Unified clinical research platform

Run trials in one platform.

MAESTRO unifies CTMS, eTMF, QMS, intelligent workflows and AI agents — eliminating data silos so your scientists focus on discovery, not on stitching tools together.

Trusted by clinical operations teams across CROs, biotechs and academic centers

Cloud agnostic — deployable on every major provider

Amazon Web Services Canadian region — MAESTRO deployment target Microsoft Azure Canadian region — MAESTRO deployment target Google Cloud Canadian region — MAESTRO deployment target Oracle Cloud — MAESTRO multi-cloud deployment IBM Cloud Canadian region — MAESTRO deployment target DigitalOcean Toronto region — MAESTRO deployment target
Why MAESTRO

Use one or all. Best-of-breed modules. Integrated as a platform.

Stop choosing between fragmented point-tools and rigid suites. MAESTRO gives you composable modules that share a unified data layer, AI core, and audit trail.

Eliminate data silos

One source of truth across CTMS, eTMF, QMS & workflows. No more reconciling spreadsheets between teams.

Automate documentation

AI generates, classifies and validates docs — cutting manual effort by up to 60% while improving accuracy.

Built for compliance

Continuous checks against FDA, EMA and ICH guidelines with real-time regulatory updates and full audit trails.

Run trials end-to-end

Plan, execute and monitor every stage of the trial lifecycle — with predictive analytics to prevent bottlenecks.

Quality by design

Real-time monitoring automates quality event detection, root cause analysis and CAPA for full GxP compliance.

Insights that act

Turn fragmented trial data into AI-powered insights and customizable dashboards your team will actually use.

The MAESTRO platform

Powerful. Modular. Intelligent.

Industry-leading modules combined with AI-powered workflows. Start with what you need, expand as you grow.

CTMS

Clinical Trial Management System

Streamlined management of every aspect of your clinical trials — from study setup to financials.

  • Study and site management
  • Patient recruitment and enrollment
  • Budget tracking and financials
  • Regulatory compliance automation
Explore CTMS
CTMS module for Canadian clinical trials — site, study and subject management
eTMF

Electronic Trial Master File

AI-powered trial documentation that’s always inspection-ready.

  • Automated document classification
  • Regulatory compliance tracking
  • Smart document search
  • Audit-ready documentation
Explore eTMF
eTMF for Health Canada-compliant clinical trials with 21 CFR Part 11 e-signatures
QMS

Quality Management System

Comprehensive quality control and compliance — built into your daily workflows.

  • CAPA management
  • Deviation tracking
  • SOP and document control
  • Audit management
Explore QMS
Clinical trial QMS for Canada — deviations, CAPAs and audit readiness
Workflow

Intelligent Workflow Automation

Streamline operations with smart, no-code automation across modules.

  • No-code workflow builder
  • Cross-module automation
  • AI-powered task prioritization
  • Real-time progress dashboards
Explore Workflow
Visual workflow automation for Canadian clinical operations
AI Agents

Autonomous AI Agents

Specialized agents for the repetitive, error-prone tasks slowing your team down.

  • Document review and processing
  • Data anomaly detection
  • Automated correspondence
  • Predictive insights
Explore AI Agents
AI agents for Canadian clinical trials — protocol Q&A, safety triage, regulatory drafting
Measurable outcomes

The numbers behind unified clinical operations.

60%

Reduced documentation time

Automated processing and templates slash documentation overhead.

45%

Faster trial setup

Streamlined workflows accelerate trial initiation processes.

99.8%

Regulatory compliance

AI-powered validation ensures near-perfect compliance.

35%

Research productivity

Automate routine tasks so teams focus on innovation.

100%

Seamless integration

Unify all research operations in a single platform.

24/7

Real-time insights

Continuous monitoring and analytics for better decisions.

5+

Cloud providers

Deploy where regulation, cost and geography demand.

1

Source of truth

One unified data layer across CTMS, eTMF and QMS.

How it works

Cutting-edge AI on a robust data foundation.

