eTMF Connect is built by TMF experts to give clinical teams real-time visibility into study documentation and inspection readiness. Browse the features below to see how each one reduces administrative work and keeps your TMF complete.
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.
Artifact linking
From within any artifact, link related documents across your study. Keep connections between protocols, amendments, and supporting records visible and traceable without hunting through folder structures.
Shared artifact
Re-use documents across studies without re-uploading them. Program-level or contact-level records stay in one place and associate to every relevant study, keeping your data clean and your team out of duplicate filing work.
External signers
Assign an external signer directly from the document timeline. No need to route documents outside the system; the signature request goes to the right person and the audit trail stays intact.
Reclassification
Change a document type directly in the system when a file lands in the wrong category. Fix indexing errors without disrupting the document timeline or losing audit trail history.
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.
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.
Do away with clunky file share systems and seamlessly connect your clinical environment to your operations with native Microsoft 365 and Office integration.
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.
Reduce the time you spend indexing documents by using the bulk indexing tool, allowing you to specify common metadata before filing documents.
Validated electronic signature technology ensures you're in compliance with 21 CFR Part 11 & Annex 11 when your team is signing records.
Speed up file conversion and avoid third party tools by leveraging a built-in PDF conversion engine.
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.
Users can simply drag and drop files into the clinical inbox at the swipe of a mouse and index them later.
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.
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.
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.
Set up blinded studies directly in the system. Unblinded users upload documents through the standard workflow; the system handles access controls, and lifting blindness follows a structured, auditable process when the time comes.
See every pending task across your study in one place. Filter by status, type, or assignee so nothing falls through the cracks and your team knows exactly what needs attention.
Register and track documents stored outside the eTMF without losing oversight of them. Signposts carry mandatory reference metadata, a full audit trail, and lifecycle visibility, so your completeness picture stays accurate even when documents live elsewhere.
See a real-time inventory of planned versus actual documents across your study, country, or site. Know instantly what is expected, what is filed, what is missing, and how complete each document type is without running a separate report.
With the eTMF Navigator, you can get a visual view on real-time completeness based on study, country, and site milestones.
Understand what might be impacting the timeliness of your trial master files by identifying issues at the country, site, or staff level.
Create, manage, and save study TMF index templates to improve standardization and accelerate study startup.
You can centrally manage site and investigator information along with milestone and status without the need for an in-house CTMS.
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.
Save time and reduce stress during inspections with an interface that’s intuitive and easy to train inspectors on.
Improve the clinical trial story you tell in inspections thanks to a dedicated inspector portal with robust access management and control.
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.
Nail down which documents you’ll need at each milestone and have the eTMF system do the heavy lifting for you.
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.
Strategically control access and permissions with granular detail, providing a clean and optimized interface for study stakeholders.
Dig into what might be contributing to quality issues in your eTMF system, finding and remediating them before an inspector does.
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.
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.
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.
Clinical sites can email essential documents directly into the system without a need for a user account.
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.
You can centrally manage site and investigator information and status without using a CTMS.
Export your TMF data to Excel for easy analysis, reporting, and sharing of the information that stakeholders need to see.
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.
Carefully control access across your study for external parties, providing the right information to the right sites at the right time.
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.
Stay consistently aligned with GCP and industry best practices thanks to an eTMF that’s built on them.
Pre-defined configuration is fully aligned with version 3.2. of the TMF Reference Model.
Ensure your records are compliant with 21 CFR Part 11 & Annex 11 compliant digital signatures.
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.
eTMF system features and functionalities designed to help you achieve end-to-end GDPR compliance with ease.
Avoid frustrations with logins, security, and network administration thanks to SSO and active directory integration.
Robust security, access management and configurable user roles let you share what needs to be shared and protect what needs to be protected.
Our QMS has been thoughtfully aligned to the ISO standards for quality management systems ensuring you remain compliant with requirements from the regulatory bodies.
See the Montrium eTMF in action in a live demo.
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.
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.
