De-risk and fast-track your neurovascular trial imaging.
From first study imaging to clinical device approval. Eppdata is the Integrated Imaging Organization for neurovascular trials: reading expertise, proprietary imaging software, and regulatory-grade data packaging in one place, from first scan to approval across FDA and EMA. No handoffs, no surprises at submission.
8 of the top 10 neurovascular device companies trust Eppdata.*
* “Top 10” neurovascular device manufacturers per Research and Markets (2025).
Not a core lab. An Integrated Imaging Organization.
A traditional core lab reads images and hands you a report. But when a submission hits a regulatory question, that report is all you have. With regulators scrutinizing trial imaging more closely than ever, these moments are no longer the exception. An IIO owns the full pipeline on proprietary software: AI-powered QC, end-to-end documented reads, and regulatory packaging built in from day one. The output isn't a reading. It's a regulatory asset.
Traditional core lab
- Image reading only - scope ends at the report
- Third-party software introduces translation errors
- Regulatory consultant engaged late, after data is locked
- Manual QC - problems surface at submission
- Siloed vendor - you manage every handoff
IIO
- Full study lifecycle - design, reading, analytics, submission
- One proprietary software stack - technical depth from screening solution to final export
- Regulatory built in from day one - CLC writing to submission
- AI-augmented QC and advanced secondary analyses
- One team accountable end-to-end
Figures as of March 2026
Three advantages under one roof.
When reading, software, and regulatory expertise share the same house, structural advantages emerge that a stack of separate vendors can't reproduce.
Cleaner data
Domain-specific data managers apply AI-powered quality checks for every variable - within and across visits - before images ever reach a reader.
- Purpose-built QC logic, not generic checks
- Pattern recognition with AI re-training
- Reading–metadata bidirectional sync
- Higher image quality, more complete visits
Predictable delivery
Readers work directly inside our own software - no translation delays, no vendor waiting games, no rework loops between systems, so timelines hold.
- Direct issue handling, consensus on the fly
- 300+ reads per week capacity
- 30 contracted neuro readers, always available
- No rework loops between systems
Submission-ready results
Regulatory expertise is built in from study design - not bolted on at the end. CLC, audit trail, and submission packages live in the same workflow.
- CLC writing & endpoint operationalization
- Complete audit trail, hosting, archiving
- Submission packages for FDA, EMA & EU-MDR
- Built for audit readiness
One platform. A different answer for every stakeholder.
Three levels of value. Most partners stop at the first.
Execution stability is table stakes. Regulatory integrity is rare. Strategic data intelligence is ours alone.
Operational control
Study-specific PACS · reader blinding · ticketing & re-upload · global site network.
Regulatory integrity
CLC writing · endpoint design · study-sheet mapping · consensus strategy · submission packages · hosting.
Strategic data intelligence
Integrated 2 + 1 Consensus engine · Multidimensional QC · Secondary & meta-analyses · ML & synthetic control arms · Publication support · KOL-level neuro expertise.
Proven in pivotal trials that shaped the field.
Our work is part of the published neurovascular evidence base - named, peer-reviewed, and citable. That is the proof behind Level 3.
“Reading study images and understanding them are two different things. Imaging often defines the primary endpoint, but study software treats image analysis as an afterthought. So we built it ourselves - with image analysis at the core.”
Prof. Jens Fiehler, MD PhD · Co-Founder & Managing Director
Chairman, Diagnostic & Interventional Neuroradiology, UKE Hamburg · 900+ publications · h-index 76 · Past President ESMINT
Three device manufacturers. An IIO they trust.
Independent feedback from three different device manufacturers in the neurovascular space.
Having worked with numerous imaging core laboratories across global clinical programs, Eppdata consistently distinguishes itself through its scientific expertise, regulatory rigor, and operational excellence. Over six years and multiple neurovascular studies - now initiating our third together - they integrate seamlessly with sponsor processes while consistently delivering reliable, high-quality data.
Director, Clinical Science and Data Integrity.
one of the top-five device manufacturers
What truly differentiates Eppdata from other core labs is their deep scientific and clinical engagement throughout the study lifecycle. Beyond standard image reads, they actively contribute to advancing study methodologies and help define new standards in emerging areas.
Director, Global Clinical Research
one of the top-five device manufacturers
We used Eppdata on a number of small EU studies and didn't hesitate to make them our partner of choice for the IDE/PMA. Communication throughout the trial was excellent, they made it easy to review data as it came in, and their justification for scoring was thorough. Knowing they run a tight ship with audits makes me confident going into the next phase of the PMA process. I'd recommend them and use them again.
CEO of a neuro-endovascular device company,
recently acquired by one of the top-five device manufacturers
More than 30 in-house specialists - half medical, half tech.
Additionally supported by a large contracted network of 40+ interventional neuroradiologists - the depth behind every study.
Study Coordination
- Dedicated single point of contact (SPOC)
- Project management across the study lifecycle
- Reading- and study-quality control
- Study design & core-lab set-up
Image QC & Data Management
- Intake gating & completeness checks
- Visit, device & image verification
- Pseudonymization control
- Rating assignment
Regulatory & Compliance
- SOPs & standardized processes
- Certification & documentation
- Audit readiness (BIMO / US IDE)
- ISO 9001 quality management
Let's talk about your trial.
Whether you're designing a new trial or rescuing one with imaging QC problems, Eppdata is the partner built for exactly this.