<img height="1" width="1" style="display:none" src="https://www.facebook.com/tr?id=377593866636424&amp;ev=PageView&amp;noscript=1">
Montrium_Logo_smaller
←
Book a demo Get in touch
Close

Book a live demo

Schedule a demo with a representative.
Close

Reach out to our team

The Montrium blog

Your one-stop-shop for the most helpful and up-to-date ClinOps content written by our experts on the front lines of the life sciences industry.

  • all ()
  • TMF
  • ClinOps
  • Validation
  • Quality
  • Inspection Readiness
  • Trial Master Files
  • Validation
  • Trial Master Files
  • Trial Master Files
  • ClinOps
  • Trial Master Files
  • Inspection Readiness
  • Trial Master Files
  • Trial Master Files
  • Trial Master Files
  • ClinOps
  • Trial Master Files
  • Trial Master Files
  • Validation
  • Quality
  • Trial Master Files
  • Validation
  • Regulations & Standards
  • Quality
  • ClinOps
  • Regulations & Standards
  • Quality
  • Quality
  • Regulations & Standards
  • Trial Master Files
  • ClinOps
  • Inspection Readiness
  • Trial Master Files
  • Trial Master Files
  • Regulations & Standards
  • Quality
  • Quality
  • ClinOps
  • Trial Master Files
  • Inspection Readiness
  • Trial Master Files
  • Inspection Readiness
  • Trial Master Files
  • Trial Master Files
  • Trial Master Files
  • ClinOps
  • Regulations & Standards
  • ClinOps
  • Trial Master Files
  • Trial Master Files
  • ClinOps
  • Regulations & Standards
  • Trial Master Files
  • Trial Master Files
  • ClinOps
  • Trial Master Files
  • ClinOps
  • Trial Master Files
  • RegOps
  • Trial Master Files
  • ClinOps
  • Trial Master Files
  • ClinOps
  • Trial Master Files
  • eTMF
  • Trial Master Files
  • ClinOps
  • Trial Master Files
  • Trial Master Files
  • Quality
  • Trial Master Files
  • RegOps
  • Regulations & Standards
  • RegOps
  • Regulations & Standards
  • ClinOps
  • Trial Master Files
  • RegOps
  • Regulations & Standards
  • Regulations & Standards
  • Trial Master Files
  • ClinOps
  • Trial Master Files
  • Inspection Readiness
  • Trial Master Files
  • Trial Master Files
  • Trial Master Files
  • Trial Master Files
  • Trial Master Files
  • ClinOps
  • Trial Master Files
  • Inspection Readiness
  • Trial Master Files
  • Inspection Readiness
  • Trial Master Files
  • Quality
  • Inspection Readiness
  • Trial Master Files
  • Trial Master Files
  • Inspection Readiness
  • Trial Master Files
  • Trial Master Files
  • Trial Master Files
  • Regulations & Standards
  • Inspection Readiness
  • Trial Master Files
  • Trial Master Files
  • RegOps
  • Regulations & Standards
  • Trial Master Files
  • Inspection Readiness
  • Trial Master Files
  • ClinOps
  • Trial Master Files
  • Quality
  • Inspection Readiness
  • Trial Master Files
  • RegOps
  • Regulations & Standards
  • RegOps
  • Regulations & Standards
  • Validation
  • Quality
  • Trial Master Files
  • ClinOps
  • Trial Master Files
  • Quality
  • RegOps
  • RegOps
  • RegOps
  • RegOps
  • Quality
  • ClinOps
  • Trial Master Files
  • Quality
  • Quality
  • Trial Master Files
  • Trial Master Files
  • ClinOps
  • Trial Master Files
  • Quality
  • Trial Master Files
  • RegOps
  • RegOps
  • Inspection Readiness
  • Trial Master Files
  • Regulations & Standards
  • ClinOps
  • RegOps
  • Regulations & Standards
  • Trial Master Files
  • Regulations & Standards
  • Quality
  • RegOps
  • Quality
  • Trial Master Files
  • Quality
  • Regulations & Standards
  • Trial Master Files
  • RegOps
  • Regulations & Standards
  • ClinOps
  • Regulations & Standards
  • RegOps
  • RegOps

