Principia Health Sciences / est. 2020 / Cary, NC
From real-world data to submission-grade evidence.
Principia builds CuRE — Collaborative Research Ecosystems — so disease associations, clinics, patients, CROs, and sponsors can use one governed record across the entire research pipeline. EHR, registry, lab, patient-reported, manufacturing, shipping, biomarker, and cytogenetic data resolve to OMOP, then flow into analytics, quality, safety, TMF, and regulatory outputs without rebuilding the dataset for every question.
01 / Platform overview
One platform. Every product.
One governed record.
At the heart of CuRE is one governed OMOP record. Rather than a long catalog, the suite is grouped the way you buy it — into bundles owned by the team that runs them, all sitting on the shared record the Core builds and governs.
02 / Why CuRE is different
Five reasons CuRE is different.
Not another EDC with a data lake bolted on. CuRE is an end-to-end research pipeline: one governed record, cross-modal evidence, regulated outputs, and validation evidence carried through every product.
One governed record across the work.
Clinical, registry, patient-reported, safety, TMF, regulatory, and AI-assisted work all resolve to the same governed OMOP substrate instead of reconciling flat-file islands.
RWD-to-submission evidence pipeline.
FHIR, CRO files, registries, labs, claims, and patient inputs map once to OMOP; downstream products carry that evidence toward SDTM/CDASH, TMF packages, eCTD sequences, registrations, and labels.
Cross-modal answers incumbents cannot reach.
Ask whether cryopreservation approach, manufacturing variance, shipping time, biomarkers, ePRO adherence, and EHR history affect CAR-T outcomes without building a one-off dataset.
Compliance and validation by construction.
21 CFR Part 11, EMA Annex 11, HIPAA, validation evidence, audit trails, source lineage, AI logs, and regulatory acknowledgements are product substrate, not a late validation project.
Time to value: fewer steps, fewer clicks.
CuRE removes research busywork: fewer duplicate entries, fewer reconciliation passes, fewer manual queries, less deck assembly, and less thinking required to move from question to evidence.
Streamline or eliminate research steps instead of automating the same old handoffs.
See how the platform fits togetherReal-world evidence happens in patient journeys.
Dense, not cramped.
Clinical research is information-rich. The interface earns space with alignment, tabular data, and hierarchy instead of padding everything into sameness.
Semantic color does real work.
Teal means automated, amber means attention, sky means information, and magenta marks AI-assisted work. Color carries state.
Context persists.
Study, site, patient, cohort, and time cursor should follow the user across surfaces, pages, and refreshes.
Provenance is visible.
Every important value should show whether it was entered, ingested, suggested, reviewed, locked, or overridden.
AI stays attributable.
AI features should expose confidence, source material, and correction paths instead of hiding authorship behind a magic button.
03 / The unified record
One patient record, stitched from every source.
EHRs, labs, registries, claims, patient apps, and cytogenetics map through open standards into one governed record — FHIR on the way in, OMOP as the analytical backbone, submission-grade SDTM/CDASH on the way out.
04 / Parsing at scale
Cytogenetics, parsed at scale.
CuRE Cyto turns free-text ISCN karyotypes into structured, analyzable records — automatically, as a step in your data pipeline rather than manual re-keying. Chromosome count, sex, abnormality type, breakpoints, and cell counts resolve into the governed OMOP record, ready for cohorts and analytics.
The same engine runs live in your browser — paste a karyotype or pick an example to watch it resolve on the page.
See the full cytogenetics workflowEnter an ISCN string above or click an example to see it parsed.
This is a lightweight demo — for full ISCN 2016/2020 parsing, visit cyto.principia.health
In practice / Cell therapy registry
Modernizing a registry without disrupting operations.
An international cell therapy registry maintains one of the world's most important transplant datasets. Our approach maps donor and outcomes data to OMOP in place and adds continuous quality scoring — designed so no operational system has to go offline, and the full OHDSI toolkit opens up on top.
Read the case study05 / From the team
Three pieces worth your time.
Why legacy EDC is holding back outcomes research.
Electronic data capture was built for trials, not for the longitudinal reality of outcomes research.
Read moreThe real-world evidence generation gap.
Everyone agrees RWE is the future. Almost nobody has the infrastructure to generate it systematically.
Read moreThe economics of real-world evidence.
The infrastructure-reuse multiplier is the only answer that scales when labor dominates RWE generation.
Read moreTalk to Principia
Let's talk about your most difficult clinical trial and RWE challenges.
We engage leading non-profits, health systems, and biopharma organizations on programs ranging from data integration and report automation to full CuRE network buildouts.
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