Insights from Experts

Phlexglobal Webinar Series

TMF Afterward: Ask the Experts

Presented by FIERCE Life Sciences


Following the success of the Global TMF Summit, FIERCE Life Sciences is hosting  an exclusive post conference roundtable event on Wednesday, December 2.  Join TMF Experts from Phlexglobal, as well as the Chairperson of the Summit, Karen Roy, as they address unanswered questions from the meeting and deep dive into key takeaways from the Summit.

The session will feature insights from TMF Experts including: 

  • Aaron Grant, VP Solutions Consulting
  • Eldin Rammell, Head of Quality Assurance
  • Marion Mays, VP Business Development
  • Richard Shore, Director Client Solutions

Join us in this unique opportunity to ask any outstanding questions and receive answers in real-time.  to hear about real experiences, strategies, and top tips on a range of topics for you to achieve TMF Health.

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The Journey from File to Trial: Automating Regulatory to TMF

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In this webinar, we will 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..

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Leveraging your TMF as an Oversight Tool

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The Trial Master File, one of the most important elements of a clinical trial, can provide a useful tool for CRO  oversight. Join us for this thought-provoking webinar as we explore ways to increase overall clinical trial quality. 

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Validating an AI Solution with a Focus on Clinical and Regulatory

On Demand

2020_06JUN_04 Validating an AI Solution with a Focus on Clinical and Regulatory

Artificial Intelligence is the future of technology. But how do you ensure that AI solutions will meet regulatory standards? In this webinar our experts will explore the necessary steps to validate your system. 

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TMF Outsourcing:
Fitting the Model to the Sponsor Model

TMF Outsourcing Webinar

A Joint Presentation by LMK Consulting and Phlexglobal

In this webinar, we will explore the advantages and challenges of various TMF models such as CRO-led, Study Owners, Dedicated TMF Department and how outside, expert help can improve TMF Health in each situation

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New Insights into COVID-19 Drug Development

Wednesday, May 20, 2020 | 10am Eastern  /  3pm GMT / 4pm Central Europe

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On April 1st Phlexglobal presented a webinar on solutions to COVID-19 business continuity and fast track trial challenges. On May 7th we will hold an updated presentation covering new information on this vital topic.  

Who should watch: Clinical and Regulatory executives affected with business continuity issues and/or are working on COVID-19 trials

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Watch the April 1st Webinar On Demand

How Digital Disruption Is Shaping TMF Technology to Drive TMF Health

How Digital Disruption Is Shaping TMF Technology to Drive TMF Health

The TMF world has evolved from paper to file share to electronic... what is next? In this digital world it makes sense for TMF to follow the same path. In this presentation, Chief Strategy Officer Karen Roy  will share her insights into the future of TMF technology. 

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Leveraging Automation for IDMP Readiness

IDMP Webinar On Demand

IDMP (Identification of Medicinal Products) refers to a set of 5 ISO standards - ISO 11615, ISO 11616, ISO 11238, ISO 11239 and ISO 11240 – designed to standardize the structure and terminology used to describe marketed medicinal products.  While IDMP presents a challenge, forward-thinking organizations are looking at IDMP as an opportunity to dramatically improve data processes across the regulatory lifecycle by utilizing advanced technologies such as AI-driven automation.

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Using Habits to Counter COVID-19 Stress and Support TMF Health

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The Covid-19 crisis has led to unprecedented changes in procedures and communications, impacting the ability of staff to focus on being productive while juggling competing demands.  Companies are leveraging their teams’ ability to work from home, but this has its own disadvantages. Everyone is working under incredibly high stress loads and distractions.

During this webinar you will learn how to inspire corporate, departmental and individual compliance. We will examine how to create a culture of compliance and how to include inspection readiness into daily operations.

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TMF Trend Analysis: Top 5 Inspection-Readiness Mistakes (and how to fix them)

Top 5 Inspection-Readiness Mistakes (and how to fix them)

As regulatory agencies continue to issue updated TMF guidance and tighten enforcement around the Trial Master File, we expect to see an increase in critical findings. 