X

  • TMF
  • ClinOps

Building a Risk-based TMF Management Framework

Read It
  • Validation

Our Cheat Code for 30-Day Adobe Acrobat Sign Validation

Read It
  • Quality

Essential eQMS Buyer's Guide for Life Science Organizations in 2024

Read It
  • Inspection Readiness

Here’s How I Would Design the Perfect Mock Inspection

Read It
  • Trial Master Files

The State of TMF Industry Report 2023

Read It
  • Validation

The Roadmap to Validating Adobe Acrobat Sign for 21 CFR Part 11

Read It
  • Trial Master Files

From Archivists to Strategists: The New Role of the TMF Manager

Read It
  • Trial Master Files

Active vs Passive TMF Management: Take Your TMF Process to the Next Level

Read It
  • ClinOps
  • Trial Master Files

The Top 22 Clinical Trial Conferences of 2023

Read It
  • Inspection Readiness
  • Trial Master Files

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

Read It
  • Trial Master Files

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

Read It
  • Trial Master Files

The Proven Formula for Building an Expert-Approved TMF Process

Read It
  • ClinOps
  • Trial Master Files

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

Read It
  • Trial Master Files

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

Read It
  • Validation
  • Quality

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

Read It
  • Trial Master Files

The 4 must-have templates for managing TMF in house

Read It
  • Validation

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

Read It
  • Regulations & Standards

GAMP® 5 Second Edition: What you should know

Read It
  • Quality

3 key ingredients for winning at Quality by Design in pharma

Read It
  • ClinOps
  • Regulations & Standards

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

Read It
  • Quality

The ABCs of Data Integrity SOPs in the Pharmaceutical Industry

Read It
  • Quality
  • Regulations & Standards

Top 10 benefits of a quality management system for life sciences

Read It
  • Trial Master Files

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

Read It
  • ClinOps

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

Read It
  • Inspection Readiness
  • Trial Master Files

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

Read It
  • Trial Master Files

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

Read It
  • Regulations & Standards

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

Read It

Top 9 technology trends in the life sciences this year

Read It
  • Quality

Getting started with SOPs for CAPA in the pharmaceutical industry

Read It
  • Quality

The secret to managing change control in pharma like a pro

Read It
  • ClinOps
  • Trial Master Files

Outsourcing clinical trials: How to balance oversight and expectations

Read It
  • Inspection Readiness
  • Trial Master Files

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

Read It
  • Inspection Readiness
  • Trial Master Files

The Beginner's Guide to TMF Inspection Readiness

Read It
  • Trial Master Files

Debunking 3 common fears about eTMF implementation

Read It
  • Trial Master Files

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

Read It
  • ClinOps
  • Regulations & Standards

A glance at the new EMA guidelines for computerised systems

Read It
  • ClinOps

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

Read It
  • Trial Master Files

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

Read It
  • Trial Master Files

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

Read It
  • ClinOps
  • Regulations & Standards
  • Trial Master Files

2020 Wrapped: Montrium’s Best Webinars

Read It
  • Trial Master Files

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

Read It
  • ClinOps
  • Trial Master Files

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

Read It
  • ClinOps
  • Trial Master Files

Top Virtual Clinical Conferences 2020

Read It

Dear Sponsors, Avoid These TMF Outsourcing Danger Zones

Read It
  • RegOps

15 Top Regulatory Conferences You Should Be Attending in 2020

Read It
  • Trial Master Files

20 Trial Master File Resolutions for 2020

Read It
  • ClinOps
  • Trial Master Files

A Clinical Christmas Carol

Read It
  • ClinOps

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

Read It
  • Trial Master Files

Is eTMF Implementation Really That Scary?

Read It
  • eTMF

Top 4 Predictions About the Future of eTMF

Read It
  • Trial Master Files

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

Read It
  • ClinOps
  • Trial Master Files

Is This the Biggest Trend in TMF Management This Year?

Read It
  • Trial Master Files

Why Service is the Most Important Part of Life Science SaaS

Read It
  • Quality
  • Trial Master Files

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

Read It
  • RegOps
  • Regulations & Standards

Why You Should Select a Regulatory EDMS with RIM Functionality

Read It
  • RegOps
  • Regulations & Standards

Essential Regulatory Submission Metrics Your Team Should be Tracking

Read It
  • ClinOps
  • Trial Master Files

TMF Summit 2019 Round-Up

Read It
  • RegOps
  • Regulations & Standards

QUIZ: How Much Do You Know About Regulatory Submissions?

Read It

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

Read It
  • Regulations & Standards
  • Trial Master Files

eTMF Interoperability & Exchange: Finding Common Ground

Read It
  • ClinOps
  • Trial Master Files

How much do you know about TMF and clinical trials?

Read It

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

Read It

30 LinkedIn Groups Every Pharma Professional Should Join

Read It
  • Inspection Readiness
  • Trial Master Files

Do on-site TMF Inspections have a shelf life?

Read It
  • Trial Master Files

15 of the Most Valuable eTMF Software Features

Read It
  • Trial Master Files

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

Read It
  • Trial Master Files

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

Read It
  • Trial Master Files

Everything You Missed at the Inaugural TMF Institute in Boston

Read It
  • ClinOps
  • Trial Master Files

Blockchain: A Catalyst for Change in Clinical Trials

Read It
  • Inspection Readiness
  • Trial Master Files

What Elements Should You Expect to See in Your eTMF?

