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Montrium
Canada
Registrace 3. 04. 2012
Montrium provides electronic document management technology for clinical, quality, and regulatory teams and GxP services to the life sciences industry. Visit www.montrium.com for more info.
The State of TMF - S2 E9 - More than an Archive - Moving to an Active TMF Management Model
Managing your TMF program effectively with outdated or inefficient processes can feel overwhelming, especially with limited resources and an evolving regulatory environment. Today, teams are transitioning away from passive TMF models that prioritize an archivist mindset towards a more modern and agile approach to TMF focused on managing and compiling the TMF in an active manner.
In this session, Donatella Ballerini and Oliver Pearce of Montrium will guide you through the essential components of active TMF management. They will introduce Montrium's TMF Maturity Model, providing a structured approach to evaluate and advance your TMF processes. You'll learn how to leverage technology for real-time oversight and ensure your TMF team maintains an agile TMF mindset.
CHAPTERS
00:00 Intros (Hosts and Topic)
03:17 The meaning of Agile TMF
05:15 Moving from a Traditional TMF mindset to Agile TMF
07:25 Key principles of an Agile TMF
14:30 How to implement adaptive metrics and which ones to focus on in an Agile TMF
17:36 Examples of of an Agile TMF Process
20:55 How often should you review/measure your metrics
22:40 Improving timeliness n=metrics using an Agile TMF
24:45 Applying an agile approach in your current TMF process
28:22 Data Driven Approach in an Agile TMF
30:22 Essential tools needed to move to an Agile TMF Approach
34:20 The Environment after implementing an Agile TMF Approach in an organization
38:05 How to transition from a passive to an active approach when dealing with different studies
39:56 Challenges an organization may face when moving to an Agile TMF approach
41:39 Wrap up
42:07 Outro Season 2
---------------------------------------------------------
Subscribe to The State of TMF Live Events: hubs.ly/Q01Hy0NW0
Join our community: hubs.ly/Q027nggP0
Join us on Instagram: montrium
Join us on Facebook: Montrium/
In this session, Donatella Ballerini and Oliver Pearce of Montrium will guide you through the essential components of active TMF management. They will introduce Montrium's TMF Maturity Model, providing a structured approach to evaluate and advance your TMF processes. You'll learn how to leverage technology for real-time oversight and ensure your TMF team maintains an agile TMF mindset.
CHAPTERS
00:00 Intros (Hosts and Topic)
03:17 The meaning of Agile TMF
05:15 Moving from a Traditional TMF mindset to Agile TMF
07:25 Key principles of an Agile TMF
14:30 How to implement adaptive metrics and which ones to focus on in an Agile TMF
17:36 Examples of of an Agile TMF Process
20:55 How often should you review/measure your metrics
22:40 Improving timeliness n=metrics using an Agile TMF
24:45 Applying an agile approach in your current TMF process
28:22 Data Driven Approach in an Agile TMF
30:22 Essential tools needed to move to an Agile TMF Approach
34:20 The Environment after implementing an Agile TMF Approach in an organization
38:05 How to transition from a passive to an active approach when dealing with different studies
39:56 Challenges an organization may face when moving to an Agile TMF approach
41:39 Wrap up
42:07 Outro Season 2
---------------------------------------------------------
Subscribe to The State of TMF Live Events: hubs.ly/Q01Hy0NW0
Join our community: hubs.ly/Q027nggP0
Join us on Instagram: montrium
Join us on Facebook: Montrium/
zhlédnutí: 79
Video
The State of TMF - S2 E8 - Battle of the Binders: What's the Difference Between the TMF & the ISF?
zhlédnutí 147Před 3 měsíci
Distinguishing between the ISF and the TMF is an all-too-frequent source of confusion in clinical documentation. Are they the same? Are they different? The answer to both of those questions is yes. Join special guests Aryn Knight and Matt Lowery as they get into the nitty gritty of the great ISF-TMF debate. We'll be covering which contents are specific to the ISF vs which are specific to the TM...
