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OrenHealth · Research & Life Sciences

Study-grade AI infrastructure for research firms that refuse to rent their research intelligence.

Clinical research runs on data integrity, regulatory traceability, and operational coordination across investigators, coordinators, sponsors, and IRBs. OrenHealth builds workflow infrastructure aligned to that operating reality — HIPAA-aligned, 21 CFR Part 11-aware in architecture, and scoped to support research operations without crossing into territory that requires a CRO, GxP validation house, or FDA-regulated software clearance.

Open a Research Briefing Download Capability Statement
HIPAA Architecture
BAA Ready
21 CFR Part 11 Aware
IRB-Aligned Workflow
The Research Operations Mandate

Built for how clinical research and life-sciences operations actually function.

Investigator sites, sponsor research operations, and academic medical center research divisions all share the same daily reality: protocol-driven workflow, audit-traceable data handling, and coordination across people who don't share a single system. OrenHealth ships infrastructure aligned to that reality — and stays honestly inside the boundaries of what is appropriate for non-validated, non-GxP software.

HIPAA-Aligned Architecture

PHI handling, encryption-at-rest and in-transit, audit logging, role-based access controls, and breach notification posture engineered for research environments handling participant-identifiable data.

21 CFR Part 11 Aware

Architectural design reflects electronic record and electronic signature principles — audit trails, access controls, time-stamped records. Full Part 11 validation for regulated systems is sponsor- and study-specific; we coordinate with your validation partner, not replace them.

IRB & Sponsor Coordination Aware

Protocol-driven workflows, consent process integration, and sponsor communication patterns built around how investigator sites and research operations actually coordinate with their IRB of record and study sponsor.

PI & Coordinator Engagement

Direct counterpart access to the founder and senior engineering for principal investigators, research coordinators, and research operations directors. No SDR funnel — operational counterpart conversation from the first briefing.

Research Platform Awareness

We integrate around the systems clinical research already runs on.

OrenHealth does not replace your EDC, eTMF, CTMS, or eConsent system. We orchestrate workflow around those platforms — participant communication, recruitment funnels, operational dashboards, sponsor-side coordination — against vendor-published APIs and standard research interoperability protocols.

REDCap
OpenClinica
Castor EDC
Veeva Vault
Medidata Rave
IQVIA Technologies

Platform names referenced for integration context only. OrenGen Worldwide LLC is not affiliated with, endorsed by, or a reseller of these vendors. All trademarks are property of their respective owners.

Capability Stack

Six pillars engineered for clinical research and life-sciences operations.

Each pillar is deployable as a standalone engagement or composed into a research operations modernization program. Scope, BAA terms, and integration boundaries confirmed during the research briefing.

01 / Infrastructure

HIPAA-Aligned Research Infrastructure

Dedicated server tenancy with participant-data segregation, encryption at rest and in transit, access logging, and audit trail preservation. Architecture reflects 21 CFR Part 11 electronic records principles for non-validated operational tooling.

Audit Trail BAA Ready Part 11 Aware
02 / Coordination

Study Coordination & Participant Workflow

Operational workflow for study coordinators — participant tracking, visit scheduling, protocol adherence checkpoints, sponsor communication queues, IRB submission status tracking. Operational coordination, not regulated clinical data capture.

Visit Scheduling Protocol Tracking Sponsor Comms
03 / Operations

Research Operations Intelligence

Dashboards against operational research metrics — recruitment funnel performance, screen-fail rates, retention by site, enrollment-to-target progress, query response cycle times. Operational analytics, not clinical data analysis or biostatistics.

Recruitment Funnel Retention Analytics Enrollment Tracking
04 / Integration

EDC / CTMS / eTMF Integration Layer

Integration layer between your existing research platforms and the operational tooling your team uses — recruitment platforms, participant communication, scheduling, IRB tracking. Vendor APIs, standard research interoperability protocols where available, scoped per engagement.

EDC API CTMS Sync Workflow Glue
05 / Communication

Participant Communication Infrastructure

HIPAA-compliant participant messaging — visit reminders, follow-up sequences, retention outreach, screen-fail communication, study-completion handoff. Scoped to operational and administrative communication; does not include clinical advice, adverse event triage, or unblinded study communication.

Visit Reminders Retention Outreach Secure Messaging
06 / Advisory

Research Operations Strategic Advisory

Fractional CTO and research operations strategy for principal investigators, research directors, academic medical center research offices, and sponsor-side operations teams. AI roadmap, technology stack rationalization, vendor consolidation, operational governance.

Fractional CTO Ops Roadmap Vendor Rationalization
Engagement Scenarios

How research firms actually contract with OrenHealth.

Concrete patterns we ship into the clinical research and life-sciences market. Every engagement starts with a 30-minute research briefing to confirm scope, BAA terms, integration boundaries, and what is explicitly out of scope.

Scenario 01

Investigator-Initiated Study Operations Support

Principal investigators running investigator-initiated studies at academic medical centers and independent sites engage OrenHealth for operational workflow — recruitment outreach, participant communication, visit scheduling, IRB submission tracking. Operational support layer around your existing REDCap or institutional EDC instance.

Scenario 02

Multi-Site Research Network Coordination

For research networks, consortia, and multi-site investigator-initiated studies coordinating across 5–50 sites. Workflow orchestration for site activation status, central recruitment coordination, cross-site enrollment dashboards, and standardized participant communication. Does not replace sponsor-mandated CTMS.

