Loss 01
Documents restart from zero
Synopsis, protocol, CRF and SAP are written by different people in different tools, each re-deriving the same variables and endpoints.
Real-World Evidence · Automated Execution
From protocol to publication, on one platform.
IRA is Cliniv's end-to-end AI-powered platform that transforms the execution of Real-World Evidence (RWE) studies by intelligently orchestrating every stage of the research lifecycle — from protocol development to scientific publication.
Retrospective & Prospective RWE
Sponsor · CRO · Site
Human-in-the-loop by design
0+
RWE studies
0M+
Subjects
0K+
Sites
12
Lifecycle stages, one system
Real-World Evidence
Built for the discipline
Built for the discipline
of RWE.
Designed to accelerate evidence generation, IRA automates study design, data collection, validation, analysis, and reporting — enabling researchers and healthcare organisations to efficiently evaluate the safety, effectiveness, and real-world utilisation of medical products while ensuring quality, compliance, and operational excellence.
The execution gap
A retrospective or
A retrospective or
prospective study is not
one job. It's eleven handoffs.
The science is rarely the bottleneck. Time is lost between the steps — in re-keying a protocol into a CRF, in chasing a tri-party agreement, in reconciling a dataset that was never designed to answer the endpoint. IRA removes the seams, not the scientists.
Loss 02
Start-up runs on email
EC submissions and tri-party agreements move at the speed of the slowest inbox. Sites wait, and the study clock keeps running.
Loss 03
Data arrives unfit for purpose
Fields collected without endpoint mapping surface as queries, missingness and re-abstraction at exactly the wrong moment — database lock.
Loss 04
Evidence stalls after analysis
Tables are delivered, then SAR, CSR and manuscript are rebuilt by hand from the same outputs, three times, by three vendors.
The IRA lifecycle
One orchestrated
One orchestrated
study cycle.
Twelve stages, six phases, one continuous data spine. Every artefact inherits from the one before it — the endpoint defined in the protocol is the same object that shapes the CRF, drives validation, and reappears in the statistical report. Select any stage to see what runs, who owns it, and where a human signs.
Stage 01 / 12
Synopsis & Protocol
Study Intake
—
Select a segment or use the stage rail below
Execution state
A study,
A study,
in flight.
The ring is the map. This is the run. Every study on IRA carries a live execution record — which phase is moving, which module holds it, and which gate is waiting on a person. Nothing advances past a gate on its own.
4 human sign-off gates
Audit trail: on
What you are looking at
An illustrative RWE cohort mid-execution. Completed phases are sealed and versioned; the active phase shows its owning module.
Why it matters operationally
Study status stops being a status call. Sponsor, CRO and site read the same record, so nobody reconstructs progress from an inbox.
Where a person is required
Protocol sign-off, CRF and EDC release, database lock, and report approval. Four gates, each recorded against a named approver and a version.
The automation layer
Specialists, not a
Specialists, not a
general-purpose chatbot.
IRA is an orchestration system. Each automation module holds a narrow, auditable remit, works from the study's shared data spine, and hands its output to the next module as a structured object — never as pasted text. A program management module sequences the run and escalates when a decision needs a person.
Human-in-the-loop
Automation is the draft.
Automation is the draft.
Accountability stays human.
Automation never advances a study past a control point on its own. Every gate records who approved what, against which version, at what time — the record a sponsor QA team, an ethics committee, or an inspector will actually ask for.
Protocol sign-offMedical lead approves scientific design, endpoints and cohort definition before build begins.
CRF & EDC releaseData management confirms endpoint mapping, edit checks and validation rules before go-live.
Database lockQuery resolution and data quality review closed out by the sponsor before analysis is unblinded to the team.
Report approvalAnalytics and medical writing leads approve SAR, CSR and manuscript before release.
RWD analytics
Real-world data,
Real-world data,
read in real time.
IRA's RWD platform provides real-time post-market safety insights that accelerate clinical development and strengthen market access. Analysis does not wait for lock — as records are captured, IRA converts Real-World Data into live cohort views. Illustrative views below use a dry eye disease cohort.
Age vs OSDI score
Scatter · least-squares trend
- Age mean
- 41.77
- Age median
- 40.00
- OSDI mean
- 15.73
- OSDI median
- 15.00
Each point is one patient. The dashed trend line is fitted live as records arrive — here it shows OSDI (symptom burden) tending to ease with age in this cohort, a relationship IRA surfaces automatically rather than waiting for final analysis.
Severity vs OSDI score
Min · median · max, by group
- Moderate n
- 28
- Severe n
- 38
- Mild n
- 27
- Total n
- 93
Min, median and max OSDI score within each clinician-assigned severity tier. The severe group's ceiling (48) sits well above mild's (19) — an early cross-check on whether clinical severity grading and patient-reported burden agree, before lock.
Occupation vs severity of dry eye syndrome
Cross-tabulation heatmap · n = 212
| Occupation | Mild | Moderate | Severe | Total |
|---|
Case concentration
Low → High
Desk and office roles carry the largest case volume (90 of 212), while field and outdoor roles show the highest proportion of severe disease (34 of 66). The kind of signal that reshapes a sub-group analysis before lock, not after.
