MAESTRO Clinical Trials
Run clinical trials in one platform.
A unified CTMS, eTMF, eISF and QMS with intelligent workflows and AI agents — so research teams stop stitching tools together and focus on discovery.
- 5
- Modules in one platform
- 60%
- Less documentation time
- 1
- Unified source of truth
Stop choosing between fragmented tools and rigid suites.
Legacy clinical software forces a trade-off: stitch together point tools, or lock into an enterprise suite priced beyond reach. MAESTRO gives you composable modules on a shared data layer, AI core and audit trail.
Eliminate data silos
One source of truth across CTMS, eTMF, eISF, QMS and workflows — no more reconciling spreadsheets between teams.
Automate documentation
AI generates, classifies and validates documents, 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 dashboards your team will actually use.
Powerful. Modular. Intelligent.
Industry-leading modules combined with AI-powered workflows. Start with what you need, expand as you grow.
CTMS — Clinical Trial Management
Streamlined management of every aspect of your trials, from study setup to financials.
- Study and site management
- Patient recruitment and enrollment
- Budget tracking and financials
- Regulatory compliance automation
eTMF — Electronic Trial Master File
AI-powered trial documentation that is always inspection-ready.
- Automated document classification
- Regulatory compliance tracking
- Smart document search
- Audit-ready documentation
eISF — Electronic Investigator Site File
The site-side counterpart to your eTMF — every site's regulatory documents kept current, controlled and inspection-ready.
- Site-level regulatory document management
- Real-time eTMF ↔ eISF reconciliation
- Remote monitoring and sponsor access
- Delegation logs, CVs and training records
QMS — Quality Management System
Comprehensive quality control and compliance, built into daily workflows.
- CAPA management
- Deviation tracking
- SOP and document control
- Audit management
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
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
Cloud-agnostic deployment
Deploy where regulation, cost and geography demand — without vendor lock-in.
- AWS, Azure, GCP, Oracle, IBM, DigitalOcean
- Canadian region data residency
- Public, private or hybrid topologies
- Pre-built connectors and REST APIs
The numbers behind unified clinical operations.
Teams adopt MAESTRO to move faster, document less by hand, and stay continuously inspection-ready.
Built for Canadian — and global — clinical research.
Designed around Health Canada, PIPEDA and provincial privacy law, ICH E6 (R3) and 21 CFR Part 11 — a fit-for-purpose alternative to legacy enterprise stacks.
Health Canada aware
eTMF and QMS pre-configured for CTA submissions, amendments and required quality records.
21 CFR Part 11 & ICH E6 (R3)
E-signatures, audit trails and computer-system controls with IQ/OQ/PQ validation aligned to GAMP 5.
Canadian data residency
Deployable in Canadian regions across six cloud providers, with PIPEDA, Loi 25, PHIPA and HIA awareness.
Bilingual by design
UI, templates and notifications support English and Canadian French for Quebec studies.
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 spends time on the work only they can do.
Medical & Regulatory
Design protocols that survive ethics review and build ICH-aligned CTA dossiers with every document version-controlled and traceable.
Clinical Operations
Plan timelines, vendors and budgets across a portfolio with one live dashboard for every study and site.
Sites & Coordinators
Run visits, queries and source data without triple data entry — shortcuts that never break GCP.
Monitoring (CRA)
Auto-prepared pre-visit briefs, deviations surfaced before they grow, and report time cut in half.
Quality & GxP
Every action timestamped, signed and reproducible — so inspections are one click, not a week of prep.
Pharmacovigilance
Structured SAE cases, regulator-ready narratives drafted in minutes, and an audit trail proving timeliness.
MAESTRO Clinical Trials, answered.
Yes. MAESTRO can be deployed in Canadian regions of AWS, Azure, GCP, Oracle, IBM and DigitalOcean. Personal information is processed under PIPEDA and provincial laws (PHIPA, Loi 25, HIA), with audit logging, role-based access and breach-notification workflows built in.
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, with workflows that trigger reviews, e-signatures and notifications.
Yes. MAESTRO provides 21 CFR Part 11 e-signatures, audit trails and computer-system controls, and is designed against ICH E6 (R3) principles — with IQ/OQ/PQ validation packages aligned to GAMP 5 available to customers.
MAESTRO is a unified, modular alternative 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 support.
Yes. The UI, document templates and workflow notifications support English and Canadian French, in line with Quebec's Loi 25 and language-of-work requirements common to Quebec-based research sites.
Explore the rest of MAESTRO.
See MAESTRO Clinical Trials on your own operations.
Book a personalized walkthrough with our team. We will map your current tools, migration considerations and the fastest path to value.