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Montrium

Name: Montrium
Address: Montreal, QC, CA
Telephone: +15142239153

Powering R&D at emerging sponsors and CROs🔬

We focus on improving the management and tracking of GxP related activities and documentation through our solutions and related services.

01/31/2025

Let’s make a deal:

No more all-nighters for re-filing misfiled artifacts. 🤝

Let’s make things easier for our TMF teams (and ourselves) by seeing how we can start aligning our artifact types to those in the CDISC TMF Reference Model.

The TMF RM isn’t as rigid as you’d think—99% of the time, you can map your document type to one of those listed in it.

As the industry continues to adopt the TMF Reference Model, it will become even easier to present TMF content to inspectors, and to share TMF content between clinical trial stakeholders.

Not only will aligning with the TMF RM save you time and resources; it will also get you out of sleep debt.

What’s your experience with the TMF RM?

01/28/2025

The quality buffs out there will get it:

It’s easy to go off the rails with change controls.

But we’ve got you covered.

Keep your peace of mind and steal our change control process cheat sheet. 👇

01/24/2025

Complicated quality processes often lead to 2 key issues:

❌ Underreporting

❌ Confusion

Dawn shares how to keep it simple and what you should be looking for in a root cause analysis. 👇

01/23/2025

Stop underestimating your TMF.

We know, it’s easy to get in the habit of filing away documents until it’s inspection time.

But the TMF is more than meets the eye.

And it deserves to have proper processes in place to deal with the fundamental documents within it.

Which processes does your organization have in place to help manage the TMF? Let’s chat below!

01/21/2025

Assessed a vendor to be medium or high-risk?

It’s time for an audit.

Here’s a quick guide to help you develop your own internal audit program—from creating the plan to beginning the follow-up process after the report is written.

01/16/2025

How much should you scrutinize vendors before signing a contract?

The answer:

It depends.

Maria discusses factors you should consider:

01/14/2025

Vendor risk assessments don’t have to be complicated.

In fact, the best way to conduct vendor risk assessments is to be as pragmatic as possible.

Don’t get bogged down by creating unnecessary categories and complex scoring conventions. Steal this vendor risk assessment template developed by Maria Veleva of Velev Consulting.

01/03/2025

What’s your quality system going to look like?

When fleshing this out, it’s vital to remember these 3 components.

🗂️ Structure: How do you want to organize your policies and procedures? What is your hierarchy?

👩‍💻 Key roles: Who will be performing the tasks and actions? How will you identify the roles (job title or generic role)?

📝 SOPs: What will your SOP structure look like? Think: naming and numbering conventions, templates for each document type, and formatting requirements.

What’s your experience with building quality systems? Did we miss anything? Let’s chat below!

12/30/2024

There are A LOT of moving parts in a quality system.

Having a holistic, bird’s eye view of the system will enable you to promote proactive, data-driven decision making and better support your organization’s quality culture.

Here’s what that single source of truth should look like:

12/23/2024

It’s that time of year… 😅

12/19/2024

To all the biopharmas getting started on your quality journey, you’ll want to read this.

Do you ever find yourself wondering:

“How am I going to develop the key processes that will give structure to my organization?”

If you said “yes,” the best place to begin is with process lists.

We’re sharing our cheat sheet on process lists to help you get started.

12/18/2024

Has the CDISC TMF Reference Model made TMF management more complicated?

In episode 2 of the State of TMF podcast, Karen Roy responds to some of your feedback about the TMF RM.

What are your thoughts on the CDISC TMF Reference Model? Let us know in the comments!

Address

Montreal, QC

Opening Hours

Monday	8am - 6pm
Tuesday	8am - 6pm
Wednesday	8am - 6pm
Thursday	8am - 6pm
Friday	8am - 6pm

Telephone

+15142239153

Website

http://www.montrium.com/

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