# Avenio — Intelligent Protocol Hub for Clinical Teams > Avenio is an AI-powered clinical protocol platform for pharmaceutical, biotech, and life sciences organizations. It combines intelligent drafting, real-time collaboration, automated risk detection, and 21 CFR Part 11-compliant e-signatures into a single end-to-end workspace. Avenio is built on 12,000+ clinical protocols and 70 billion+ clinical data points. It helps clinical teams author, review, amend, and approve study protocols faster without compromising on science or regulatory compliance. Website: https://www.avenio.ai Contact: hello@avenio.ai Request a demo: https://www.avenio.ai/join-protocolhub --- ## What Avenio Does Avenio's Protocol Hub is a multi-tenant SaaS platform that centralizes every stage of the protocol lifecycle: 1. **Draft** — AI-assisted protocol authoring from scratch or from a company template 2. **Collaborate** — Real-time multi-user editing with inline comments, @-mentions, and threaded discussions 3. **De-risk** — Automated risk detection surfacing potential issues in inclusion/exclusion criteria, endpoints, and statistical assumptions 4. **Amend** — Structured amendment workflow with tracked changes, version history, and diff view 5. **Query** — Protocol query management for resolving open questions before database lock 6. **Approve & Sign** — Multi-step approval workflow with 21 CFR Part 11-compliant electronic signatures --- ## Core Features ### Protocol Authoring - AI-generated first draft from a brief or from the company knowledge base - Section-by-section structured editor with real-time auto-save - Template library drawn from historical protocols - DOCX export for regulatory submission - Version history with full audit trail ### AI Drafting (AvenioGPT) - Context-aware AI assistant embedded directly in the protocol editor - Three intelligence tiers: Avenio Fast, Avenio Standard, Avenio Deep - Ask questions about the protocol, request rewrites, surface risks, or generate content - Understands the full protocol context — not just the current section - Grounded in the company's own uploaded knowledge base and historical protocols ### Protocol Amendments - Structured amendment lifecycle: Draft → Review → Approved → Final - Tracks what changed between protocol versions with inline diff attribution - Amendment reason captured at every edit for audit trail (21 CFR Part 11) - Multi-section lazy loading for large protocols - DOCX export of the amended protocol ### Query Management - Create, assign, and resolve queries tied to specific protocol sections - AI-assisted query detection — flags potential questions before they become issues - Query status tracking (Open → In Progress → Resolved) - E-signature gate: queries must be resolved before the protocol can be locked - Full query audit trail ### Real-Time Collaboration - Multiple users can edit the same protocol simultaneously - Presence indicators show who is active in each section - Inline commenting with @-mention notifications - Threaded discussion threads on any section or paragraph - Change attribution — every edit is tied to a named user and timestamp ### Risk Detection - Automated scanning of inclusion/exclusion criteria against regulatory guidance - Flags statistical assumptions, endpoint conflicts, and common protocol risks - Visual risk summary with severity levels (Critical, High, Medium, Low) - Inline risk callouts within the editor ### Electronic Signatures (21 CFR Part 11) - Draw, type, or upload signature - Captures signer identity, timestamp, IP address, and meaning/reason - Multi-step approval workflow with configurable role-based signing order - Immutable audit trail — signatures cannot be altered or deleted ### Company Knowledge Base - Per-organization document library uploaded by admins - Feeds into AvenioGPT for company-specific protocol context - Supports SOPs, reference protocols, regulatory guidelines, and study templates - Used for AI drafting, risk detection, and query suggestions ### Single Sign-On (SSO) - OIDC-based SSO via Avenio's Identity Provider (AuthID / avidp.avenio.ai) - Supports PKCE flow and per-tenant OIDC configuration - Enterprise SSO integration available --- ## Compliance & Security - **21 CFR Part 11**: Full compliance — audit trails, e-signatures, access controls, no hard deletes - **Multi-tenant isolation**: Each organization's data is schema-isolated in a dedicated database schema - **Role-based access control**: Protocol Author, Reviewer, Approver, Tenant Admin, Super Admin - **UTC timestamps**: All record timestamps stored in UTC with timezone info - **Immutable audit log**: Every action is logged and cannot be modified - **Data residency**: Hosted on Google Cloud Platform (GCP) --- ## Who Uses Avenio - Clinical operations teams at pharmaceutical companies - Biotech startups running Phase 1–3 clinical trials - Contract Research Organizations (CROs) managing multi-study protocol portfolios - Regulatory affairs teams preparing IND packages and amendments - Medical writing teams drafting and reviewing study protocols --- ## Pricing Plans ### Starter For small clinical teams. Includes up to 5 team members, AI protocol drafting, and real-time collaboration. ### Professional For growing teams. Includes up to 25 team members, advanced AI features, risk detection, and priority support. ### Enterprise For large organizations. Includes unlimited team members, dedicated AI instance, custom integrations, and 24/7 dedicated support. --- ## Frequently Asked Questions **What is a Protocol Hub?** A Protocol Hub is a central workspace where clinical teams author, version, collaborate on, amend, and approve clinical study protocols. Avenio's Protocol Hub adds AI-powered drafting and risk detection to this workflow. **Is Avenio compliant with 21 CFR Part 11?** Yes. Every data mutation creates an immutable audit trail entry. No records are hard-deleted. Electronic signatures capture user identity, timestamp, and stated reason. All authentication events are logged. **Can Avenio connect to my company's existing documents and SOPs?** Yes. The Company Knowledge Base feature allows admins to upload SOPs, reference protocols, regulatory guidelines, and templates. AvenioGPT uses these documents when generating drafts and answering questions. **Does Avenio support amendments?** Yes. Protocol amendments go through a structured lifecycle: Draft → Review → Approved → Final. Every change is tracked with diff attribution and a full audit trail. **What AI models does Avenio use?** Avenio offers three tiers — Fast (optimized for speed), Standard (balanced), and Deep (maximum reasoning). The underlying models are not exposed to end users — they are routed automatically based on the selected tier. **How does real-time collaboration work?** Multiple team members can edit the same protocol simultaneously. The platform shows live presence indicators, supports inline comments and @-mentions, and attributes every change to the user who made it. **Can I export protocols to Word?** Yes. Protocols and amendments can be exported to DOCX format at any time. **How is my data protected?** Each customer organization has a dedicated database schema — data is never shared across organizations. The platform runs on Google Cloud Platform with encryption at rest and in transit.