Solutions
The right infrastructure for every stakeholder
Principia pairs an RWD-native platform that speaks FHIR, OMOP, and SDTM/CDASH fluently with deep domain expertise, serving organizations across the health science ecosystem, from disease associations orchestrating multi-site research to biotech companies building their first registry.
Disease Associations
Orchestrate research networks that sustain your mission
Academic Medical Centers
Outgrow spreadsheet-based tools without enterprise overhead
CGT & Rare Disease Sponsors
Purpose-built for small populations and complex translational data
Emerging Biotech
Enterprise compliance without enterprise cost
Large Pharma — Observational Teams
A specialist platform for your real-world data workloads
Providers & Health Systems
Participate in research without disrupting clinical workflows
Data Standards & Biometrics
One governed metadata repository behind every study
CROs
Run every sponsor engagement on one governed platform
Regulatory Affairs
From evidence to submission on the same governed record
Quality & Safety Leaders
Signals, safety cases, and CAPAs on one data thread
Why teams choose CuRE
The same five outcomes, whatever your starting point
Every organization below adopts CuRE for a different first use case — but the payoff lands in the same five places: lower cost, faster evidence, fewer steps, validation built in, and questions their old systems could not answer.
New questions
Ask what siloed systems cannot answer.
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
Map once. Stop re-keying everything.
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
Studies start on data that already exists.
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
No separate validation project.
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 platform instead of a vendor stack.
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.
Disease Associations
Orchestrate research networks that sustain your mission
Disease associations sit at the center of CuRE ecosystems. We help you build and operate multi-site research networks that capture data from member sites, integrate it into shared research assets, and deliver value back to participants — creating a sustainable exchange that drives adoption, data quality, and long-term network growth.
A platform purpose-built for multi-stakeholder research ecosystems — not a clinical trial tool repurposed for registries. Member sites contribute data and receive insights, analytics, and decision support tools that improve care quality.
What we deliver
- Registry design, build, and lifecycle management via Control
- Multi-site network orchestration with governed data sharing
- Integrated data from EMRs (Conduit), labs, genomics, and PROs Compass
- Stakeholder portals with benchmarking and analytics Calculate
- Clinical decision support for member providers Cue
- Patient engagement and disease support applications Compass
Academic Medical Centers
Outgrow spreadsheet-based tools without enterprise overhead
Academic research teams need modern infrastructure that scales beyond manual data collection — without the cost and complexity of enterprise clinical systems. Principia provides a research-grade platform at academic-friendly pricing, with OMOP-native architecture that integrates seamlessly with institutional data assets.
Modern research infrastructure that scales with your ambitions — without requiring a dedicated IT team or enterprise licensing. Built for academic workflows, priced for academic budgets.
What we deliver
- Automated EMR data extraction via Conduit — replacing manual chart abstraction
- OMOP-native data harmonization across departments and affiliates Conduct
- Self-serve research enclaves with privacy controls Calculate
- Methods library for reproducible, publishable analytics
- Multi-institutional data federation without moving data
- Standards-based interoperability (FHIR, OMOP, i2b2, SDTM/CDASH)
CGT & Rare Disease Sponsors
Purpose-built for small populations and complex translational data
Cell and gene therapy trials generate uniquely complex data — from apheresis and manufacturing through clinical outcomes and long-term follow-up. Principia's platform is optimized for the small-population, high-complexity reality of CGT and rare disease, linking manufacturing variables to clinical outcomes in ways general-purpose systems cannot.
A platform that understands the CGT data journey — from cell collection through manufacturing to patient outcomes — not a traditional EDC with translational bolted on.
What we deliver
- Manufacturing-to-outcomes data linkage across the therapy lifecycle
- Translational data integration: apheresis, manufacturing, clinical, genomics
- Small-cohort analytics optimized for rare disease populations Calculate
- Randomization and trial supply management for small-population trials Cascade
- Long-term follow-up and safety surveillance Canary
- Registry lifecycle management for post-market commitments Control
- Patient-reported outcomes and eConsent for dispersed populations Compass
Emerging Biotech
Enterprise compliance without enterprise cost
Early-stage biotech companies need regulatory-grade infrastructure from day one, but can't absorb the cost and implementation timelines of legacy enterprise platforms. Principia delivers compliance-ready research infrastructure with rapid deployment — giving you the rigor investors and regulators expect at a fraction of the traditional price.