Our platform integrates AI with rigorous data management for a comprehensive solution that adapts to your needs.

MAESTRO platform architecture for Canadian clinical trials

AI Core Technology

Specialized models for document processing, NLP, anomaly detection and analytics — continuously learning while staying compliant.

Unified Data Layer

Centralized repository that maps relationships between trials, documents, quality events and metrics — killing silos for good.

Integration Capabilities

Pre-built connectors, REST APIs and adapters for clinical data standards with comprehensive audit trails out of the box.

Cloud agnostic

Deploy MAESTRO wherever your data needs to live.

Choose the provider, region and topology that fits your regulatory, cost and geographic constraints — without vendor lock-in.

Amazon Web Services Canadian region — MAESTRO deployment target Microsoft Azure Canadian region — MAESTRO deployment target Google Cloud Canadian region — MAESTRO deployment target Oracle Cloud — MAESTRO multi-cloud deployment IBM Cloud Canadian region — MAESTRO deployment target DigitalOcean Toronto region — MAESTRO deployment target

Deployment flexibility

Pick the cloud provider that best meets your regulatory, cost and geographic requirements.

Data sovereignty

Comply with regional data regulations by selecting the appropriate cloud regions.

Hybrid options

Operate seamlessly across public cloud, private cloud and on-premises environments.

Pricing

Plans that scale with your research portfolio.

From startups to enterprise programs — pick the engagement that matches your stage.

Startup

For biotech and early-stage companies

  • Essential modules access
  • Unlimited users
  • Standard AI capabilities
  • Basic integrations
  • Email support
  • Startup-friendly pricing
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Enterprise

For large pharmaceutical companies

  • Full platform access
  • Unlimited users
  • Custom AI model training
  • Enterprise integrations
  • Dedicated support team
  • Compliance validation package
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Need a custom solution?

Contact our team to design a tailored implementation that meets your specific research requirements.

Request a custom proposal
About MAESTRO

Built by scientists, for scientists.

MAESTRO was created by RAN BIOLINKS CANADA, a company founded by scientists with extensive clinical and research experience who recognized a critical problem in the industry: fragmented tools creating artificial data silos.

While numerous solutions exist in the market, we observed that their separation is primarily driven by business models rather than scientific needs. This fragmentation forces researchers to make difficult choices — either invest in multiple disconnected systems or sacrifice essential capabilities due to budget constraints.

Our philosophy is fundamentally different. We believe clinical scientists deserve a unified ecosystem where all tools work seamlessly together, allowing them to focus on breakthrough discoveries rather than managing disjointed software. MAESTRO embodies this vision — combining traditionally separate systems into one cohesive platform that puts scientists first.

MAESTRO — clinical trials platform built by scientists for Canadian sponsors and CROs
Built for every role

From protocol design to safety closeout.

MAESTRO doesn’t replace your team. It removes the duct-tape between Word docs, spreadsheets, EDCs and email — so each role can spend their time on the work only they can do.

Design
MD

Medical Director

Protocol & medical strategy

Designs protocols that survive ethics review and stand up to amendments. Wants prior-study answers in seconds — not weeks of digging through SharePoint.

Submit
RA

Regulatory Affairs Lead

Health Canada, FDA, EMA filings

Builds CTA dossiers and ICH-aligned submissions. Needs every document version-controlled, signed, and traceable — not scattered across email and shared drives.

Lives in
Execute
CO

Clinical Operations Manager

Portfolio planning & vendors

Plans timelines, vendors and budgets across a portfolio of trials. Wants one live dashboard for every study, every site — not seventeen weekly status calls.

Deliver
PI

Principal Investigator

Site delivery & patient care

Treats patients and runs the study at the site. Wants admin work — visit windows, queries, source data — to disappear so clinical focus stays on people.

Lives in
Coordinate
SC

Study Coordinator

Site operations, day to day

Holds the site together: visits, queries, source docs, IP accountability. Needs shortcuts that never break GCP — and a system that doesn’t require triple data entry.

