The ClintHub AI Platform
One AI-native platform, built for the full clinical development lifecycle
ClintHub's platform starts with protocol development and is built to grow with the rest of the clinical development lifecycle.
Objectives & Endpoints
AI drafting…
Study Design & Population
Queued
Eligibility Criteria
Queued
Safety Monitoring
Queued
Statistical Considerations
Queued
AI-Powered Protocol Development
Clinical protocol development, reimagined
The AI-powered protocol development platform that takes clinical teams from study concept to a controlled, structured protocol — faster, without compromising scientific quality.
Platform Overview
Everything a protocol development team needs, in one platform
Study-Contextual Setup
Standardized Structure
AI-Assisted Authoring
Proprietary Knowledge Engine
Literature Integration
Automated Quality Review
Collaboration & Version Control
Enterprise Security
How It Works
One controlled environment, from concept to conduct
STEP 01
Study Setup
Begin with the study concept, not a blank page. Users create a protocol project and enter the core study information — indication, phase, investigational product, design, population, treatment groups, key objectives. Every downstream draft is anchored to this specific study.
STEP 02
Protocol Framework
ClinPro creates a structured protocol framework with every required section — objectives, endpoints, design, population, eligibility, treatment, assessments, safety monitoring, statistical considerations — plus your organization's own standards, built directly in.
STEP 03
AI-Assisted Authoring
The platform drafts individual protocol sections — like eligibility criteria — in minutes rather than days. The clinical scientist or medical writer reviews, edits, accepts, or modifies every line. Human-in-the-loop by design.
STEP 04
Proprietary Knowledge Engine
A retrieval-augmented generation (RAG) engine draws on approved knowledge sources — prior protocols, organizational standards, study data, curated content — while assisting protocol development. Institutional knowledge is reused in a controlled, auditable way.
STEP 05
Scientific Rigor
Relevant scientific literature surfaces directly inside the authoring workflow, supporting design decisions, population definitions, endpoints, and safety considerations with traceable evidence — no separate search.
STEP 06
Quality Control
An automated QC layer reviews content against predefined quality parameters, flagging inconsistencies, missing information, and areas needing attention before human review even begins.
STEP 07
Cross-Functional Teamwork
One controlled environment for clinical development, medical, statistics, operations, regulatory, and safety — replacing scattered documents and email chains with collaborative authoring and systematic version management.
STEP 08
Trust & Governance
Architected around enterprise security and role-based access control, with features aligned to 21 CFR Part 11 requirements where applicable. Data segregation built in.
STEP 09
Beyond Version One
The protocol doesn't stop being a living document once finalized. ClinPro supports the full lifecycle — concept, protocol development, clinical conduct, and every subsequent amendment — as one continuous record.
Proprietary Technology
A proprietary knowledge engine — not a generic AI tool
Generic AI tools generate responses without sufficient organizational or study-specific context. ClinPro's retrieval-augmented generation (RAG) engine draws on approved knowledge sources — prior protocols, organizational standards, study information, and curated content — while assisting protocol development.
For sponsors running multiple development programs, institutional knowledge is reused in a controlled, auditable way — not lost between studies.
Beyond The Protocol
Every core document, in one workflow
ClinPro doesn't stop at the protocol. It supports the full set of documents a clinical development program depends on — in the same controlled, study-contextual environment.
Study Synopsis
The condensed scientific summary of the trial design, drafted with the same study context and standards as the full protocol.
Investigator's Brochure (Abstract)
Key abstracted findings and safety data investigators need, kept consistent with the protocol.
Statistical Analysis Plan
Endpoint definitions and analysis methodology, aligned to the protocol's objectives and design.
Published Literature
Relevant literature surfaced and linked directly to the sections it supports, with traceable references.
Trust & Governance
Enterprise security, built for pharma and biotech
Speed matters — but confidentiality, data segregation, and compliance matter just as much. ClinPro is architected around enterprise security and role-based access control, with features aligned to 21 CFR Part 11 requirements where applicable.
ClinCRF
From a locked protocol to data-ready Case Report Forms.
Once a protocol is locked, every endpoint, assessment, and visit still has to become a Case Report Form by hand. ClinCRF is being built to close that gap — generating structured, protocol-aligned CRFs directly from ClinPro, so data management teams start from a validated draft instead of a blank form.
Planned Capabilities
Faster, more consistent, and better supported — never replaced
Faster
From concept to structured draft in a fraction of the traditional time.
More Consistent
Standards and quality embedded into every protocol, every time.
Better Supported
AI-assisted drafting paired with expert clinical development guidance.