The State of TMF - S2 E7: The TMF'ers Guide to Audit Trail Reviews
zhlédnutí 171Před 4 měsíci
Audit trail reviews may be a hot topic in the world of TMF right now, but that doesn't mean people know how to do them the right way. In this episode of The State of TMF, our experts will explain everything you need to know about audit trail reviews. We'll be going over the basics of audit trail reviews, the "why" and "how" of routine ATRs, which high-risk data points you should be reviewing, a...
The State of TMF - S2 E6: How to Build an Adaptive TMF Index for Any Study
zhlédnutí 110Před 5 měsíci
It's important to have standards-especially when it comes to the TMF index. Aligning your TMF index to the CDISC TMF Reference Model makes it easy for organizations to speak the same language, helps you breeze through M&As, and streamlines system migrations. In this episode of the State of TMF, our host Oliver Pearce will be joined by guest Anne Ackley-Fifer from Daelight Solutions. They'll dis...
The State of TMF - S2 E5: Building Champions & Getting Non-TMF’ers engaged
zhlédnutí 114Před 6 měsíci
If the TMF is the cornerstone of a clinical trial, then why do so many TMFers find themselves having to convince others of its importance? The answer: culture. In this episode, we crack the TMF culture code and explain how you can get stakeholder buy-in, keep non-TMFers engaged, and ensure that everyone is doing their part. Our experts will discuss tips for training, ways to gamify TMF manageme...
The State of TMF - S2 E4: Crafting a TMF Training Program for your team
zhlédnutí 130Před 7 měsíci
We kicked off 2024 with our most popular State of TMF episode yet! Loads of you turned up to last week to learn more about TMF training-and how to do it right. Not only did our hosts share their foolproof 5-step formula for crafting an effective TMF training program for your team, but they also got real about some of the training struggles they've faced throughout their careers. If you or your ...
The State of TMF - S2 E3: Risk-Based TMF Management 101
zhlédnutí 148Před 8 měsíci
Risk-based TMF management is set to be all the rage in 2024, and we want to help you hit the ground running. On the latest episode of The State of TMF, our experts shared their innovative and unique approach to risk-based TMF. They were also be joined by InSeption Group's EVP of QA & Compliance, Dawn Niccum, to discuss the past, present and what all TMF'ers need to know about the imminent futur...
The State of TMF - S2 E2: Trackers & Logs in the TMF: Where to file them?
zhlédnutí 119Před 8 měsíci
Trackers and logs are a notorious source of confusion in the TMF. But fear not, because our experts joined forces to discuss exactly where you should be filing trackers and logs in your TMF. They also shared a real (scary) story about what happens when an inspector asks to see a log that wasn't maintained 😱 and how you can avoid this happening to you. CHAPTERS: 00:00 Intro 01:58 Topic intro 02:...
TMF Week 2021 - Day 5 - 1230PM - PANEL: What does the next generation eTMF system look like?
zhlédnutí 26Před 8 měsíci
NextGen eTMF is on the horizon and it promises to be very different! We will discuss key areas on NextGen during this panel including: Data vs documents, Artifact relationships, clustering and telling a better story, More intelligent and accurate metrics, Remote and continuous inspections, Interchange, and standardization.
TMF Week 2021 - Day 5 - 11AM: How Technology has Evolved to meet the Clinical Trials of today
zhlédnutí 9Před 8 měsíci
Today’s common practice of using disparate systems has resulted in inconsistencies, data discrepancies, and duplicative efforts. As the clinical trial industry continues to generate massive amounts of data, the need for efficient data collection and integration has increased for the eTMF system and other eClinical systems.
TMF Week 2021 - Day 5 - 10AM: Using Integrated Systems for a more Holistic Approach
zhlédnutí 12Před 8 měsíci
You cannot tell a true TMF story without looking at the different systems, quality events, data and processes that exist in our technology and clinical ecosystems. Using connected systems and taking an integrated approach to your planning and management can help you plan and manage your TMF in a more holistic way. In this session we'll be covering: Interconnected process-based systems, How to b...
TMF Week 2021 - Day 4 - 1230PM - PANEL: Updates to ICH GCP - How Quality by Design impacts the TMF
zhlédnutí 29Před 8 měsíci
With the anticipated updates to ICH E6(R3), Quality by Design and Risk Management will be raised to the forefront in Clinical Trials. How will this impact the population and management of the TMF? What TMF practices already point to Quality by Design? How will the use of metrics drive the focus of the quality of the TMF? How are you “designing” your TMF to drive quality? Attend this panel to fi...
