Join us for Innovation Tour 2021:

PhlexRIM 2.0
The First Regulatory Platform with Built-in Process Automation

August 25th, 2021
10am Eastern / 3pm GMT / 4pm Central Europe

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.