Lives in
Monitor
CR

Clinical Research Associate

Remote & on-site monitoring

Monitors a portfolio of sites. Wants pre-visit briefs auto-prepared, deviations surfaced before they grow, and report time cut in half.

Comply
QA

Quality & GxP Manager

Audit readiness & compliance

Owns audit readiness. Needs every action timestamped, signed and reproducible — so when an inspector arrives, the answer is one click away, not a week of prep.

Lives in
Report
PV

Pharmacovigilance Lead

Safety, SAEs & narratives

Owns the SAE clock. Needs structured cases, regulator-ready narratives drafted in minutes, and an audit trail proving every step was on time.

Frequently asked

MAESTRO for Canadian clinical trials — answered.

From PIPEDA and Health Canada to ICH E6 R3 and bilingual Quebec studies — the questions Canadian sponsors, CROs and academic centres ask us most.

What is the best clinical trial management software in Canada?

MAESTRO is a Canadian-built, AI-powered clinical trials platform that unifies CTMS, eTMF, QMS, workflow automation and AI agents in one system. It is designed around Health Canada regulations (GUI-0104, GUI-0029), PIPEDA and provincial privacy laws (PHIPA in Ontario, Loi 25 in Quebec, HIA in Alberta), and ICH E6 R3 Good Clinical Practice — making it a fit-for-purpose alternative to legacy Veeva and Medidata stacks for Canadian sponsors and CROs.

Is MAESTRO compliant with PIPEDA and Canadian data residency requirements?

Yes. MAESTRO can be deployed in Canadian regions of AWS, Microsoft Azure, Google Cloud, Oracle Cloud, IBM Cloud and DigitalOcean. Personal information is processed in accordance with PIPEDA and applicable provincial laws (PHIPA, Loi 25, HIA), with audit logging, role-based access and breach-notification workflows built in.

Does MAESTRO support Health Canada Clinical Trial Application (CTA) submissions?

Yes. The eTMF and QMS modules are pre-configured with the document types, sectional structures and quality records required for Health Canada CTAs and amendments. Workflows trigger required reviews, e-signatures and notifications so submission-ready bundles can be exported on demand.

Is MAESTRO 21 CFR Part 11 and ICH E6 R3 ready?

Yes. MAESTRO provides 21 CFR Part 11 e-signatures, audit trails and computer system controls, and is designed against ICH E6 R3 principles (risk-based quality management, sponsor oversight, data integrity) — with validation packages (IQ/OQ/PQ) aligned to GAMP 5 available to customers.

How does MAESTRO compare to Veeva Vault, Medidata Rave or Oracle Clinical?

MAESTRO is a unified, modular alternative built for Canadian and mid-market sponsors. Instead of stitching together multiple enterprise tools, you get CTMS + eTMF + QMS + workflow + AI agents in one platform — at a fraction of enterprise pricing, with Canadian data residency and bilingual (English / French) support.

Is MAESTRO suitable for academic clinical research centres in Canada?

Yes. MAESTRO offers academic-discount pricing for university hospitals, research institutes and the Clinical Trials Ontario / 3CTN ecosystem, and provides simplified workflows for investigator-initiated and Phase I–IV studies.

Does MAESTRO support bilingual (English / French) clinical trials in Quebec?

Yes. MAESTRO’s UI, document templates and workflow notifications support English and Canadian French, in line with Quebec’s Loi 25 and the language-of-work requirements common to Quebec-based research sites.

How long does MAESTRO implementation take for a Canadian CRO or sponsor?

Most Canadian customers go live within 4–8 weeks. Implementation includes data migration, validation evidence (IQ/OQ/PQ aligned with GAMP 5), Health Canada-aware configuration and team training in English and French.

Ready when you are

Run your trials in MAESTRO.
Schedule a demo today.

See how MAESTRO can transform your clinical operations. Schedule a personalized demo with our team to explore the platform’s capabilities and discuss your specific needs.

Book your discovery call