AI-powered TMF services for inspection readiness

Transform TMF oversight from last-minute fire drills into continuous inspection readiness through AI-powered analytics and senior clinical expertise.

Managing clinical operations means balancing documentation, shifting regulations, and limited resources, all while trials need to move faster.

That’s why clinical teams reach out to learn how Montrium can help with:

Inspection readiness that fits into daily work instead of adding to it
Risk-based oversight that helps focus on what matters most
AI-powered augmentation that automates repetitive tasks, freeing your team to focus on strategic oversight and critical decision-making

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Enhance Inspection Readiness, Every Day, by Design

Replace fire drills with continuous readiness

Stressful, resource-intensive fire drills precede each audit. Instead, maintain your TMF in a state of perpetual inspection readiness.

Move beyond reactive responses to strategic prevention

Traditional manual TMF management keeps you in constant response mode. Transform it into a proactive, risk-based strategy that prevents.

Uncover hidden risks before they become problems

Manual auditing techniques can't uncover the compliance gaps and quality issues lurking in your TMF data. AI-powered analysis reveals these hidden risks before it's too late.

Everything Your TMF team Needs to Stay Inspection-Ready

✓ Trial diagnostic
Evaluate your trial plans and procedures against compliance requirements from day one. Identify potential gaps and risks early, before they impact trial timelines or quality.

✓ Risk assessment
Based on the diagnostic, establish a clear risk profile and strategy for your trial. This allows focused analysis on the areas that matter most, reducing the chance of surprises during inspections.

✓ Automated compliance review
Leverage AI to review your TMF for compliance with regulations, protocols, study plans, and SOPs, efficiently identifying any discrepancies.

✓ Corrective action plan
Receive a comprehensive summary of risks and issues with proposed corrective actions and visual storyboards. Know exactly what to fix and how to prevent future issues.

✓ Secure data handling
All data is processed in a secure, compliant environment with strict confidentiality protocols. We only work with exported data through secure channels, your sensitive information stays protected.

✓ Works with your existing eTMF
No complex integration needed. Our service complements your current system by analyzing exported reports and audit trails, delivering advanced analytics without disrupting workflows.

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Our AI-driven approach

TRIAL DIAGNOSTIC

Compliance gaps in trial plans are identified

Uncover risks early by evaluating trial plans and procedures against compliance requirements. This gives you a clear view of where potential issues may arise, before they impact trial timelines.

RISK ASSESSMENT

Develop a clear, risk-based trial plan

Leverage AI to continuously scan your TMF against regulations, protocols, study plans, and SOPs. Automated checks highlight discrepancies faster, saving your team time and reducing the chance of surprises during inspections.

COMPLIANCE

Automated TMF review for compliance gaps

CORRECTIVE ACTION PLAN

Summary of risks and issues

Get a clear picture of outstanding risks with proposed corrective actions and visual storyboards. This makes it easier to align teams, prioritize fixes, and communicate progress with confidence.

Getting Started is Easy

Free C

We align on your goals, timelines, and specific challenges in a brief initial consultation. You'll understand exactly how our service fits your trial needs and what to expect throughout the process.

Data provision

Provide us with key trial documentation like protocols and study plans, along with exported data from your eTMF, or grant us direct access to your system. Our team handles the rest securely.

Rapid diagnostic

Receive your initial Trial Diagnostic within 3-5 days. Get immediate, actionable insights into compliance gaps, hidden risks, and priority areas for your team to address.

Industry Leadership. Proven Expertise. Human-First Thinking.

✓ Industry standards leadership
We're at the table where industry standards are written. Our leadership helps define the TMF frameworks and eTMF specifications that organizations follow.

✓ GCP & regulatory expertise
Senior consultants who've prepped organizations for inspections, built GCP-compliant frameworks, and understand what's needed for successful audits.

✓ Responsible AI innovation & governance
Our experts explore how AI can support clinical documentation, with human oversight and clear governance at the center. We test tools responsibly and determine where automation adds value without compromising compliance.

✓ Validated systems engineering
Engineers with deep experience in developing, deploying, and validating computerized systems for regulated clinical trials.

Stop the Fire Drills. Start with a Conversation.

Schedule a consultation with Donatella to explore how AI-powered TMF services can transform your oversight from reactive scrambling to proactive readiness.

Book a consultation