potential participants and hinder efforts to recruit diverse populations. EHR integration solves this problem by automating the process of patient identification, continuously scanning patient records in real-time to flag individuals who match a trial’s inclusion and exclusion criteria. Instead of relying on manual efforts, advanced query tools can translate protocol requirements into structured searches that evaluate multiple data points simultaneously – from demographics and diagnoses to lab results and medication histories. This not only accelerates recruitment, it also broadens the pool of potential participants. Trials can more easily identify candidates who might not otherwise be referred or considered, leading to more diverse and representative enrollment. Sponsors that leverage EHR-based screening have seen recruitment timelines shrink significantly, enabling faster trial starts and more efficient resource use.

Capture in-flight data

One of the tougher aspects of running a trial is keeping track of what’s happening with participants in real-time. Critical data is often managed by manual processes or is stuck siloed in EHRs which can lead to delays, missed updates, and risks crucial details being overlooked by clinical trial teams or investigators. EHR integration transforms this paradigm by creating automated data flows between clinical care and research documentation. Instead of waiting for scheduled study visits to discover important changes in a participant's status, alerts of significant events are triggered real-time. Study teams can then intervene promptly rather than discovering issues weeks later during source data verification. This can fundamentally reshape how trials are managed. Getting near real-time insights through adaptive trial designs means sponsors can make adjustments sooner, whether that’s tightening criteria, flagging a safety issue, or even sunsetting a treatment that isn’t working. Less lag, fewer delays tied to safety reviews, and quicker resolution of issues can save weeks which could keep a trial on track that would otherwise fall behind.

Engage study participants

Getting people to join a clinical trial is hard enough but keeping them engaged through the end is even harder. A common reason participants drop out is due to poor communication. They don’t receive updates about study progress, are uncertain about activities happening behind the scenes, and are unclear if their participation really matters. EHR-connected patient portals, like the ones many already use for routine care, can give participants trial updates, appointment reminders, and even access to their own data. When people feel informed and valued as partners in research rather than test subjects, they are more likely to stay involved. Better engagement means reduced dropout rates and when every data point matters, improved retention can make a difference.

Building an EHR integration strategy

To fully capture the benefits of EHR integration, sponsors need to move beyond pilot efforts and toward a comprehensive strategy. That starts with interoperability and standards like HL7 FHIR that are key for making sure data can move securely and efficiently across providers, systems, and platforms. Leveraging established standards rather than custom-built interfaces enables companies to scale the real-time data exchange that is necessary for responsive trial management. But it’s not just about connectivity, security and privacy must be in focus from the outset. Whether it’s HIPAA, GDPR, or FDA guidance, organizations need to meet compliance expectations while building trust with both patients and partners to share data confidently.

Engaging with healthcare providers is essential since they’re the ones collecting much of the data in real time. By aligning trial requirements with clinical workflows, data capture becomes a natural extension of patient care rather than an unnecessary burden. When EHR data flows into advanced analytics platforms, it creates opportunities to spot trends, refine trial designs, and make faster, better decisions.

For sponsors responsible for clinical trial strategy and operations, EHR integration is becoming a strategic imperative rather than just an operational improvement. Organizations that establish these capabilities are positioning themselves for advantages in trial speed, cost, and quality outcomes.

We’re helping clients make the shift toward trials that are more connected, more efficient, and more patient centered.

This article was first published in Clinical Leader.