Clinical Operations

Take one step closer to ClinOps maturity in your team

The way we work has fundamentally changed

The way we work has fundamentally changed. With teams more geographically dispersed than ever before, the tools we have relied on are no longer sufficient. Upgrade your digital workplace and empower people to work where they’re most productive—without compromising on quality or compliance.

Trusted by thousands of ClinOps professionals globally

Top clinical operations leaders leverage Montrium to hit their goals

Monitor team productivity

Gain visibility into your entire team's activity and drill down into individual studies

Identify potential blockers that impact milestones earlier

See collaboration as it happens in the system in real-time

Be in total control with complete oversight

Ensure content is filed correctly and quality metrics are maintained

Stay informed about bottlenecks that may impact team productivity

Adjust study parameters like milestones, countries, and sites as changes happen

Ensure you're aligned with objectives 

Report on key KPIs like completeness, quality, and timeliness of TMF filing

Deliver feedback to management
on team progress

Work better with study stakeholders to ensure good TMF practices

We realized very early on that to scale our Phase II successes in the next step of our journey, bringing in the appropriate technology to support this activity would be key. By partnering with Montrium, we not only leverage a sophisticated and robust eTMF system, but a knowledgeable and dedicated partner in the clinical trial arena.

Amy Emerson

Lykos Therapeutics

Packed with tools for the entire ClinOps team

Electronic monitoring visit reports
Study inbox for artifact collection
Reconciliation management
Investigator & contact management
Electronic TMF plans & indexes
Real-time TMF completeness
Automatic task distribution 
Placeholder management
Intelligent metadata management 
Batch upload & auto-index 
Pre-defined workflows per artifact
Investigator & contact management 
Role & access management 
Intelligent reporting & dashboards 
Central records center for archiving 
Inspection readiness tools 
Baked-in compliance 
Full audit trails & version control 
Inspector-specific dashboards & views

Top resources for clinical operations

White Paper
Clinical Operations
Building a Risk-based TMF Management Framework
In this first-of-its-kind white paper, Montrium's experts detail their new methodology for risk-based TMF management. It goes beyond simply explaining the theory behind risk-based approaches to providing worked examples that illustrate how you can implement this model within your own organization.
Clinical Operations
The State of TMF Industry Report 2023
The State of TMF Industry Report 2023 is the largest report of its kind, featuring proprietary data collected from 245 TMF professionals and analyses from Montrium's seasoned experts.
Clinical Operations
Guide to Sponsor vs CRO-owned TMF Systems
Our free guide breaks down the advantages and disadvantages of owning a sponsor eTMF system vs a CRO-owned eTMF system.
Clinical Operations
eTMF Request-for-Information Template
Our free RFI template helps get all of the critical criteria you need to evaluate eTMF software vendors.
Clinical Operations
Guide to Bringing TMF Management In-House
Discover what it takes to get from A-to-Z and manage your TMF internally with our free guide.
Clinical Operations
The Complete Guide to Buying eTMF Software
This guide will help select the right eTMF solution for your team with expert guidance and advice.
Clinical Operations
The Ultimate Checklist for Inspection Readiness
Our TMF checklist will provide you with a clear action plan as you prepare for your inspection.
Clinical Operations
COVID-19 and TMF Management Report 2020
The report includes the results of our COVID-19 and TMF Management Survey, with views representing a wide range of industry stakeholders, including pharmaceutical and biotech sponsors, and CROs.
Clinical Operations
eTMF Business Case Template
Build a powerful business case internally for implementing an eTMF at your organization with our FREE template!
Clinical Operations
Template - Paper-based System Cost Calculator
Our customizable Paper-Based System Cost Calculator lets you input a few basic metrics, and in minutes can tell you the total annual cost of your paper-based system.
Clinical Operations
eTMF Implementation Planning Workbook
This checklist has been designed as a self-guided preparation workbook to help your company plan a successful eTMF implementation.
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