Still facing challenges at inspection time, even with an eTMF system in place? We're here to help close that gap by upskilling your team with expert-led services and workshops. After all, knowledge is your inspection readiness power.
.webp)
Implementing the right eTMF technology is a crucial step toward compliance, but true success goes beyond the system itself. Through expert training and tailored workshops, we offer services designed to strengthen inspection readiness, minimize compliance risk, and build lasting operational excellence across your team.
Our TMF experts perform a targeted risk assessment of your Trial Master File processes to identify critical gaps, potential issues, and risk areas — then help you implement fit-for-purpose mitigation strategies that ensure quality and compliance throughout the trial lifecycle.
A unique, study-specific TMF risk management plan
Be ready to tell your story before the inspectors arrive with a clear, consistent narrative that connects your study milestones, decisions, and documentation — from first site activation to database lock. Learn exactly how to develop a study TMF storyboard that can be used to describe all aspects of a particular situation that occurred in a study.
The TMF Maturity Accelerator assesses where your organization currently stands on the TMF maturity curve. This service then helps you accelerate TMF maturity, embed quality by design, and build a roadmap to long-term compliance and operational excellence.
TMF maturity assessment with actionable recommendations
Learn how to perform smart, targeted TMF cross-checks that improve accuracy, reduce gaps, and build confidence in your TMF’s story.
The knowledge you need to perform ongoing cross-checks in your clinical trial study.
Whether you need to create a TMF plan from scratch or strengthen an existing one, our experts will help you build a TMF plan that sets the foundation for quality, compliance, and inspection readiness — right from day one.
Master or study-specific TMF plan
Let’s deep dive into your current TMF management approach using Quality by Design principles. We’ll evaluate structure, roles, workflows, and record lifecycle controls — identifying gaps, inefficiencies, and risks.
Process review report with recommendations for improvements
Learn to confidently perform record-level quality checks on real TMF documents from active clinical studies and assess compliance using ALCOA++ and GDocP principles.
QC’d records with clear examples of issues and how to remediate them.
Our TMF experts perform a targeted risk assessment of your Trial Master File processes to identify critical gaps, potential issues, and risk areas — then help you implement fit-for-purpose mitigation strategies that ensure quality and compliance throughout the trial lifecycle.
A unique, study-specific TMF risk management plan
Whether you need to create a TMF plan from scratch or strengthen an existing one, our experts will help you build a TMF plan that sets the foundation for quality, compliance, and inspection readiness — right from day one.
Master or study-specific TMF plan
Let’s deep dive into your current TMF management approach using Quality by Design principles. We’ll evaluate structure, roles, workflows, and record lifecycle controls — identifying gaps, inefficiencies, and risks.
Process review report with recommendations for improvements
Be ready to tell your story before the inspectors arrive with a clear, consistent narrative that connects your study milestones, decisions, and documentation — from first site activation to database lock. Learn exactly how to develop a study TMF storyboard that can be used to describe all aspects of a particular situation that occurred in a study.
The TMF Maturity Accelerator assesses where your organization currently stands on the TMF maturity curve. This service then helps you accelerate TMF maturity, embed quality by design, and build a roadmap to long-term compliance and operational excellence.
TMF maturity assessment with actionable recommendations
Learn how to perform smart, targeted TMF cross-checks that improve accuracy, reduce gaps, and build confidence in your TMF’s story.
The knowledge you need to perform ongoing cross-checks in your clinical trial study.
Learn to confidently perform record-level quality checks on real TMF documents from active clinical studies and assess compliance using ALCOA++ and GDocP principles.
QC’d records with clear examples of issues and how to remediate them.
You’re one click away from getting all of Montrium's award-winning content sent directly to your inbox
