CliProof — Clinical Research, Proven.

The Problem

Built for institutions.
Priced for outsiders.

Most clinical SaaS is built for organizations with full-time IT teams, six-figure budgets, and trial counts in the hundreds. CliProof is built for the rest of us — sites where the regulatory binder lives on someone's desk and "audit prep" means a long weekend.

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Enterprise CTMS Platforms

Built for organizations running 50+ trials — academic medical centers, large CROs, pharma sponsors. Months of implementation, six-figure annual contracts, and feature complexity small sites will never use.

$50,000–$500,000 / yr

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Spreadsheets & Paper Binders

No audit trail. No version control. No proof of ALCOA+ data integrity. One inspection finding puts sponsor relationships — and future trials — at risk.

Inspection failure risk

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Per-User CTMS

Site platforms that charge per seat. Adding monitors, CRCs, and sub-investigators triggers more billing — punishing the sites that grow fastest.

Costs scale with your team

How It Works

Every protocol moves through eight phases.
CliProof shows up at each one.

From the day the sponsor sends the protocol to the day the trial closes — fewer hours, fewer findings, more wins.

PHASE 01

Feasibility

CliProof IQ Score signals sponsor-grade quality. Pre-populated answers turn day-long questionnaires into one-hour responses.

Feasibility wins, faster turnarounds

Powered byCliProof IQ Score

PHASE 02

Site Qualification

Instant access to CVs, training records, SOPs, and lab certifications when sponsors arrive to qualify your site.

Days of prep → minutes

Powered byeTMF Document Management

PHASE 03

Contracting & Budget

Centralize protocol procedures and rate documents. Build budgets faster with a single source of truth.

No more scattered spreadsheets

Powered byeTMF Document Management

PHASE 04

Regulatory & IRB

Version control catches outdated documents before they reach active use.

Catches version mismatches before they become 483 findings

Powered byeTMF Document Management21 CFR Part 11 Audit Trail

PHASE 05

Site Initiation

Training records auto-linked to the active protocol version.

Auto-updates on every amendment

Powered byeTMF Document Management

PHASE 06

Conduct

Consent timing alerts, visit window tracking, source-document linking, deviation logs.

Every entry timestamped, attributed, and audit-ready

Powered byPatient Enrollment & Visit TrackingClinical Assessment Engine

PHASE 07

Monitoring

Monitor queries tracked through resolution. Source documents one click from each eCRF entry.

Source-document linking collapses query response time

Powered by21 CFR Part 11 Audit TraileTMF Document Management

PHASE 08

Closeout

One-click DIA TMF Reference Model–compliant archive.

Closeout TMF assembly compressed from days to hours

Powered byeTMF Document Management

The Solution

One platform.
Everything your site needs.

CliProof is audit-ready out of the box. From the first patient screen to final data lock — all in one place.

eTMF Document Management

TMF Reference Model compliant. Documents are immutable once finalized — only supersede, never delete. Sponsor remote monitoring access built in.

Role-Based Document Requirements

Most platforms track document expirations. CliProof tracks what each role requires. Assign a Clinical Rater — the system already knows they need PANSS, MADRS, and C-SSRS certifications. Assign a Sub-Investigator — CV, GCP, medical license, protocol training. The delegation log auto-generates from these assignments. IQVIA-standard, 22 delegated tasks, medically-qualified-task enforcement built in.

Clinical Assessment Engine

Any specialty assessment ready in days through configuration — no custom code. Live scoring updates as your CRC fills in each field. Starter library at every tier; full library (PASI, EASI, IGA, HAMD, RECIST, DAS28…) available on Growth and up.

21 CFR Part 11 Audit Trail

Every action attributable, contemporaneous, and immutable — ALCOA+ data integrity built in. Who changed what, when, from where. E-signatures with re-authentication. Inspection-grade evidence trail from day one.

CliProof IQ Score · Growth tier and up

Your site's real-time compliance score out of 100. Sponsors see it. It differentiates you from competing sites during feasibility assessments.

app.cliproof.com/dashboard

Site IQ Score

94 / 100

↑ 3 pts from last audit

Compliance

100%

Active Trials

Enrolled

↑ 8 this mo

Documents

284

All compliant

Phase 3 · Heart Failure · 80 patients

Enrolling

Phase 2 · Type 2 Diabetes · 45 patients

Screening

Phase 1 · Solid Tumor Oncology · 30 patients

IRB Pending

Site Intelligence

The drudgery, automated.

CliProof reads what's already in your audit trail, your site profile, and your regulatory binder — and does the work you'd rather not. Every output is reviewed and signed off by a human. Nothing autonomous, nothing opaque.

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Audit-ready narratives, in under a minute

Point at a patient, a document, or a date range. CliProof generates an inspection-grade timeline narrative from your audit trail. Every claim traces back to a specific logged event.

