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Clinical AI-powered intelligence: Stay inspection-ready
Our Clinical AI Services apply powerful AI analytics to your eTMF data externally, uncovering issues and compliance risks that traditional processes miss.
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Built with remote teams in mind
Business process management with geographically dispersed teams can be challenging at the best of times. With remote working conditions here to stay, your teams need tools like ECM software that are specifically engineered to empower people to succeed from their home offices. Montrium has been developed to always centralize work on regulated content in one place with one version of the truth.
Looking for a solution for your remote team?
Built on ICH E6(R3) Principles
Risk-based oversight
Quality by design
Transparent study reconstruction
AI-Enhanced eTMF Services
Complete AI-driven TMF assessment with expert validation.
Study process diagnostic
Catch high-risk process gaps before inspectors do
Our AI-powered diagnostic assesses whether your critical processes align across protocol, SOPs, regulatory obligations, and CSR. It catches the gaps inspectors will question before you're sitting in the inspection, providing the process sufficiency evidence to respond with confidence.
Study Protocol Compliance
Ensure your TMF can defend every protocol-defined activity
The platform analyzes cross-document relationships to verify every protocol-defined activity, procedure, and endpoint is backed by clear, auditable evidence. This ensures your TMF withstands regulatory scrutiny and proves critical processes were conducted as designed.
Study SOPs, Plans, Manuals Adherence Check
Ensure operational documents tell one consistent story
We assess your SOPs, study plans, and manuals to find contradictions, procedural gaps, and outdated guidance that compromise study conduct. This evaluation ensures your operational documents form a coherent, compliant framework that withstands inspection scrutiny.
Study Oversight Evaluation
Show regulators you were in control throughout the study
We assess your sponsor oversight activities and documentation to verify you maintained control throughout the study. Inspectors expect clear evidence of monitoring, risk reviews, and vendor oversight. We confirm your documentation proves proactive, GCP-compliant governance that withstands regulatory scrutiny.
Study Audit Trail Review
Verify every eTMF action is authorized, traceable, and defensible
We analyze your audit trails to detect inconsistencies and verify appropriate authorization and traceability. This confirms your eTMF tells a trustworthy story where every action is documented, defensible, and demonstrates the data integrity controls regulators expect.
CSR Compliance
Ensure every CSR claim is backed by TMF evidence
We verify every CSR statement, analysis, and conclusion is backed by clear TMF evidence. When regulators challenge your results or question your methods, your TMF documentation provides the traceable proof that defends your submission.
How our AI-empowered service work
1. Diagnose
Our AI engine, trained on structured diagnostic models, validated risk patterns, and TMF expertise, performs a comprehensive assessment of your TMF's health against our diagnostic framework.
2. Risk assessment
Supported by AI, our TMF experts evaluate risk and score them per severity, allowing a more effective mitigation strategy.
3. Remediate
Our TMF team provide a prioritized, actionable report with clear recommendations to address identified risks and findings.
4. Monitor and continuous learning
We support continuous monitoring to ensure sustained TMF health and perpetual inspection readiness.
AI-powered, human-validated
Before any recommendation reaches your team, our senior TMF professionals validate every AI output, ensuring safe, accountable, and context-aware insights.
Safety you can trust
Every critical AI output is validated by human experts before any decisions are made.
Accountability built in
Clinical and compliance specialists assess risks, weigh trade-offs, and take the final call.
Contextual insight that counts
TMF professionals bring deep, experience-driven knowledge that AI alone can’t replicate.
"The AI augmentation has literally given me back hours in my week. Knowing where to focus my attention and my limited time is the key advantage to my daily work. Thanks to the whole team, especially Donatella, for delivering such an effective and time-saving solution."
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Compliance doesn't have to be a guessing game
Whether you're a CRO preparing TMF handoff or a sponsor facing inspection, Montrium’s AI-powered TMF intelligence gives you the proactive risk detection and clarity compliance teams need.
Frequently asked questions
Find answers to common questions about Montrium's AI Clinical Services.
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