TMF Week 2021 - Day 5 - 9AM - Implementing an eTMF at a Scaling CRO: Steps for Success
zhlédnutí 13Před 8 měsíci
The benefits of switching to an eTMF from a paper system are widespread and well-recognized and in order to reap those benefits, an implementation process is inevitable. There are many factors that can help complete the implementation process in a stream-lined and timely manner. In this session, we will take a deep dive into a case study on the implementation of eTMF Connect at Allphase, a Cana...
TMF Week 2021 - Day 4 -11AM: Standardization of eTMF Drawing parallels in Industry
zhlédnutí 20Před 8 měsíci
Data and document standards have existed for some time within the clinical trials arena and are considered essential for the identification, management, and exchange of clinical trial information between stakeholders and systems. These standards cover everything from clinical data collection to regulatory submissions. TMF is the final frontier when it comes to standardization, and standardizati...
TMF Week 2021 - Day 4 - 10AM: Standardising Document Management Approaches to Real-World Studies
zhlédnutí 21Před 8 měsíci
Discover the "pain points" of Real-World Studies vs GCP Clinical Trials as well as understanding how the RWS climate is changing and impacting on study design and conduct. We will also cover how Real-World Study Master Files are created as well as the good document practices that should be observed during real-world studies.
TMF Week 2021 - Day 3 - 1230PM: PANEL: Data Driven Deliverables - the D3 of Sponsor Oversight
zhlédnutí 20Před 8 měsíci
TMF Week 2021 - Day 3 - 1230PM: PANEL: Data Driven Deliverables - the D3 of Sponsor Oversight
TMF Week 2021 - Day 4 - 9AM: How to Avoid Last Minute Inspection Chaos Periodic Review of the TMF
zhlédnutí 53Před 8 měsíci
TMF Week 2021 - Day 4 - 9AM: How to Avoid Last Minute Inspection Chaos Periodic Review of the TMF
TMF Week 2021 - Day 3 - 9AM: The Many Changing Faces of Sponsor Oversight and How the TMF Fits in!
zhlédnutí 33Před 8 měsíci
TMF Week 2021 - Day 3 - 9AM: The Many Changing Faces of Sponsor Oversight and How the TMF Fits in!
TMF Week 2021 - Day 3 - 11AM: TMF Oversight within a Multi Vendor TMF Ecosystem
zhlédnutí 20Před 8 měsíci
TMF Week 2021 - Day 3 - 11AM: TMF Oversight within a Multi Vendor TMF Ecosystem
TMF Week 2021 - Day 3 - 10AM: Trial Master Files TMFs through the eyes of a Clinical Study Associate
zhlédnutí 45Před 8 měsíci
TMF Week 2021 - Day 3 - 10AM: Trial Master Files TMFs through the eyes of a Clinical Study Associate
TMF Week 2021 - Day 2 - 1230PM PANEL: The Universe of Start up Records How do we make it easier?
zhlédnutí 23Před 8 měsíci
TMF Week 2021 - Day 2 - 1230PM PANEL: The Universe of Start up Records How do we make it easier?
TMF Week 2021 - Day 2 - 10AM: The Foundation of the Clinical Trial Story starts with Study Startup
zhlédnutí 27Před 8 měsíci
TMF Week 2021 - Day 2 - 10AM: The Foundation of the Clinical Trial Story starts with Study Startup
TMF Week 2021 - Day 2 - 9AM: Bridging the ISF TMF Divide: The Roles of Sponsors & Investigators.
zhlédnutí 24Před 8 měsíci
TMF Week 2021 - Day 2 - 9AM: Bridging the ISF TMF Divide: The Roles of Sponsors & Investigators.
TMF Week 2021 - Day 1 - 1230PM: PANEL: How does TMF Health impact study quality?
zhlédnutí 31Před 8 měsíci
TMF Week 2021 - Day 1 - 1230PM: PANEL: How does TMF Health impact study quality?