Get the data infrastructure of a top-20 pharma company — deployed fast, priced for your stage, and built to scale as your pipeline advances. No multi-year implementation. No per-seat surprises.
What we deliver
- Rapid deployment — production-ready in weeks, not months
- Regulatory-ready data capture and audit trails Capture
- OMOP-native data from the start — no costly migration later
- Scalable from single-site to multi-national as you grow
- Integrated safety monitoring and SAE workflows Canary
- Study lifecycle management without dedicated ops staff Control
Large Pharma — Observational Teams
A specialist platform for your real-world data workloads
Observational research and RWE teams inside large pharma often struggle with general-purpose clinical systems that weren't designed for real-world data. Principia provides a purpose-built RWD platform with OMOP-native architecture — designed from the ground up for the multi-source, longitudinal, and often messy reality of real-world evidence.
A specialist RWD platform that complements your existing clinical infrastructure — purpose-built for the observational workloads that general-purpose trial systems handle poorly.
What we deliver
- OMOP-native architecture designed for RWD from day one Conduct
- Multi-source data integration: EHR, claims, genomics, PROs, manufacturing
- Real-world evidence generation and submission-grade analytics — SDTM/CDASH outputs Calculate
- Risk-based quality management — centralized statistical monitoring and KRIs Caliber
- Network-scale data access through established research ecosystems
- Pharmacovigilance and post-market safety surveillance Canary
- Site and patient network access for pragmatic trials
Providers & Health Systems
Participate in research without disrupting clinical workflows
Principia's technology automates research data capture directly from your EHR, eliminating manual abstraction burden while giving your clinicians access to evidence-based decision support and outcomes benchmarking — a clear value exchange for participating in research networks.
Research participation that gives back: contribute clinical data and receive decision support, outcomes benchmarking, and quality tools that directly improve care at your site.
What we deliver
- Automated EHR data extraction via Conduit (SMART on FHIR)
- Near-zero manual chart abstraction with AI-driven validation Capture
- Clinical decision support at the point of care Cue
- Quality metrics and outcomes benchmarking Calculate
- Patient engagement and ePRO collection Compass
- Standards-based integration that works with your existing systems
Data Standards & Biometrics
One governed metadata repository behind every study
Standards, biometrics, and data-management leads carry the cost when CRFs, SDTM mappings, define.xml, and edit-checks are built — and reconciled — in parallel across disconnected tools. CuRE carries one governed study-design metadata record, a built-in Metadata Repository (MDR), so downstream artifacts are generated from the design rather than hand-rebuilt and reconciled by spreadsheet.
A metadata repository built into the platform — not a standalone standards tool reconciled against your EDC and submission datasets by hand. Your standards library and your study build are the same governed object, so a design change propagates instead of being re-keyed.
What we deliver
- Governed CDISC Controlled Terminology register — versioned, hash-anchored, platform-admin governed Conduct
- Concept / vocabulary service — search, hierarchy, semantic search, multilingual synonyms Conduct
- Canonical, USDM-shaped study-design model every app builds from Control
- End-to-end CDASH → SDTM → ADaM → define.xml traceability, generated from the design Conduct
- Reusable cross-study CRF / form library on the shared form engine Capture
- Design once, generate everywhere — CRFs, SDTM mapping, define.xml, and edit-checks emit from one source
CROs
Run every sponsor engagement on one governed platform
Contract research organizations typically inherit a different tool stack with every sponsor engagement. CuRE treats the CRO as a first-class organization in its own right — not a borrowed sponsor login — so your teams run study operations, data management, monitoring, and safety the same way across engagements, with each sponsor's data cleanly isolated.
One platform across your whole book of business: stand up a new sponsor engagement fast, deliver RBQM and inspection-readiness as differentiated services, and hand back clean, standards-native data at close-out.