Read It
  • Inspection Readiness
  • Trial Master Files

Why Mock Inspections Should be Part of Your TMF Readiness Strategy

Read It
  • Quality
  • Inspection Readiness
  • Trial Master Files

Asked and Answered: The TMF Migration Question

Read It
  • Trial Master Files

5 Ways an eTMF will Yield Powerful ROI for your Organization

Read It
  • Inspection Readiness
  • Trial Master Files

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

Read It
  • Trial Master Files

10 Items for Your eTMF Wish List this Holiday Season

Read It
  • Trial Master Files

3 Models for eTMF Centralization & Interchange

Read It
  • Regulations & Standards
  • Inspection Readiness
  • Trial Master Files

European TMF Summit Roundup: Key Takeaways from the 2017 Summit

Read It
  • Trial Master Files

The 5 W's of eTMF Planning

Read It
  • RegOps
  • Regulations & Standards

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

Read It
  • Trial Master Files

How to Build a Killer Budget for an eTMF System

Read It
  • Inspection Readiness
  • Trial Master Files

The Beginner's Guide to eTMF Completeness Reporting

Read It
  • ClinOps
  • Trial Master Files

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

Read It
  • Quality
  • Inspection Readiness
  • Trial Master Files

10 Benefits TMF Managers are Achieving with eTMF Systems

Read It
  • RegOps
  • Regulations & Standards

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

Read It
  • RegOps
  • Regulations & Standards

How to Successfully Prepare for the Upcoming FDA eCTD Deadlines

Read It
  • Validation
  • Quality
  • Trial Master Files

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

Read It
  • ClinOps
  • Trial Master Files

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

Read It
  • Quality

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

Read It
  • RegOps

Software Vendor Selection: Selecting the Winning Vendor

Read It
  • RegOps

Software Vendor Selection: Requesting Proposals & Quotes

Read It
  • RegOps

Software Vendor Selection: The Pitfalls and Successes of Vendor Demos

Read It

Software Vendor Selection: Finding the Right Vendor

Read It
  • RegOps

Software Vendor Selection: How to Define Your Requirements

Read It
  • Quality

5 Essential Steps That Successful Companies Take During SaaS Software Onboarding

Read It
  • ClinOps
  • Trial Master Files

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

Read It
  • Quality

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

Read It
  • Quality

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

Read It
  • Trial Master Files

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

Read It
  • Trial Master Files

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

Read It
  • ClinOps
  • Trial Master Files

Managing Trial Documents from Start to Finish in an eTMF Application

Read It
  • Quality

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

Read It
  • Trial Master Files

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

Read It
  • RegOps

How to Write a Powerful Business Case for Implementing an EDMS

Read It
  • RegOps

17 Questions to Ask in a Regulatory EDMS Software Demonstration

Read It
  • Inspection Readiness
  • Trial Master Files

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

Read It
  • Regulations & Standards

Visit Montrium at Booth 2106 | DIA Annual Meeting in Washington

Read It
  • ClinOps
  • RegOps

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

Read It
  • Regulations & Standards
  • Trial Master Files

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

Read It

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

Read It

Selecting the A-Team for your GxP System Implementation Project

Read It

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

Read It
  • Regulations & Standards

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

Read It
  • Quality

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

Read It
  • RegOps
  • Quality
  • Trial Master Files

How to Reduce Time and Cost When Implementing an EDMS

Read It

5 Ways to Sell Electronic Document Management to a Skeptic

Read It

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

Read It
  • Quality

5 Questions Every Company Should Ask Before Selecting an EQMS

Read It
  • Regulations & Standards
  • Trial Master Files

What is the TMF Reference Model?

Read It
  • RegOps

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

Read It
  • Regulations & Standards

The Beginners Guide to 21 CFR Part 11

Read It
  • ClinOps

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

Read It
  • Regulations & Standards

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

Read It

Meet the Montrium Team: Kevin Chambers

Read It

15 Undeniable Reasons to Love SaaS in the Life Sciences

Read It

Spring/Summer Webinar Schedule Released - Life Sciences Sessions

Read It
  • RegOps

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

Read It
  • RegOps

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

Read It

10 More Essential Websites for Life Sciences Professionals

Read It

10 Essential Websites for Life Sciences Professionals

Read It
subscribe-top

Get our best content delivered straight to your inbox
hading-icon

Editors pick

Active vs Passive TMF Management: Take Your TMF Process to the Next Level

History is full of tales about how technological and process innovations have shaped society for the better. Take the printing press, for example. ...

Read more

The Top 22 Clinical Trial Conferences of 2023

As the clinical trials market continues to grow, so do industry events. Whether it’s to meet your next big client, form your next partnership, grow ...

Read more
The State of TMF

Live Event & Podcast

The biggest podcast for TMF'ers on the planet

Through interviews, AMA's, and invite-only events, we give you a sneak peek into the data-backed insights we are executing for TMF teams across the globe.

Join the live event