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The Montrium Blog

The most helpful and thought-provoking ClinOps content from our writers on the front-lines of the life sciences industry

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The Top 22 Clinical Trial Conferences of 2023

Your Not-so-Secret Weapon for Inspection Readiness: TMF Health Checks

Asking for a Friend: How’s the Investigator Site File Different from the TMF?

The Proven Formula for Building an Expert-Approved TMF Process

The 4 electronic trial master file training topics ClinOps teams should master in 2023

Who else wants a healthy TMF? Nailing down your TMF QC strategy

What’s in the FDA draft guidance on Computer Software Assurance (CSA)?

The 4 must-have templates for managing TMF in house

No-frustration implementation: Why the pros use risk-based validation

GAMP® 5 Second Edition: What you should know

3 key ingredients for winning at Quality by Design in pharma

The ICH E6(R3) Battle Plan: Get your team ready

The ABCs of Data Integrity SOPs in the Pharmaceutical Industry

Top 10 benefits of a quality management system for life sciences

What’s in an acronym? ALCOA+ data integrity for the TMF

A reflection on the MHRA GCP Symposium: Trends that are transforming clinical trials

What is an FDA 483? Tips to dodge them in your next TMF audit

Find your why: The mission-driven note to file in clinical research

EU Regulation 536/2014: Everything You Need to Know, Simplified

Top 9 technology trends in the life sciences this year

Getting started with SOPs for CAPA in the pharmaceutical industry

The secret to managing change control in pharma like a pro

Outsourcing clinical trials: How to balance oversight and expectations

A guide to improved TMF metrics: the backbone of your TMF health

The Beginner's Guide to TMF Inspection Readiness

Debunking 3 common fears about eTMF implementation

The TMF Reference Model: The holy grail for better Sponsor-CRO relationships

A glance at the new EMA guidelines for computerised systems

Decentralized clinical trials: A growth lever for scaling life sciences organizations

Data-driven trial master file management: 8 experts share their best tips

Emerging Standards: A Path to leveraging AI & Machine Learning in TMF

2020 Wrapped: Montrium’s Best Webinars

A Complete Guide to TMF Reference Model 3.2 and What's New

10 Undeniable Benefits of eTMF Systems [Infographic]

How to Get Started With the TMF Reference Model [Infographic]

Is Our Obsession With AI in Clinical Trials Here to Stay?

Top Virtual Clinical Conferences 2020

Dear Sponsors, Avoid These TMF Outsourcing Danger Zones

15 Top Regulatory Conferences You Should Be Attending in 2020

20 Trial Master File Resolutions for 2020

A Clinical Christmas Carol

10 TED Talks Everyone in Pharma Should Watch in 2020 (+Bonus Talks)

Is eTMF Implementation Really That Scary?

Top 4 Predictions About the Future of eTMF

Putting the User First: How to Make Life Science Software More Effective

Is This the Biggest Trend in TMF Management This Year?

Why Service is the Most Important Part of Life Science SaaS

Clinical Research Associates (CRAs) Share Best Practices for Improving TMF Quality

Why You Should Select a Regulatory EDMS with RIM Functionality

Essential Regulatory Submission Metrics Your Team Should be Tracking

TMF Summit 2019 Round-Up

The Rise of eCTD: A Visual Explainer [Infographic]

QUIZ: How Much Do You Know About Regulatory Submissions?

Regulatory Submission Readiness in the Life Sciences and How Technology Can Help

eTMF Interoperability & Exchange: Finding Common Ground

How much do you know about TMF and clinical trials?

The Ultimate 'Who to Follow' Influencer List in the Life Sciences

30 LinkedIn Groups Every Pharma Professional Should Join

Do on-site TMF Inspections have a shelf life?

15 of the Most Valuable eTMF Software Features

10+ Questions you Should be Asking During an eTMF System Demonstration

Top 5 Clinical Trial Outsourcing Insights 2018 [Infographic]

TMF Strategy: 3 Ways to Get Your Finance Team on Board With an eTMF

Everything You Missed at the Inaugural TMF Institute in Boston

Blockchain: A Catalyst for Change in Clinical Trials

What Elements Should You Expect to See in Your eTMF?

