We put the 'readiness' in inspection readiness

The key to a healthy TMF is simple: you need to know what’s going on. On a periodic (monthly, quarterly, bi-annually, annually) or adhoc basis, our TMF experts can review your TMF's overall health, perform quality checks and evaluate your inspection readiness state. Armed with inspection data from all regulatory agencies, we'll help point out exactly where the TMF quality, TMF completeness and timeliness issues may lie.

The TMF Health Check is a supportive and proactive inspection readiness tool to help you zero in on areas of your TMF process that require extra attention. Whether you have an inspection date upcoming or you're just looking to identify issues proactively, TMF Health Checks give you the invaluable insights that would take your team months to find.

TMF Health Checks include a full review of trial documentation, performing a focused TMF audit of a specific section of your clinical trial documentation such as a high enrolling site, a critical country etc. We'll provide you with a comprehensive report that contains the following:

• eTMF Health Status report
• TMF Cross Checks log
• TMF Quality issues log
• Good Clinical Practice (GCP) findings log
• Queries log
• CAPA Remediation log

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Sponsors who choose to outsource TMF management to CROs still have an obligation to perform proper oversight. This ongoing obligation can be a challenge for smaller sponsor teams who are dedicating their resources to study execution. Montrium's TMF Oversight services help alleviate the burden of sponsor responsibilities and CRO oversight by performing TMF oversight activities on a regular basis. We'll review and generate key metrics coming from your eTMF system, evaluating tmf inspection readiness at the study level.

Trial Master File (TMF) Oversight services are typically provided on a monthly or quarterly basis and a formal oversight report is provided at agreed intervals. These regular reports not only provide you with the insights to address issues quickly, but evaluate improvement over time.

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Telling the right story to the regulatory agency of what's happened in your clinical trial isn't a walk in the park. Navigating through thousands of essential documents, your tmf audit trail, the TMF reference model is not only incredibly time consuming for an inspector but . This can often be even more troublesome should they request remote access.

Montrium's trial master file services teams have helped clinical trial teams at CROs, sponsors and academic institutions properly prepare for inspections by supporting the development of storyboards.

Storyboards help you boil down your company's unique drug development journey into segmented positive stories that help craft a clear and concise narrative on the events that happened in your clinical trial. These frameworks, when created properly, also provide a clear and consistent message to align your team to prior to an inspection.

If you're looking to tell a better story in an inspection, reach out to our team today to book a consultation.

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Want to breeze through your next inspection? We can help.

We design mock inspection and mock audit environments that mimic the real thing. Using our inspection frameworks, our team will help simulate the steps an inspector would go through as they carry out TMF inspections.

We'll put your team through their paces, zeroing in on issues with tmf documents, missing essential documents, investigator site file (ISF) reconciliation anomalies, tmf completeness, tmf reference model implementation and much more. Using the reports and mock inspection findings we'll provide you, you'll have the insight and guidance on what to fix before the real thing.

If you've got a regulatory inspection upcoming soon, reach out to our team to see how we can help you cruise through with flying colours.

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Our roster of subject matter experts is available to help you solve problems and inspire improvements in any domain of your TMF environment. We’ve cultivated a team of passionate, innovative specialists who live and breathe TMF and inspection readiness—and who pride themselves on finding solutions to even the trickiest of issues related to trial master files.

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Are you looking for a complete inspection readiness solution? Need help defining a continuous process for audit trail review? Or just need to get a better handle on how to prepare sponsor tmfs in the eTMF systems you use?

Our TMF services team can help!

We've helped lean clinical and TMF teams at many organizations across the world to implement better trial master file programs. Based on your goals, we'll design a tailored inspection readiness program to help put your team in the best possible position when an inspection comes knocking.

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