Replaces: the long weekend of audit prep before a sponsor monitor visit.

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Site IQ Score, explained in plain English

Your IQ Score is a composite of audit completeness, query response time, deviation rate, and document timeliness. CliProof tells you exactly why your score is what it is — and what to do about it.

Replaces: guessing why sponsors picked a different site.

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Sponsor RFI responses, pre-drafted

Upload a feasibility questionnaire. CliProof drafts 60–80% of the answers from your structured site profile — staff credentials, equipment, prior trial history, patient demographics. You review, edit, and submit.

Replaces: 4–8 hours per RFI, every RFI.

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Regulatory documents that re-use themselves

Upload a 1572, a GCP cert, a lab certification — CliProof identifies what it is, extracts expiration and scope, and links it to every current and future trial that needs it. Renewal alerts go out automatically.

Replaces: the spreadsheet tracking which docs expire when.

How it works under the hood

Every AI-generated output is reviewed by a human before it leaves CliProof. Models run inside our HIPAA-covered Azure environment — no patient data leaves your boundary. Every AI interaction is logged in your audit trail. CliProof's AI is built to assist your team, not replace your judgment. Site Intelligence ships with v1.0.

Specialties

Every specialty.
One platform.

From oncology to dermatology to cardiology and beyond — we add new specialties through configuration alone. Ready for your trial in days, with no extra development cost.

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Cardiology

Heart Failure · NYHA · MACE endpoints · Atrial Fibrillation

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CNS / Psychiatry

Depression · Alzheimer's · Schizophrenia · HAMD · MMSE · PANSS

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Dermatology

Atopic Dermatitis · Psoriasis · Hidradenitis Suppurativa · Alopecia Areata · Vitiligo

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Endocrinology

Type 2 Diabetes · Obesity · GLP-1 trials · HbA1c tracking · NASH

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Oncology

RECIST 1.1 · ECOG · NCI-CTCAE · Solid Tumors · Hematologic

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Ophthalmology

BCVA · OCT · Macular Degeneration · Diabetic Retinopathy

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Rheumatology

Rheumatoid Arthritis · DAS28 · ACR20/50/70 · Psoriatic Arthritis

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Any Specialty

Don't see your specialty? We add new ones through configuration — typically ready for your trial in days, with no extra development cost.

Compliance

Sponsors won't select a site they can't trust.

CliProof is built compliance-first. Every feature is designed to pass FDA inspection, not just to look good in a demo.

✓ Immutable audit log — every action recorded, nothing deleted, ever
✓ Re-authenticated e-signatures — Part 11 §11.200 compliant credential binding
✓ AES-256 encryption — keys managed in Azure Key Vault, tenant data isolated at the schema level
✓ Role-based access control — PI, CRC, Sponsor, Monitor see only what they should
✓ Automatic version control — supersede, never delete; full version history retained

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21 CFR Part 11

Electronic records & signatures fully compliant

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HIPAA

PHI encrypted at rest and in transit

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ICH-GCP E6(R3)

Current Good Clinical Practice guidelines built in

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DIA TMF v3.3

Industry-standard document structure

✓

ALCOA+

Data integrity principles enforced by design

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US Data Residency

Hosted in US Azure regions, no offshore storage

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Tenant Isolation

Schema-per-tenant data separation, AES-256 at rest

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TLS 1.2+

Encryption in transit — every connection secured end-to-end

Tiers

Designed for sites of every size.
Pick the tier that fits.

Simple. Transparent. No enterprise contracts.

Unlimited users on every plan. Pricing scales with your trials, not your team.

Month-to-month software subscription. No SaaS setup fees. Cancel anytime. Volume pricing available on request.

Closed and archived trials don't count toward your tier. Run as many studies over time as you want — only concurrent active trials affect pricing.

Starter

Unlimited users included

$599/mo

For solo investigators and small teams · billed monthly

For sites running 1–2 trials. Audit-ready out of the box — compliance baseline for any clinical research site.

✓Up to 2 concurrent active trials
✓eTMF document management (full DIA TMF Reference Model v3.3.1 — all 250 artifacts)
✓Role-based document requirements
✓TMF completeness & milestone readiness (see what's missing — inspection-ready at every study milestone)
✓Auto-generated delegation log (IQVIA standard)
✓Credential & document expiration tracking (see what's expiring before it lapses)
✓21 CFR Part 11 audit trail (INSERT-only, tamper-evident)
✓§11.200 e-signatures with re-authentication
✓Document immutability with version history
✓HIPAA BAA included
✓Standards-compliant TMF export (no vendor lock-in)
✓Self-serve onboarding

Get Started

Clinical research, proven.

Clinical
research,
proven.