When is the Right Time to Archive your Trial Master File?
November 10th, 2021
10am Eastern / 3pm GMT / 4pm Central Europe
The requirement to maintain electronic clinical trial documents and data collected for 25 years or longer brings a lot of questions:
- Have you mapped out a strategy for how this is going to be done?
- What if your system changes, are you going to migrate and if so, how can you be sure to preserve the integrity of the data?
- What if the software that generated your data is now obsolete, have you considered transforming?
Find the answers to these questions and more in this session.
eTMF powered by AI: Automation Benefits and Look at the Future
October 13th, 2021
10am Eastern / 3pm GMT / 4pm Central Europe
Since first bringing AI-powered automation to TMF Management, Phlexglobal has continued to refine and improve PhlexTMF's' ability to automatically classify documents.
As our neural networks learned through real-life practice, so have our capabilities.
Join us for this groundbreaking look into the next stage of TMF automation and a view into the future of TMF management.
PhlexRIM 2.0
The First Regulatory Platform with Built-in Process Automation
August 25th, 2021
10am Eastern / 3pm GMT / 4pm Central Europe
Are you looking for an easy to use and intelligent Regulatory Information Management solution? IIt is finally here - the new PhlexRIM 2.0 system will dramatically improve compliance with efficient and effective real-time access to your global registration information.
Join Regulatory experts Jim Nichols and Markus Winter to see how PhlexRIM will help you work faster and smarter, by streamlining business processes to provide a single source of global registration information.
TMF Completeness: Simple Solutions for a Complex Problem
August 11th, 2021
10am Eastern / 3pm GMT / 4pm Central Europe
Trial Master File completeness presents one of the most complex challenges in TMF management. How do you know if you have all the documents in your eTMF if the system doesn't know what should be in it at the start of the trial?
In this session, two of the top technology minds in TMF management will demonstrate and a simple yet innovative way to measure completeness at any point during the trial.
The Bridge Between Clinical & Regulatory:
How CTR and CTIS are Revealing the Need for more Holistic Approaches
July 14th, 2021
10am Eastern / 3pm GMT / 4pm Central Europe
For far too long, Clinical and Regulatory data have been treated like separate entities, missing many potential efficiencies and insights. The European Medicines Agency's Clinical Trial Regulation (CTR) and Clinical Trials Information System (CTIS) will bring major changes to the industry.
Argha Nag joins Jim Nichols to explore a holistic approach to clinical and regulatory data, showing how crossing traditional departmental boundaries can bring new understanding to drug development.
Functional Work Streams: Operationally Preparing your Teams for Successful TMF Inspections
July 7th, 2021
10am Eastern / 3pm GMT / 4pm Central Europe
Inspection readiness is all about preparation. Not just having your documents in order, but also your team. In this session, seasoned TMF expert McKenzie Knudson will share a proven approach to getting your team ready for inspections.
The Vital Role of Trial Master Files in Mergers & Acquisitions
June 16th, 2021
10am Eastern / 3pm GMT / 4pm Central Europe
Mergers and acquisitions are a constant reality in the world of pharmaceutical development. And whether you are a smaller company seeking to merge your research with others, or a large global pharmer planning to expand your pipeline, the Trial Master File is a vital component of bringing those compounds to market.
In this session, noted TMF expert Marion Mays will present the top three things to consider from both sides - those seeking to be acquired, and those seeking to acquire.
TMF Inspections:
Being Prepared
June 1st, 2021
10am Eastern / 3pm GMT / 4pm Central Europe
Trial Master File inspections are a a real part of bringing a drug to marketing. In this session, we will cover how to be prepared through vital inspections readiness activities and core TMF training practices. Heatmaps, Inspection Checklist, CRO Interaction - we will cover every thing you need to know!
IDMP Readiness: Updates and Best Practices
May 5th, 2021
10am Eastern / 3pm GMT / 4pm Central Europe
IDMP (Identification of Medicinal Products) refers to a set of 5 ISO standards designed to standardize the structure and terminology used to describe marketed medicinal products.
Our experts will provide an update on the IDMP Implementation Guide, and a review of the substance, product, organisation and referential (SPOR) program
Most importantly, the session will cover best practices being used by major Pharmaceutical companies to meet this important requirement.
Crossing the TMF Compliance Gap with Inspection-Ready Access for Closed Studies
April 21st, 2021
10am Eastern / 3pm GMT / 4pm Central Europe
It’s a common situation: Your drug study is closed, you need inspection-ready access to the Trial Master File, but your CRO is ready to get the TMF out of their system and wants to send you a zip folder full of documents. What do you do?
In this session, we will explore an innovative new way to ensure your TMF stays secure while remaining accessible to audits and inspectors so you can focus on getting your drug to market and not on finding documents.
When RIM is not Enough: Overcoming the Limitations of Document-Driven Systems
April 7th, 2021
10am Eastern / 3pm GMT / 4pm Central Europe
Explore the next stage of regulatory information management. It's time to move past electronic versions of old paper-based processes and see the efficiency that comes with a data-focused approach.
Streamlining TMF Documentation through Clinical Automation
March 31st, 2021
10am Eastern / 3pm GMT / 4pm Central Europe
Maintaining a healthy TMF means properly filing documents in a timely manner. The answer to this challenge? Automation!
In this session, we will explore how AI technology can be used to implement the latest TMF best practices directly into the system so you can automate time-consuming manual processes.
From Data to Information to Intelligence:
The Intelligent Operational Data Hub and the Future of Connected Technology
March 10th, 2021
10am Eastern / 3pm GMT / 4pm Central Europe
Traditional point-to-point technology integrations are challenging to build, expensive to maintain, and typically only offer an exchange of data. In comparison, An intelligent Operational Data Hub (ODH) offers an environment that connects a multitude of technologies and can infuse them with new value. This approach helps you where, when and for whom data needs to be mediated, shared, enriched and then linked. In this session, we will learn about the power of the Intelligent ODH and how Phlexglobal will use this technology to bring true intelligence to the life sciences industry
Innovation through Integration: Increase Speed without Compromising Quality
March 4th, 2021
10am Eastern / 3pm GMT / 4pm Central Europe
In this session, Oracle's Jim Streeter and Phlexglobal's Karen Roy will take a deep dive into the power that comes with an integration of "best-of-breed" products designed to unify data and overcome the legacy hurdles of clinical development
Reaching the TMF Health Zone 2021: The Power of A.I. and Mobile Technology
February 17th, 2021
10am Eastern / 3pm GMT / 4pm Central Europe
For inspection-readiness, the critical attributes of TMF health are completeness, timeliness, and quality.
To achieve and maintain ongoing TMF health and inspection readiness – the “TMF Health Zone” – requires experienced people trained on effective processes using the right technology.
In this session, updated for 2021, we will explore ways to reach this balance using new innovations like automated document indexing and mobile technology.
Working with Your CRO's TMF: Part 1
January 27th, 2021
10am Eastern / 3pm GMT / 4pm Central Europe
Does your CRO manage your Trial Master File in its own system? There are many things to consider in this model to ensure a properly managed TMF. In Part 1 of this series, our TMF experts will cover the following topics:
- Setting up the TMF
- Ongoing management including the challenge of eMail Classification
- End of Study actions such as migrations and imports
From File to Trial to File: Benefits of an Integrated Clinical and Regulatory Perspective
January 20th, 2021
Explore the value of automation between the Trial Master File (TMF) and Regulatory solutions. This connection can bridge the gap from the clinical trial to the regulatory filing, ensuring consistency of information while reducing duplicated data entry.