For clinical research teams, the promise of EHR eSource automation is exciting. But excitement is quickly followed by practical questions about integration, compliance, and site adoption. At Mahalo, we believe transparency is key.

Below, we answer the most common questions we hear from sponsors, CROs, and research sites so you can evaluate the real-world impact of EHR-to-EDC integration with confidence.

How difficult is it to integrate Mahalo with the technology we already use?

Our approach is built on configuration, not custom coding.

Mahalo adopts the modern SMART on FHIR standard to connect with EHRs through secure, standardized interfaces. This means no local software to install at sites and no need for lengthy custom development projects. Beyond the EHR, we provide a robust suite of REST APIs to connect with your CTMS, analytics platforms, or other key systems.

For organizations with a preferred EDC, our solution can be used for eSource, eConsent, or ePRO, syncing all data back to your existing database of record in near real-time.

What happens if the EHR is missing fields or data is updated later?

We treat data from the EHR as untouchable source data. If a field isn't present when data is pulled, our system doesn't guess or fill in the blanks—it preserves exactly what's in the patient's chart.

When the EHR is updated later (e.g., a new lab result is added), Mahalo’s system automatically detects the change the next time data is pulled. It adds or updates only what has changed, maintaining a complete and traceable audit trail of where and when every piece of data originated. If something isn't available in the EHR, coordinators can still add supplemental data manually in the CRF.

Our site staff is busy. How do you drive user adoption?

Technology is only effective if people use it. Our adoption strategy is built on simplicity and support:

• Simple UX: Users launch the tool from the patient chart with a single click. There are no extra logins to remember, and the interface is intuitive.
• Proven Playbook: We partner with you to identify an internal champion and follow a clear, tested rollout plan.
• Hands-On Support: Our team provides role-based training, sandbox environments for practice, and hands-on support through configuration, validation, and go-live.

Teams consistently report fewer clicks, less duplicate work, and higher confidence in their data.

Is there a full audit trail, and can we export it?

Yes, and yes. For every participant, Mahalo maintains a comprehensive, 21 CFR Part 11 compliant audit trail. It clearly distinguishes between data pulled directly from the EHR and data entered manually by a user.

The log captures who, what, and when for every change and includes resource identifiers that trace data back to its origin in the EHR. The entire audit trail is searchable and can be exported for monitoring, regulatory submissions, or sponsor review.

What is the real setup time, and what are the day-to-day savings?

While every site is different, a typical implementation takes 4 to 8 weeks of elapsed time. This includes site governance, change control, validation, and training. The hands-on effort required from site staff during this period is usually around 15-30 hours total.

Once live, the time savings are significant. Teams regularly see:

• A 50-70% reduction in data entry time.
• Drastically lower query rates due to fewer transcription errors.
• Faster eligibility screening and visit workflows.

The Future is Configurable and Compliant

Choosing an eSource solution is about more than just technology; it's about choosing a partner. At Mahalo, we deliver a platform that is secure, compliant, and designed for the reality of today's clinical research sites.

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