eTMF features built for a better clinical trial

See what’s under the hood of eTMF Connect – the electronic trial master file software built by industry experts to take your clinical trial documentation to new heights. All eTMF Connect features are formulated through the lens that paper trial master files are mere passive repositories, while eTMF systems actively offer real-time study insights and built-in inspection readiness for clinical teams. This is the future. Get to market faster with our ever-evolving product features, because electronic trial master files are our bread and butter.

Document management features

eTMF systems like Montrium's eTMF Connect let you manage and upload documents faster than you could have ever imagined, all the while ensuring the compliance of your clinical study documents is up to inspection standards, so you don't have to.

Document template center & file plan

Accelerate and streamline the process of creating and filing clinical documentation with a dedicated template center and configurable file plan. Apply standard nomenclature to all documents you create or upload ensuring they're filed in the correct location.

Real-time collaborative authoring 

Remove friction in the authoring and review of TMF content a by leveraging real-time, collaborative authoring. Ensure your team is always working on the latest version and improve cross functional communication. 

Configurable review & approval workflows 

Dynamically drive the document lifecycle with centrally managed tasks, significantly speeding up the authoring of study documentation, document reviews and the filing of TMF content.  

Native integration with M365 & Office 

Do away with clunky file share systems and seamlessly connect your clinical environment to your operations with native Microsoft 365 and Office integration. 

TMF Reference Model support 

Launch your study from a pre-defined TMF structure that's fully aligned with the most recent version of the TMF Reference Model (formerly DIA reference model). Keep regulatory compliance in check while aligning with expectations from regulatory agencies.

Records center for eTMF archiving 

All final electronic trial master file records are stored in a secure centralized record center allowing review of the clinical trial documents by inspectors and auditors. 

21 CFR Part 11 & Annex 11 digital signatures 

Validated electronic signature technology ensures you're in compliance with 21 CFR Part 11 & Annex 11 when your team is signing records.

Built-in PDF conversion engine 

Speed up file conversion and avoid third party tools by leveraging a built-in PDF conversion engine. 

Google-like search & retrieval tools 

Make finding trial master file content as simple as looking up a nearby restaurant with Google-like search tools. Leverage detailed metadata and in-content search for the quick retrieval of records. 

Drag & drop in bulk and on to document placeholders 

Users can simply drag and drop files into the clinical inbox at the swipe of a mouse and index them later. 

Staging area for incoming documents 

Simplify data collection of site level documents from external stakeholders and allow them to send emails with attachments to study staging areas ready for indexing and filing. Managing clinical trial documentation made simple.

Batch indexing & auto-filing of eTMF content 

Reduce the time you spend indexing documents by using the bulk indexing tool, allowing you to specify common metadata before filing documents. 

Study management features

Montrium's eTMF software features take study management to the next level with a real-time vantage point onto the ins and outs of your study. From completeness reporting to insightful timeliness trends, life sciences companies around the globe are turning to eTMF Connect for actionable insights that make for better, faster, and stronger clinical studies.

Real-time access to TMF completeness reporting 

With the eTMF Navigator, you can get a visual view on real-time completeness based on study, country, and site milestones. 

Trend on timeliness of TMF filing

Understand what might be impacting the timeliness of your trial master files by identifying issues at the country, site, or staff level. 

Identify quality issues faster with reports 

Dig into what might be contributing to quality issues in your eTMF system, finding and remediating them before an inspector does. 

Manage study TMF plans & document indexes 

Create, manage, and save study TMF index templates to improve standardization and accelerate study startup. 

Directory of study information 

You can centrally manage site and investigator information along with milestone and status without the need for an in-house CTMS. 

CTMS-like study milestone management 

Throw out your Excel study tracker with our centralized study milestone management. An eTMF system feature to make managing your clinical trials a whole lot easier. 

Easy-to-train interface for inspectors 

Save time and reduce stress during inspections with an interface that’s intuitive and easy to train inspectors on.

