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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.

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  • TMF
  • ClinOps

Building a Risk-based TMF Management Framework

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  • Validation

Our Cheat Code for 30-Day Adobe Acrobat Sign Validation

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  • Quality

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

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  • Inspection Readiness

Here’s How I Would Design the Perfect Mock Inspection

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  • Trial Master Files

The State of TMF Industry Report 2023

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  • Validation

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

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  • Trial Master Files

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

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  • Trial Master Files

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

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  • ClinOps
  • Trial Master Files

The Top 22 Clinical Trial Conferences of 2023

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  • Inspection Readiness
  • Trial Master Files

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

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  • Trial Master Files

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

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  • Trial Master Files

The Proven Formula for Building an Expert-Approved TMF Process

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  • ClinOps
  • Trial Master Files

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

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  • Trial Master Files

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

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  • Validation
  • Quality

What’s in the FDA draft guidance on Computer Software Assurance (CSA)?

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  • Trial Master Files

The 4 must-have templates for managing TMF in house

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  • Validation

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

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  • Regulations & Standards

GAMP® 5 Second Edition: What you should know

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  • Quality

3 key ingredients for winning at Quality by Design in pharma

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  • ClinOps
  • Regulations & Standards

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

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  • Quality

The ABCs of Data Integrity SOPs in the Pharmaceutical Industry

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  • Quality
  • Regulations & Standards

Top 10 benefits of a quality management system for life sciences

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  • Trial Master Files

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

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  • ClinOps

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

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  • Inspection Readiness
  • Trial Master Files

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

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  • Trial Master Files

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

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  • Regulations & Standards

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

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Top 9 technology trends in the life sciences this year

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  • Quality

Getting started with SOPs for CAPA in the pharmaceutical industry

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  • Quality

The secret to managing change control in pharma like a pro

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  • ClinOps
  • Trial Master Files

Outsourcing clinical trials: How to balance oversight and expectations

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  • Inspection Readiness
  • Trial Master Files

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

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  • Inspection Readiness
  • Trial Master Files

The Beginner's Guide to TMF Inspection Readiness

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  • Trial Master Files

Debunking 3 common fears about eTMF implementation

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  • Trial Master Files

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

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  • ClinOps
  • Regulations & Standards

A glance at the new EMA guidelines for computerised systems

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  • ClinOps

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

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  • Trial Master Files

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

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  • Trial Master Files

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

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  • ClinOps
  • Regulations & Standards
  • Trial Master Files

2020 Wrapped: Montrium’s Best Webinars

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  • Trial Master Files

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

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  • Quality
  • Inspection Readiness
  • Trial Master Files

10 Undeniable Benefits of eTMF Systems [Infographic]

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  • TMF Reference Model

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

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  • ClinOps
  • Trial Master Files

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

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  • ClinOps
  • Trial Master Files

Top Virtual Clinical Conferences 2020

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Dear Sponsors, Avoid These TMF Outsourcing Danger Zones

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  • RegOps

15 Top Regulatory Conferences You Should Be Attending in 2020

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  • Trial Master Files

20 Trial Master File Resolutions for 2020

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  • ClinOps
  • Trial Master Files

A Clinical Christmas Carol

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  • ClinOps

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

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  • Trial Master Files

Is eTMF Implementation Really That Scary?

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  • eTMF

Top 4 Predictions About the Future of eTMF

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  • Trial Master Files

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

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  • ClinOps
  • Trial Master Files

Is This the Biggest Trend in TMF Management This Year?

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  • Trial Master Files

Why Service is the Most Important Part of Life Science SaaS

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  • Quality
  • Trial Master Files

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

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  • RegOps
  • Regulations & Standards

Why You Should Select a Regulatory EDMS with RIM Functionality

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  • RegOps
  • Regulations & Standards

Essential Regulatory Submission Metrics Your Team Should be Tracking

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  • ClinOps
  • Trial Master Files

TMF Summit 2019 Round-Up

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  • RegOps
  • Regulations & Standards

The Rise of eCTD: A Visual Explainer [Infographic]

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  • RegOps
  • Regulations & Standards

QUIZ: How Much Do You Know About Regulatory Submissions?

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

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  • Regulations & Standards
  • Trial Master Files

eTMF Interoperability & Exchange: Finding Common Ground

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  • ClinOps
  • Trial Master Files

How much do you know about TMF and clinical trials?

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

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30 LinkedIn Groups Every Pharma Professional Should Join

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  • Inspection Readiness
  • Trial Master Files

Do on-site TMF Inspections have a shelf life?