Scenario 03

EDC / Research Platform Integration Wrapper

For research operations already invested in a primary EDC, CTMS, or eTMF platform but missing connective tissue. We build the integration layer between your research platforms and the operational tooling your team uses day-to-day — recruitment systems, participant SMS, scheduling, IRB tracking, sponsor reporting.

Scenario 04

Sponsor & CRO-Side Operations Advisory

For sponsor research operations groups and CRO operational leadership evaluating where AI and workflow automation fit inside an already-regulated stack. Fractional CTO engagement covering AI governance posture, vendor evaluation framework, and operational-versus-validated-system boundary mapping. Strategic, not implementation.

PI & Research Director FAQ

The questions a principal investigator or research director should actually ask.

Honest answers on regulatory posture, what we do and don't do inside a clinical research environment, and where we hand off to specialized validation, CRO, or FDA-regulated software partners.

Are you 21 CFR Part 11 validated, and what does "Part 11 aware" actually mean here? +
We are not a Part 11-validated system, and we do not market ourselves as a replacement for one. "Part 11 aware" means our architecture reflects the underlying principles of electronic records and electronic signatures — audit trails, time-stamped records, user authentication, access controls, and data integrity safeguards. For systems that genuinely require Part 11 validation under FDA scope (regulated EDC, eCRF capture for submission-grade data), you should be running a validated platform like the ones referenced in our platform strip, with a validation package executed by a qualified GxP validation partner. Our role is operational orchestration around those systems, not replacement of them.
Is OrenHealth a CRO, and can it replace one? +
No. OrenHealth is not a Contract Research Organization. We do not provide regulatory submission services, monitoring, GCP-certified clinical data review, query resolution under GCP, medical writing, biostatistics, pharmacovigilance, or any service that requires GCP-credentialed staff. CROs deliver clinical operations as a service against a regulated framework; OrenHealth delivers operational infrastructure and workflow tooling that complements that work. For sponsor-side studies the relationship is typically additive to your existing CRO, not a substitute.
How is participant PHI and IRB-protected research data handled? +
For HIPAA-covered participant data, we operate under an executed BAA aligned to HIPAA Privacy and Security Rule requirements — encryption in transit and at rest, audit logging, role-based access, breach notification posture. For IRB-protected primary research data captured under a study protocol, our position is that data stays inside your validated EDC or institutional research environment under your IRB-approved data management plan. We orchestrate operational workflow around that data, but we are not the primary system of record for regulated study data. Participant identifiers we do handle in operational workflow (contact info for visit reminders, recruitment outreach) are scoped, contractually defined, and BAA-covered.
What about GCP and ICH-E6 — are you certified? +
Our team is aware of GCP and ICH-E6 R2/R3 framework requirements but we do not market individual GCP certifications, and OrenGen Worldwide does not provide GCP-credentialed clinical research staff. When an engagement requires GCP-credentialed work — clinical data monitoring, query resolution, source-data verification — that work goes to your CRO, in-house clinical operations team, or contracted GCP-certified personnel. Our team supports operational and technical workflow that does not require GCP credentialing.
Can you build participant-facing AI that interacts with patients during a study? +
Operational and administrative communication only — visit reminders, scheduling, retention outreach, study-completion handoff. Any participant-facing AI that would constitute clinical advice, symptom triage, adverse event intake, unblinded study communication, or anything else that intersects with the conduct of the study under the protocol is explicitly out of scope. Participant-facing AI in regulated clinical research is a category that typically requires sponsor sign-off, IRB review of the specific AI tool, and in some cases FDA premarket consideration depending on intended use. We do not undertake that without all three.
Do you support real-world evidence, patient registries, or post-market surveillance work? +
Real-world evidence and registry projects are within scoping discussion for the operational orchestration layer — participant outreach, data collection workflow around a registry instrument, longitudinal communication. The registry instrument itself — case report forms, structured data capture, regulatory submission packaging — sits inside a validated platform with a study-specific data management plan. We are positioned to support the operational shell around a registry, not the registry's regulated data capture engine.
What does pricing look like for an investigator-initiated study versus a multi-site sponsor engagement? +
Pricing is confirmed in the Statement of Work after the research briefing — we do not publish list pricing because scope, integration complexity, and study volume vary significantly. Investigator-initiated studies typically engage on a defined-scope pilot for operational workflow (recruitment, scheduling, retention) with a fixed implementation fee plus monthly recurring infrastructure fee. Multi-site sponsor engagements engage on a master agreement structured around the operations layer, scoped to be additive to your existing CRO and validated platform stack. We do not gate the briefing or capability statement on pricing disclosure.
Open a Research Briefing

The fastest path forward is a 30-minute conversation.

Principal investigators, research directors, and sponsor-side operations leaders engage OrenHealth through a 30-minute briefing. Scope, BAA terms, regulated-versus-operational boundary, and what is explicitly out of scope are confirmed in writing before anything ships.

Schedule the Briefing Request the Capability Statement

OrenGen Worldwide LLC · UEI RX16QFYT6YM5 · CAGE 12XC1 · Minority-Owned Small Business · HIPAA-Aligned Architecture · BAA Ready · 21 CFR Part 11 Aware