Inspector portal to facilitate inspections 

Improve the clinical trial story you tell in inspections thanks to a dedicated inspector portal with robust access management and control. 

Built-in TMF archiving 

Avoid acquiring additional archiving software to house your completed studies. Store completed studies in our built-in archive, lock and control access while still making it easy for authorized staff to retrieve documents.

Dynamically build out study, country & site structure

Nail down which documents you’ll need at each milestone and have the eTMF system do the heavy lifting for you. 

Full audit trails & version history 

Go back in time to see all previous versions of documents with Integrated Document Versioning. A game changer in improving not only your audit trail, but your trial master file content and story.

Role restriction for all trial stakeholders 

Strategically control access and permissions with granular detail, providing a clean and optimized interface for study stakeholders. 

Investigator site file & site management features

eTMF solution features like dynamic placeholder management, site and investigator directories and centralized global contact documents are a few of many features to level-up your relationship with your clinical sites.

Create placeholders for site staff to upload content 

Never keep a site guessing again. Dynamic placeholder management provides clear instruction on what content you need sites to upload to the TMF in a timely manner. 

Built-in eISF repository for investigator sites 

Empower sites to store, manage, and access the content they’re required to store and contribute in one central restricted portal in the eTMF software.

Study inbox for batch emailing site content 

Clinical sites can email essential documents directly into the system without a need for a user account. 

Centrally manage global contact documents 

Ensure that there is only one single source of truth in your eTMF system. Upload documents that are program or contact level once, and associate to relevant studies. 

Directory of sites & investigators 

You can centrally manage site and investigator information and status without using a CTMS. 

Integrations with other site systems 

Streamline and centralize all of your processes with custom integrations to make system-to-system communication easier. 

Electronic generation of MVRs for remote monitoring 

On-site visits might not yet be a thing of the past, but printed visit reports now are. Empower monitors to author and complete MVRs directly in the system for full visibility until final. 

Restrict site access to their site portal 

Carefully control access across your study for external parties, providing the right information to the right sites at the right time. 

Export data to Excel for further reporting 

Export your TMF data to Excel for easy analysis, reporting, and sharing of the information that stakeholders need to see.  

Administration, security &compliance

Yes, built in TMF compliance is possible! our eTMF solution is continuously updated to ensure compliance is met across the board, without needing to lift a finger. Consider it the ultimate
inspection-readiness hack. 

Built with GCP & industry best practices 

Stay consistently aligned with GCP and industry best practices thanks to an eTMF that’s built on them.   

Aligned with the TMF Reference Model 

Pre-defined configuration is fully aligned with version 3.2. of the TMF Reference Model.

21 CFR Part 11 & Annex 11 compliant 

Ensure your records are compliant with 21 CFR Part 11 & Annex 11 compliant digital signatures.

Custom integrations available with other systems 

Streamline and centralize all of your eTMF systems processes with custom integrations to make system-to-system communication easier. 

Compliance with GDPR from the ground up 

eTMF system features and functionalities designed to help you achieve end-to-end GDPR compliance with ease. 

SSO & active directory integration 

Avoid frustrations with logins, security, and network administration thanks to SSO and active directory integration. 

Robust security & access management 

Robust security, access management and configurable user roles let you share what needs to be shared and protect what needs to be protected. 

QMS aligned with ISO standards

Our QMS has been thoughtfully aligned to the ISO standards for quality management systems ensuring you remain compliant with requirements from the regulatory bodies.

Advanced data export & content portability 

Take your data wherever you need it. Built in export functionality allows you to import content and data to be used across your organization with a few clicks.

Ready to run better clinical trials with an eTMF system built for emerging life sciences companies? 

See the Montrium eTMF in action in a live demo.

Built-in security & compliance

We take the responsibility of helping you manage clinical trial data seriously. That’s why security and compliance are key focus areas for our organization and product development.

Rapid implementation & validation

Implementing software in the life sciences industry has changed dramatically. Leverage our team of industry vets as we guide you from zero to eTMF hero in as little as 4 weeks.