Why Mock Inspections Should be Part of Your TMF Readiness Strategy

Asked and Answered: The TMF Migration Question

5 Ways an eTMF will Yield Powerful ROI for your Organization

6 Topics on the Top of Everyone's Mind at the 2018 TMF Summit

The 7 Characteristics of Highly Effective TMF Professionals [Infographic]

10 Items for Your eTMF Wish List this Holiday Season

3 Models for eTMF Centralization & Interchange

European TMF Summit Roundup: Key Takeaways from the 2017 Summit

The 5 W's of eTMF Planning

5 Reasons Why You Should be Attending DIA's Clinical & Regulatory Operational Excellence Forum

The State of Trial Master Files 2017 [Infographic]

How to Build a Killer Budget for an eTMF System

The Beginner's Guide to eTMF Completeness Reporting

How to Create a Business Case for eTMF That Your Board Can't Refuse

5 Key Areas of Consideration for Improving TMF Inspection Readiness [Infographic]

10 Benefits TMF Managers are Achieving with eTMF Systems

The Complete Feature Round-up of Montrium’s Regulatory Navigator

How to Successfully Prepare for the Upcoming FDA eCTD Deadlines

Top Articles You May Have Missed from the Montrium Blog in 2016

Leveraging Clinical Data: If it Already Happened, it's Not Analytics

Should Life Sciences Companies be worried about the Dropbox Password Hack?

Software Vendor Selection: Selecting the Winning Vendor

Software Vendor Selection: Requesting Proposals & Quotes

Software Vendor Selection: The Pitfalls and Successes of Vendor Demos

Software Vendor Selection: Finding the Right Vendor

Software Vendor Selection: How to Define Your Requirements

5 Essential Steps That Successful Companies Take During SaaS Software Onboarding

4 Ways the New eTMF Navigator Will Change How You Manage Clinical Trials

Prepare to be On-boarded: Prepping Your Internal Teams for New SaaS Software

5 Life Science Quality Conferences You’ll Want to Attend in 2020

10 FAQ’s About Trial Master Files (TMF) and Archiving….Answered

What is eTMF Software? And Does My Organization Need To Implement One?

Managing Trial Documents from Start to Finish in an eTMF Application

The State of Trial Master Files in 2015 [Infographic]

Don’t use an EDMS? Here are 4 Reasons Why It Might Be The Solution You Need!

Demystifying the Cloud: An Introduction into Cloud in a Digital World [Infographic]

How Software Gave Back to the World in 2015 [Infographic]

What to Expect from the 5th Annual TMF Summit in Arlington this Month

How to Write a Powerful Business Case for Implementing an EDMS

17 Questions to Ask in a Regulatory EDMS Software Demonstration

Electronic Trial Master Files (eTMF): What do the Regulatory Inspectors Really Expect?

Visit Montrium at Booth 2106 | DIA Annual Meeting in Washington

Meet Montrium: An Inside Look into our Company [Video]

A New eTMF Exchange Initiative: Presentation at the DIA eRegulatory and Intelligence Conference

5 Practical Steps to Assessing a SaaS Vendor for GxP Regulated Applications

Selecting the A-Team for your GxP System Implementation Project

Montrium Partners with B-EN-G Japan to Extend Reach into Life Sciences in Asia

The Beginner's Guide to Eudralex Vol. 4 Annex 11

6 Real-Life Struggles of Paper-Based Life Science Organizations

How to Reduce Time and Cost When Implementing an EDMS

5 Ways to Sell Electronic Document Management to a Skeptic

5 Tips and Tricks to Efficiently Sift Through Your Outlook Inbox After a Holiday Break

5 Questions Every Company Should Ask Before Selecting an EQMS

What is the TMF Reference Model?

9 Key Attributes of a Cloud-Based EDMS in the Life Sciences

The Beginners Guide to 21 CFR Part 11

21st Century Clinical Trials: A Brand New 3 Part Webinar Series

9 Must-Have IT SOP's When Implementing a Regulated Electronic System

Meet the Montrium Team: Kevin Chambers

15 Undeniable Reasons to Love SaaS in the Life Sciences

Spring/Summer Webinar Schedule Released - Life Sciences Sessions

Proprietary EDMS vs. SharePoint: Why Does SharePoint Come Out On Top?

10 Benefits of Moving to an Electronic Document Management System (EDMS)

10 More Essential Websites for Life Sciences Professionals

10 Essential Websites for Life Sciences Professionals