At IgniteData, we’re not just solving for data. We’re solving for speed, safety, and scientific clarity. IgniteData’s Archer platform automates the transfer of clinical trial data from hospital EHR systems to sponsor EDC systems, eliminating manual entry and accelerating timelines with unmatched accuracy.
In a recent conversation between Julie McCann, Head of Sales, and Dr. Jose Galvez, Chief Medical Officer and former FDA executive, we explored how the clinical research landscape is evolving, and how digital innovation like IgniteData’s Archer platform is driving that change.
From the FDA to IgniteData: A Mission-Focused Move
Before joining IgniteData, Dr. Galvez spent years at the NIH and FDA, where he worked to ensure the safety and efficacy of medical products.
“At the FDA, our role was to validate what the industry was doing and ensure what goes to market is safe and effective.”
That experience gave him a front-row seat to the challenges of clinical research—and the gaps slowing it down. What drew him to IgniteData was a chance to help fix one of the most foundational issues: manual data transfer.
“We do EHR to EDC. That means moving high-fidelity source data from the patient bedside straight into clinical data systems—without error-prone transcription.”
With Archer, IgniteData automates data transfer from Electronic Health Records (EHR) to Electronic Data Capture (EDC) platforms. The result? Clean, accurate data—delivered in near real time. That’s good for sponsors, great for sites, and ultimately life-changing for patients.
The Future Is Digital and Machine-Readable
But speed alone isn’t enough. Dr. Galvez sees digital protocols as the key to unlocking a new era of fully connected, scalable clinical trials.
Today, most trial protocols are written like academic papers. Someone still has to read, interpret, and translate them into electronic systems, a process that introduces delays and human error.
“We need digital protocols that are machine-readable and tagged with the right metadata. That way, clinical decision support tools can surface trials to physicians at the point of care—and even auto-generate CRFs.”
By advocating for structured, standardized trial design, IgniteData is helping lay the groundwork for automation, not just in data capture, but in trial discovery, enrollment, and operations. While broader adoption may be a couple of years away, momentum is growing, and Archer is already designed to integrate with emerging digital infrastructure.
Real-Time Data, Real-Time Decisions
So what does this look like in action?
Archer gives sponsors faster visibility into patient safety and drug performance by transmitting trial-critical data—labs, vitals, medications, adverse events—directly from the source.
“We’re talking about cardiac enzymes, liver function, toxicity indicators… Archer makes that data available quickly so decisions can be made sooner.”
That speed matters. Faster data means:
- Earlier detection of safety signals
- Quicker go/no-go decisions in early-phase studies
- More efficient allocation of research dollars
It’s not just operational efficiency, it’s smarter science, and it protects both patients and budgets.
Change Takes Trust: Why Sponsors Hesitate
If the value is so clear, why hasn’t every sponsor adopted this model?
“Medicine is still very much a paper-based practice,” says Galvez. “Even with EMRs, we’ve just taken paper workflows and digitized them—but we haven’t reimagined them.”
That legacy mindset makes change feel risky. But IgniteData understands that trust must be earned—and that’s where Archer shines.
The platform integrates directly into sponsor and site systems, aligning CRFs to source data using standardized ontologies like LOINC and SNOMED. This eliminates ambiguity and ensures that what flows into the EDC is exactly what researchers expect.
“An ontology is like a dictionary. It reduces ambiguity. When mappings are done right, there are no assumptions—just accurate, regulatory-grade data.”
And because Archer is built around SMART on FHIR protocols, data access is tightly controlled, fully auditable, and compliant with global privacy and consent standards.
Becoming a Sponsor of Choice
Archer doesn’t just help sponsors move faster, it helps them build stronger relationships with sites. By automating source data collection, Archer reduces the documentation burden on clinical research coordinators. That translates to:
- Fewer manual queries
- Smoother workflows
- Higher site satisfaction
In a landscape where trial sites are overburdened and under-resourced, sponsors who invest in site-friendly tech become easier to work with—and more likely to be invited back. That’s what it means to become a Sponsor of Choice.
The Takeaway
The next era of clinical trials isn’t speculative—it’s already here. With IgniteData’s Archer platform, sponsors are:
- Saving 20%+ per study
- Accelerating time-to-market by 10+ days
- Gaining 17+ days faster visibility into patient safety signals
- Becoming partners of choice for top-performing research sites
“IgniteData reduces clinical trial costs, timelines, and site friction—through automated data transfer, earlier signal detection, and seamless EHR integration.”
The future of research is real-time. Let’s build it together.
Book a 15-minute ROI session and see what’s possible.