Join us to get practical tips on how to improve inspection-readiness in your organization – avoiding the most common mistakes organizations make regarding TMF quality, completeness, and timeliness.

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Solutions to COVID-19 Business Continuity and Fast Track Trial Challenges – Clinical and Regulatory Aspects

COVID-19 Webinar

COVID-19 presents a global challenge to our health and economic well-being. As pharmaceutical companies race to find a cure, they must still follow proper trial procedures to ensure patient safety and trial legitimacy. Additionally, government measures to control the spread are straining many companies resources, causing disruptions in normal documentation practices. Join Phlexglobal experts as they share their insights into ways to accelerate your COVID-19 studies and ensure business continuity for existing active trials

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Dismantling Data Silos to Improve Study Startup and Mitigate Risk

Oracle + Phlexglobal

The focus on technology as a driver of performance improvement in clinical trials is intense, but despite years of valiant efforts, study execution remains far from optimal. For study startup, the data are dismal.

As emphasis shifts towards process optimization, it may be only part of the solution. Point solutions can hinder the flow of data across the continuum, causing already entrenched silos to dig in further. To improve performance quality in study startup, two factors are needed: an end-to-end solution and support from top management.

Unfortunately, entrenched silos such as site identification, clinical development, data management, contracting and regulatory affairs have long stymied these data flow efforts because these departments often have minimal understanding of what is needed downstream.

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How Automation is Transforming Regulatory Compliance in Life Sciences

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Becoming data-centric and mastering digital transformation is the most important topic for life sciences organizations of all sizes. Many companies have reached a plateau of digitalization. While compliance is a key driver for technology investments, the ROI objectives, user adoption and process automation in many companies still have room for improvement.

Join us to find out how we are helping clients to master their digital agenda via proven AI solutions.

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The Importance of Contemporariness and an Approach to Mitigate Audit Findings

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Clinical research professionals have an obligation to uphold the highest ethical standards and strive for compliance with Good Clinical Practice (GCP). Contemporariness is not new as it comprises the first “C” in the ALCOA-C guidance, but recent regulatory guidance from the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) has created new challenges and uncertainty within the industry with regard to its implementation in a trial master file.

Contemporariness is not just isolated to the trial master file, it presents a problem to multi-country studies spanning numerous regulatory agencies. The key challenges arise from not having clearly defined contemporariness in operational SOPs intended to ensure trial master file completeness; this has resulted in MHRA audit findings.

In an attempt to address the issue of contemporariness, sponsors and contract research organizations (CROs) have relied on resource-heavy and costly time-stamping of all incoming site correspondence to start the measure — but does this address regulatory concerns?

In this free webinar, the featured speakers will explore:

  • How contemporariness can be defined in operational SOPs
  • How contemporariness can be implemented in daily operations
  • How to measure and document contemporariness
  • Ensure audit readiness with regards to contemporariness

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What Rules and Regulations are doing to TMF Management 

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Learn how to ensure you are complying to the regulations. With the EMA Guideline on the content, management and archiving of the TMF (paper and/or electronic) finally becoming official, join our webinar for a detailed assessment of the guidance. 

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Managing TMF Migrations

TMF Migrations

TMF Migrations are an important component of many eTMF implementations. One of the biggest challenges facing the industry today is the rapid and accelerating shift from paper to electronic processes—with eTMF being a prime example.

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Transforming Guidelines for TMF Quality into Inspection Readiness Habits

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Whether we like it or not inspections are a crucial part of clinical trials, and it is extremely important that all companies are ready and properly follow GCP guidelines. Being in a constant state of readiness allows companies to be organized and effective in advance of, during and after an audit. The challenge is to be “in control” of compliance while also balancing risk, quality and cost. The answer is to think pragmatically and get to the ‘just-right’ compliance level. 

During this webinar you will learn how to inspire corporate, departmental and individual compliance. We will examine how to create a culture of compliance and how to include inspection readiness into daily operations.

Watch On Demand

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