Principia Health Sciences / est. 2020 / Cary, NC
Principia builds CuRE — Collaborative Research Ecosystems — so research organizations run the entire evidence pipeline on one governed record. Data maps to OMOP once, then flows into analytics, safety, quality, TMF, and regulatory outputs without rebuilding the dataset for every question.
Why CuRE is different
Not another EDC with a data lake bolted on. CuRE removes research handoffs instead of automating them — so the win shows up as questions you could not ask before, fewer steps, faster evidence, validation built in, and lower cost.
New questions
Cross-modal questions are native: link manufacturing, shipping, biomarkers, ePRO adherence, and EHR history to clinical outcomes without building a one-off dataset for each question.
Fewer steps
Data maps to OMOP a single time and every product reads from it — no re-entry between capture, analytics, TMF, and publishing, and far fewer queries, reconciliation passes, and decks assembled by hand.
Faster time to evidence
Because patient data flows continuously into one governed record, studies stand up in weeks and a new safety or quality signal becomes analysis the same day — not after a months-long data-engineering project.
Validation built in
21 CFR Part 11 / Annex 11 audit trails, source lineage, AI logs, and validation evidence are captured as the platform runs — so GxP readiness is a byproduct of the work, not a separately-budgeted project bolted on at the end.
Lower cost
One data model and one validation story replace per-vendor licenses, integration projects, and re-validation cycles — a fraction of the cost of assembling the same capabilities from point solutions.
01 / Who CuRE is for
Orchestrate research networks that sustain your mission
Outgrow spreadsheet-based tools without enterprise overhead
Purpose-built for small populations and complex translational data
Enterprise compliance without enterprise cost
A specialist platform for your real-world data workloads
Participate in research without disrupting clinical workflows
One governed metadata repository behind every study
See every solution →Advisory services, the CGT deep-dive, and full capability lists per audience.
02 / Platform overview
At the heart of CuRE is one governed OMOP record. The suite reads the way evidence flows: collected at sites and from patients, governed into one record, operated and monitored, analyzed, submitted, and carried into portfolio and market-access decisions. Every product appears once, in the stage where it does its work.
03 / Benefits of integration
Integration is not just a cleaner architecture diagram. It changes the questions a research organization can ask, because operational work, clinical evidence, safety, quality, and regulatory outputs all point back to the same governed record.
Read the whitepaperEDC, operations, safety, RBQM, EHR, and outcomes resolve to one governed record.
Site quality is measured by total evidence burden, not just enrollment speed.
Supply, chain-of-custody, clinical outcomes, and safety data stay linked.
Operational variance becomes clinical insight.
Protocol operations, EHR eligibility, site execution, and longitudinal outcomes can be queried together.
Design studies around patients who actually exist and sites that can execute.
EHR workflow, study operations, care-team activity, and patient outcomes share context.
Measure whether point-of-care engagement changes the study, not just clicks.
Site capability profiles come from governed evidence, not self-reported feasibility PDFs.
Feasibility from evidence, not surveys.
Regulatory lifecycle records remain connected to the evidence and analyses behind them.
Regulatory content stays connected to the evidence record.
Real-world evidence happens in patient journeys.
Clinical research is information-rich. The interface earns space with alignment, tabular data, and hierarchy instead of padding everything into sameness.
Teal means automated, amber means attention, sky means information, and magenta marks AI-assisted work. Color carries state.
Study, site, patient, cohort, and time cursor should follow the user across surfaces, pages, and refreshes.
Every important value should show whether it was entered, ingested, suggested, reviewed, locked, or overridden.
AI features should expose confidence, source material, and correction paths instead of hiding authorship behind a magic button.
04 / The unified record
EHRs, labs, registries, claims, patient apps, and translational data 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. One governed study-design metadata record — a built-in Metadata Repository — drives the CRFs, SDTM mapping, and define.xml, so submission artifacts are generated from the design rather than hand-rebuilt in parallel.
05 / See it, then try it
No sales call required. CuRE apps ship live, in-browser demos of their real engines — synthetic data, actual logic — on their product pages. Start with the screenshots, run a single engine, or follow one synthetic record through the whole pipeline.
Generate a real randomization schedule — block, stratified, biased-coin, or minimization — and watch arm balance hold.
Run the demo → CuRE ConductPaste a FHIR Condition resource and watch it map to an OMOP condition_occurrence row.
Run the demo → CuRE CanaryEnter drug–event counts and compute PRR / ROR / EB05 disproportionality signals.
Run the demo → CuRE CytoParse a free-text ISCN karyotype string into structured, queryable data in your browser.
Run the demo →06 / From the team
Electronic data capture was built for trials, not for the longitudinal reality of outcomes research.
Read moreEveryone agrees RWE is the future. Almost nobody has the infrastructure to generate it systematically.
Read moreA practical look at the cross-domain questions CuRE can answer when research operations, evidence, and regulated outputs share one data spine.
Read more07 / How you adopt CuRE
An integrated platform shouldn't mean an all-or-nothing purchase. Sign one enterprise agreement — priced to start at a single app — and grow into the suite on your timeline, with no integration work between CuRE products as you add them.
Priced as one app, with the whole suite entitled from day one — no re-procurement to grow.
One governed record, so your data surfaces in every app the moment it lands — explore before you activate.
Turn on regulated and advanced features per app, when you need them. Pay for what you actually run.
CuRE apps are natively connected; adapters for outside systems — EHRs, safety, eTMF — are already built.
Talk to Principia
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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