TMF Week 2021 - Day 1 - 11AM: The Benefits of AI in eTMF How to Better Your Overall eTMF health
zhlédnutí 50Před 8 měsíci
TMF Week 2021 - Day 1 - 11AM: The Benefits of AI in eTMF How to Better Your Overall eTMF health
TMF Week 2021 - Day 1 - 9AM - Opening Keynote: Decentralized Clinical Trials & its impact on the TMF
zhlédnutí 40Před 8 měsíci
TMF Week 2021 - Day 1 - 9AM - Opening Keynote: Decentralized Clinical Trials & its impact on the TMF
TMF Maturity Day - Session 4: Developing a Trial Master File Metrics Roadmap
zhlédnutí 41Před 8 měsíci
TMF Maturity Day - Session 4: Developing a Trial Master File Metrics Roadmap
TMF Maturity Day - Session 3: Trial Master File AMA: Ask our experts any question
zhlédnutí 2Před 8 měsíci
TMF Maturity Day - Session 3: Trial Master File AMA: Ask our experts any question
TMF Maturity Day - Session 2: Building a TMF Management Process from Start to Finish
zhlédnutí 24Před 8 měsíci
TMF Maturity Day - Session 2: Building a TMF Management Process from Start to Finish
TMF Maturity Day - Session 1: How to Identify Your Organization's TMF Maturity & Planning for Growth
zhlédnutí 11Před 8 měsíci
TMF Maturity Day - Session 1: How to Identify Your Organization's TMF Maturity & Planning for Growth
I adore this marvelous video discussing decentralized clinical trials and their impact on TMF. What specific insights or advancements does the video highlight regarding the integration of decentralized approaches in clinical trial management? I love this video! I’ve liked and subscribed.
🌈 "PromoSM"
Nice explanation, thank you
That's an AI
"Contemporaneous" wow normally "Testing Schedule" :) but nicely spoken and informative
Very nice explanation. Thank You So Much.
Can we have a PDF doc for reference?
Very informative
we are interested
Gud info
excellent sessions
Can you share me this presentation, on my email- nileshkhule20@yahoo.com
thanks........
nice one i can use ur webinar as an example as i am going for a job interview for the IT aspect of LIMS.
@24:52 "Electronically 17% , Paper 42% , Hybrid Approach 42%" 🤔 ........Total = 101% ----> Software Validated !!!!! 🤣🤣🤣. Nonethles still remain a very useful presentation. Thanks 🤗
GOOD TO SEE #PHARMACEUTICALCONCEPT
For those new to computer system validation or just looking for refreshers there are several free webinars given by Praxis life sciences. If you go to validationcenter.com you can sign up for the free webinars (they also have paid classes but I can’t comment on those). The speaker Deb Bartel does a wonderful job of presenting naturally and with humor and the “slides“ are well constructed for making that connection to her spoken word. Btw i’m not affiliated with this company in any way just an individual who has enjoyed the webinars.
A lot of information on the basics of computer system validation are provided however it sounds entirely scripted. It is not being presented naturally like many WebEx allowing the audience to feel engaged. it just sounds like she’s reading off a script and rushing through it. So while informative I’ve had to stop and replay often to grasp what is said in order to comprehend it. And I am an experienced senior CSV consultant Who already knows this information.
What is the FDA definition of GxP validation? I see GAMP 5 being pushed around a lot. What about ISO 80002-2 and why not use that over GAMP 5? Thank You for the good work and this webinar.
Hello sir, can you plz share the soft copy.
Have u got this softcopy
@@nileshk4921 no
A very informative yet concise tutorial, thank you for this.
Liked this video, very clear over view of Validation of GxP systems
Difference between csv and software validation
Can you please explain where FQ (functional Qualification) falls in testing or is it different terminology for either IQ, OQ or PQ/UAT ?
Functional Qualification would be the same as OQ, OQ is typically done based on the FRS, PQ on the URS
@@pria209 Do you know how to write test for OQ and PQ? is there any tutorial for that you know?
thank you
Good Information , Please also make more videos on type of documents which is used , with example of testing and validating any hardware/software
Nice presentation on validation
I like your video. I hope these instructions also apply for a free SharePoint Site at www.cloudappsportal.com