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  • Trial Master Files

15 of the Most Valuable eTMF Software Features

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  • Trial Master Files

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

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  • ClinOps

Top 5 Clinical Trial Outsourcing Insights 2018 [Infographic]

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  • Trial Master Files

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

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  • Trial Master Files

Everything You Missed at the Inaugural TMF Institute in Boston

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  • ClinOps
  • Trial Master Files

Blockchain: A Catalyst for Change in Clinical Trials

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  • Inspection Readiness
  • Trial Master Files

What Elements Should You Expect to See in Your eTMF?

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  • Inspection Readiness
  • Trial Master Files

Why Mock Inspections Should be Part of Your TMF Readiness Strategy

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  • Quality
  • Inspection Readiness
  • Trial Master Files

Asked and Answered: The TMF Migration Question

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  • Trial Master Files

5 Ways an eTMF will Yield Powerful ROI for your Organization

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  • Inspection Readiness
  • Trial Master Files

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

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  • ClinOps
  • Trial Master Files

The 7 Characteristics of Highly Effective TMF Professionals [Infographic]

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  • Trial Master Files

10 Items for Your eTMF Wish List this Holiday Season

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  • Trial Master Files

3 Models for eTMF Centralization & Interchange

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  • Regulations & Standards
  • Inspection Readiness
  • Trial Master Files

European TMF Summit Roundup: Key Takeaways from the 2017 Summit

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  • Trial Master Files

The 5 W's of eTMF Planning

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  • RegOps
  • Regulations & Standards

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

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  • Trial Master Files

The State of Trial Master Files 2017 [Infographic]

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  • Trial Master Files

How to Build a Killer Budget for an eTMF System

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  • Inspection Readiness
  • Trial Master Files

The Beginner's Guide to eTMF Completeness Reporting

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  • ClinOps
  • Trial Master Files

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

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  • Inspection Readiness
  • Trial Master Files

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

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  • Quality
  • Inspection Readiness
  • Trial Master Files

10 Benefits TMF Managers are Achieving with eTMF Systems

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  • RegOps
  • Regulations & Standards

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

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  • RegOps
  • Regulations & Standards

How to Successfully Prepare for the Upcoming FDA eCTD Deadlines

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  • Validation
  • Quality
  • Trial Master Files

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

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  • ClinOps
  • Trial Master Files

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

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  • Quality

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

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  • RegOps

Software Vendor Selection: Selecting the Winning Vendor

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  • RegOps

Software Vendor Selection: Requesting Proposals & Quotes

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  • RegOps

Software Vendor Selection: The Pitfalls and Successes of Vendor Demos

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Software Vendor Selection: Finding the Right Vendor

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  • RegOps

Software Vendor Selection: How to Define Your Requirements

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  • Quality

5 Essential Steps That Successful Companies Take During SaaS Software Onboarding

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  • ClinOps
  • Trial Master Files

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

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  • Quality

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

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  • Quality

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

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  • Trial Master Files

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

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  • Trial Master Files

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

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  • ClinOps
  • Trial Master Files

Managing Trial Documents from Start to Finish in an eTMF Application

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  • Trial Master Files

The State of Trial Master Files in 2015 [Infographic]

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  • Quality

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

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  • Quality

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

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

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  • Trial Master Files

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

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  • RegOps

How to Write a Powerful Business Case for Implementing an EDMS

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  • RegOps

17 Questions to Ask in a Regulatory EDMS Software Demonstration

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  • Inspection Readiness
  • Trial Master Files

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

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  • Regulations & Standards

Visit Montrium at Booth 2106 | DIA Annual Meeting in Washington

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  • ClinOps
  • RegOps

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

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  • Regulations & Standards
  • Trial Master Files

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

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

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Selecting the A-Team for your GxP System Implementation Project

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

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  • Regulations & Standards

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

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  • Quality

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

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  • RegOps
  • Quality
  • Trial Master Files

How to Reduce Time and Cost When Implementing an EDMS

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5 Ways to Sell Electronic Document Management to a Skeptic

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

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  • Quality

5 Questions Every Company Should Ask Before Selecting an EQMS

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  • Regulations & Standards
  • Trial Master Files

What is the TMF Reference Model?

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  • RegOps

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

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  • Regulations & Standards

The Beginners Guide to 21 CFR Part 11

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  • ClinOps

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

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  • Regulations & Standards

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

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Meet the Montrium Team: Kevin Chambers

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15 Undeniable Reasons to Love SaaS in the Life Sciences

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Spring/Summer Webinar Schedule Released - Life Sciences Sessions

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  • RegOps

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

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  • RegOps

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

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10 More Essential Websites for Life Sciences Professionals

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10 Essential Websites for Life Sciences Professionals

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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. ...

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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 ...

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