Upcoming Webinars

The Future of eTMF – Actionable Industry Trends & Insights

Tuesday, December 6th, 2018 at 11am EST

The way we manage the TMF is constantly evolving. Regulations are often catalysts to change in the eTMF space and staying on top of industry trends is vital in making sure you are working in the best possible way.

In our upcoming webinar, we will be exploring 5 of the hottest trends in the future of eTMF which include interoperability, traceability and data integrity, challenges of inspection when data is spread in multiple systems, and how the industry would be affected by the potential ratification of the TMF Reference Model by ICH.

We will also dive deeper into the inner workings of these trends and how we can begin to solve some of these issues which are spreading in the industry.

The webinar will cover the following topics:

  • Where the industry is today regarding eTMF
  • What regulatory bodies are initiating change in the clinical space
  • How the ICH is a catalyst to change in the TMF reference model
  • Traceability and data integrity in today’s model
  • Challenges of inspection with disparate systems
  • Interoperability and the future of eTMF
  • Plus much more…
Register Now

Previous Webinars

Outsourcing TMF Management: What are the CRO/Sponsor Responsibilities?

Thursday, August 28, 2018 at 11am EST

In our upcoming webinar, we will be exploring how dividing responsibilities between CRO and Sponsor in an outsourcing model can be leveraged to improve the quality of your trials. We’ll start by diving in to the world of outsourcing and what roles different organizations can play, and then explore some of the ways technology can enable outsourced TMF management to operate smoothly.

The webinar will cover the following topics:

  • Current state of the Sponsor responsibilities
  • Why have we begun to move to an outsourcing model?
  • What are some of the challenges this model presents?
  • What responsibilities lie with the Sponsor and with the CRO
  • How to best reap the benefits from an outsourcing model
  • How can leveraging technology makes this switch easier
  • Introduction to Montrium’s eTMF
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Integrating and Applying TMF Regulation into your Business Process

Tuesday, September 18, 2018 at 11am EST

Many organizations today still struggle to develop effective compliance strategies. In recent years we have seen a dramatic change in pace from regulatory authorities and standards organizations. With a wealth of new updates coming in, it is becoming increasingly more complex to remain compliant. With this in mind, our upcoming webinar will focus on the recent regulatory changes that will impact trial master files and provide a practical outlook on how to apply them and stay one step ahead.

The webinar will cover the following topics:

  • The changing regulatory landscape
  • How eTMF systems are shaping the regulations
  • Updates from the MHRA Symposium
  • Overview of the recent EMA guidance
  • Before and after the GCP E6 (R2) update
  • 21 CFR Part 11 for Trial Master File (recent update)
  • Practical considerations & applications for 2019 and beyond
  • The “State of the Union” of the TMF Landscape
  • And much more…
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Empowering Active TMF Management with an eTMF System

Tuesday, October 9th, 2018 at 11am EST

Active TMF Management is critical when conducting a trial. Managing your trial documentation on an on-going basis will allow organizations to have greater oversight on the completeness, empower team members to be timely, and ultimately be continuously inspection ready all while monitoring the quality of your documents.

In our upcoming webinar, we will be exploring how to use an eTMF System in its full capacity by empowering active TMF Management. We’ll start by understanding the measurable benefits gained by actively using an eTMF as opposed to using it solely as a repository.

We will also dive deeper into some of the features Montrium has developed as part of our eTMF which empowers clinical teams and gives organization’s the tool to have a successful study.

The webinar will cover the following topics:

•    What challenges are present when using an eTMF solely as a repository?
•    What it means to have active TMF Management with an eTMF System
•    How to empower clinical teams to collaborate and treat TMF as a living document
•   What tools an eTMF provides to allow for active management
•   What benefits active TMF management provides
•    Introduction to Montrium’s eTMF
•    Plus much more…

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Best Practices for Preparing for & Surviving TMF Inspections

Tuesday, November 8, 2018 at 11am EST

Inspections are the apex of the clinical trial. It is something that we prepare, plan for and ultimately dread for the entire duration of the study. Being inspection ready can take a significant burden off your clinical team, maximize time and get your product to market faster.
In our upcoming webinar, we will be exploring the best practices for preparing and surviving TMF inspections. We’ll start by diving into why inspection readiness should be continuous, and some key strategies to ensure your team has a successful inspection.
We will also dive deeper into some of the tools Montrium has developed that give your clinical teams an edge when it comes to surviving inspections, and providing your team greater oversight into eTMF completeness.

The webinar will cover the following topics:

•    Why is preparing for inspections important?
•    What are some of the challenges organizations face when it comes to inspections?
•    Why is it difficult to be inspection ready at all times?
•    Best practices when preparing for an upcoming inspection
•    How to survive the inspector
•    Introduction to Montrium’s eTMF
•    Plus much more…

Register Now

How to Build a Business Case for an eTMF

Tuesday, July 31st 2018 at 11am EST

In our upcoming webinar, we will be exploring the ways you can get internal buy-in and how to build out your business case. We will start by breaking down an eTMF business case and going through the sections you’ll need to include to have a successful meeting internally.

The webinar will cover the following topics:

  • Where is the industry today in relation to adopting eTMF?
  • Why is building a Business Case an important part of the process?
  • What to include in your Business Case
  • How to build a budget for an eTMF System
  • How to handle internal objections
  • Benefits of Implementing an eTMF including your ROI
  • Introduction to Montrium’s eTMF
Register Now

Attending an upcoming webinar?

Read Webinar FAQ

On-Demand Webinars

Frequently Asked Questions

Montrium Webinars

You are not required to call in or use a headset since you can hear the audio through your speakers. All attendees are muted automatically, so you won’t need a microphone. Otherwise, you can type your questions for the presenter, using your keyboard, as well as type chat messages.
No – we’ll take care of that for you. As an attendee, you are automatically muted.
The link to the login page should be sent to you in a confirmation email (from GotoMeeting) once you register for a webinar. On the day of the webinar, about 15 minutes before the webinar, you will be able to login to the webinar from this page and wait until the session begins. You will need to enter your name and email address that you registered with.

Audio for the webinar will be streamed via your computer speakers. Make sure that your computer speakers are on and test your system to see if you can receive audio via Macromedia Flash.

No. Presenters in the most part do not use the webcam or video feature during webinars. However, You will be viewing the computer screen of the presenter with slides or other content being shown.

Yes, unless the webinar is a live-only event (stated in event description) Montrium records all webinars and releases the video recording and slides on our website afterwards. Typically we send out an email to all registrants 2-3 business days after the webinar with a link to the video and slides.

Yes, we post all of our webinar presentation slide decks to our SlideShare account. You can find our profile at SlideShare.net/Hubspot as part of our follow-up, we also email all registrants with a link to the webinar recording and slides once they’re online.

If you haven’t received notifications from either the Montrium or GoToMeeting, please email marketing@montrium.com, at least two days in advance of the webinar. Please make sure you reference which webinar you are trying to attend.

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