Platform architecture
Built to be configured,
Built to be configured,
not customised.
Multi-tenant by design, with hard workspace isolation per sponsor and per therapeutic programme. Three layers keep the science flexible while the engine stays common — so a new study is a configuration, not a rebuild.
Layer 01
Core engine
The shared spine every study runs on. Versioned, validated once, inherited everywhere.
- Automation orchestration and task routing
- Study data model and endpoint registry
- Immutable audit trail and e-signature
- Role-based access across sponsor, CRO and site
Layer 02
Configuration layer
Where a study becomes yours — without touching code or forking the platform.
- Protocol and CRF templates per therapy area
- Approval chains and sign-off matrices
- Edit checks, derivations and validation rules
- Branded workspaces, e.g. ira.cliniv.in / your-programme
Layer 03
Extension layer
Connective tissue for the systems your evidence function already runs on.
- CTMS and EDC interoperability
- Structured exports aligned to CDISC / SDTM
- Terminology mapping — ICD, CPT, LOINC
- Analytics and safety-signal downstream feeds
Regulatory posture
Designed for the evidence to survive review.
IRA is engineered against the controls sponsors are asked to demonstrate. Compliance is a property of the deployment and the study, and is confirmed per engagement — never assumed.
21 CFR Part 11 — audit trail & e-signature
ICH-GCP aligned processes
HIPAA-aware safeguards
CDISC / SDTM-ready exports
EC / IEC submission packs
CDSCO-aware workflows
STROBE-aligned reporting
GDPR-conscious data handling
Role-based access control
Workspace-level data isolation
Versioned document lineage
Advantages for sponsors & sites
What changes on
What changes on
day one.
01
End-to-end automation
One orchestrated study cycle, from structure to close-out.
02
Simplified CTA execution
Tri-party agreements automated and tracked, not chased.
03
Rapid site onboarding
Sites activated in days rather than months.
04
Faster study set-up
Less set-up time, no duplicate entry, faster close-out.
05
Effortless data capture
Minimal physician time spent recording patient data.
06
Real-time study analytics
Live visibility into cohorts, progress and outcomes.
07
Predictive statistical reports
SAR output with built-in interpretive intelligence.
08
Sponsor decision dashboards
Demand signals and decision-ready views, on demand.
Who runs on IRA
Four seats at the
Four seats at the
same study.
Evidence generation fails at the boundaries between organisations. IRA gives each party its own view of one shared study record — with permissions that reflect how the work is actually contracted.
Sponsor
Medical affairs
Programme-level visibility across studies, decision dashboards, and evidence packages ready for market access and publication planning.
CRO
Delivery teams
Run multiple sponsor programmes in isolated workspaces, white-labelled, with the operational load of start-up and reporting compressed.
Site
Investigators & coordinators
Structured capture designed for retrospective abstraction and prospective collection alike — fewer fields, fewer queries, less unpaid administrative time.
Function
Analytics & medical writing
Analysis-ready datasets with documented lineage, and SAR, CSR and manuscript drafts that inherit from the outputs rather than restate them.
Business model
Three ways
Three ways
to engage.
Buy the platform, deploy it under your own brand, or hand the study to a Cliniv team running IRA end to end. Commercial structure follows how your evidence function is organised — not the other way round.
01
SaaS
Platform licence
Subscribe to IRA's full RWE workflow, deployed on your infrastructure or ours.
- Standard, Professional and Enterprise tiers
- Isolated workspace per programme
- Your SOPs configured, not rebuilt
- Named support and onboarding
02
White-label
Your brand,
our engine
Deploy IRA under your own identity — built for CROs and enterprise sponsors running evidence as a service.
- Full brand and domain control
- Multi-client tenancy with hard isolation
- Configurable approval chains per client
- Commercial terms structured per programme
03
Managed
Study-based engagement
A Cliniv IRA-powered team executes your RWE study, fully managed, end to end.
- Scoped per study, priced per deliverable
- Protocol through to manuscript
- Your medical lead retains sign-off
- Handover to platform licence at any point
Cliniv Health Tech
We build the systems
We build the systems
evidence runs on.
Cliniv Health Tech is a digital clinical research technology company working across trial digitisation, decentralised trials, EDC, CTMS and Real-World Evidence. IRA is our dedicated platform for retrospective and prospective RWE — the part of the evidence pipeline that has stayed manual longest, and costs sponsors most.
The team sits at the intersection of clinical operations, regulatory practice and applied AI. That combination is deliberate: an RWE platform that does not understand ethics submissions, database lock or medical writing is a demo, not a system of record.
Focus
Retrospective & ProspectiveProtocol to publication, one system
Deployment
Cloud or your VPCMulti-tenant with workspace isolation
Served
Sponsors, CROs, sitesMedical affairs and evidence teams
Presence
India · NepalSouth Asia-first, built for global programmes
Coverage
12 lifecycle stagesIntake through manuscript
Model
SaaS · White-label · ManagedConfigured to your operating model
See IRA in action
Bring us a study.
Bring us a study.
We'll show you the whole run.
A private demo walks one real retrospective or prospective question through every stage — intake to manuscript — on your therapy area, with your approval chain in place. Forty-five minutes, no slideware.