What we deliver
- First-class CRO tenancy — CRO and sponsor organizations are distinct org types Control
- Study operations, milestones, and enrollment tracking across engagements Control
- EDC with AI-driven validation and query management Capture
- Randomization and trial supply orchestration Cascade
- Centralized statistical monitoring and KRIs for RBQM delivery Caliber
- TMF custody and continuous inspection-readiness Compend
Regulatory Affairs
From evidence to submission on the same governed record
Regulatory teams inherit evidence generated everywhere else — then reassemble it by hand for every submission, registration, and label. Because CuRE generates evidence and regulatory artifacts on one governed record, registrations, eCTD sequences, and label versions stay linked to the studies and analyses behind them.
A regulatory wing that sits on the same platform as the evidence itself — so what you submit is traceable to how it was produced, without the export-reformat-reconcile loop between clinical and regulatory systems.
What we deliver
- Registration lifecycle and health-authority interaction tracking Consulate
- Clinical-trial disclosure and transparency workflows — CT.gov and EU CTIS Consulate
- eCTD sequence assembly, validation, and lifecycle management Consign
- Label content and version management with structured SPL diffing Cachet
- TMF-grounded authoring scaffolding — CSR, SDRG/ADRG, Module 1 Compend
- Submission-grade analytics outputs traceable to the study design Calculate
Quality & Safety Leaders
Signals, safety cases, and CAPAs on one data thread
Quality and safety organizations usually run on systems that never talk: risk-based quality management in one tool, safety case processing in another, deviations and CAPAs in a third. CuRE runs them on one substrate, so a statistical signal, the safety case it becomes, and the quality action it triggers stay linked end-to-end.
One accountable picture for quality and safety leadership: monitoring signals, safety cases, and CAPAs carry shared lineage — so "how did you respond?" has one answer instead of three exports.
What we deliver
- Centralized statistical monitoring and key risk indicators Caliber
- Safety case management, MedDRA coding, and E2B(R3) export Canary
- OMOP-native signal detection — PRR, ROR, EB05 Canary
- Deviations, CAPA, training matrix, and internal audit Credo
- De-identification review and release gating for data sharing Curtain
- Cross-app lineage from monitoring signal to quality action
Cell & Gene Therapy
From cell collection to patient outcomes — one data thread
CGT and rare disease programs generate uniquely complex, multi-modal data across the therapy lifecycle. CuRE is designed to capture, link, and analyze this data end-to-end — enabling insights that siloed systems simply cannot produce.
01
Cell collection
Apheresis and cell-source records enter the governed record at the start — provenance begins at collection, not at the eCRF.
02
Manufacturing
Processing parameters, release criteria, and lot genealogy stay linked to the patient journey rather than trapped in CDMO systems.
03
Treatment
Randomization, supply, and administration are captured with a full audit trail on the same data thread.
04
Outcomes
Clinical outcomes, biomarkers, and translational data analyzed against manufacturing variables — in cohorts measured in dozens, not thousands.
05
Long-term follow-up
ePRO and safety surveillance built for the 5-, 10-, and 15-year commitments CGT regulators require.
Advisory & Consulting
Strategic services that complement our technology
Beyond our platform, Principia provides consulting and advisory services rooted in decades of experience building health science data systems and research networks.
Registry & Research Network Design
Design multi-stakeholder registry ecosystems — governance, data flows, sustainability models, and the value exchange that keeps member sites contributing.
OMOP & Standards Strategy
Plan OMOP-native migrations and CDISC adoption: vocabulary governance, CDASH-to-SDTM traceability, and submission-readiness designed in from the data model up.
System Architecture & Modernization
Architect scalable, standards-based research infrastructure — and chart the migration off the legacy systems that can't get you there.
Study & RWD Strategy
Design studies that exploit integrated real-world data assets — feasibility, protocol design, and evidence planning grounded in the data you already hold.
Let's discuss your needs
Every organization has unique challenges. We'll help you identify the right combination of technology and expertise.