White Papers, eBooks, Infographics and Briefs

Solutions from the Experts

Faster, Better, Easier: AI-Assisted
Indexing Improves TMF Management

Case Study AI for TMF

The timely and accurate filing and indexing of documents for the Trial Master File is one of the most significant compliance challenges facing organizations today. In this exciting case study, you can learn how Phlexglobal’s advanced machine learning technologies reduced a pharmaceutical company’s document processing time by 16% while achieving 95% classification accuracy. 

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10 Key Steps to Help you Prepare for IDMP Compliance

IDMP Checklist on Table

Is your organization ready for IDMP? With the publication of the EU Implementation Guide v2.0 on February 22 2021, time is running out for companies with more than one or two marketing-authorized products in the EU to prepare effectively.

Download our free guide, “10 Key Steps to Help You Prepare for IDMP Compliance,” to benefit from Phlexglobal’s experience helping some of the world’s largest pharmaceutical companies prepare for IDMP.


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EMA Mandates Electronic VNeeS Submissions

3 Things to Know and 5 Things You Can Do Today

VNeeS Decision Guide

In October 2020, the EMA guidance v2.7 for Veterinary Non-eCTD Electronic Submissions (VNeeS) came into force. As a result, animal health manufacturers will now be required to use an electronic format for all submission types.

To help prepare for this, Phlexglobal guide to VNeeS version 2.7, "3 Things to Know, and 5 Things You Can Do Today."

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Industry Survey Results & Expert Analysis


Survey Results White Paper on Tablet

Discover insights from your peers and industry experts in this comprehensive analysis from Phlexglobal’s Innovation Tour – a journey through the world of clinical and regulatory innovation.

With a total of 1503 unique responses from our attendees, representing 401 unique companies in North America, Europe, the United Kingdom, and Asia, this white paper offers unique perspectives on how organizations are managing compliance for everything from the Trial Master File and eCTD, to GCP renovation and IDMP/SPOR. 

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Trial Master File

PhexTMF+ Decision Guide Tablet

This guide is designed to help life science organizations make an informed decision around a complex question: whether to outsource some or all of their Trial Master File management to a third-party provider. Based on Phlexglobal’s extensive experience encompassing TMF software, services, and compliance best practices, we have put together a pragmatic set of criteria to consider before you make this critical decision.


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Becoming Truly Digital: How Artificial Intelligence is Transforming Compliance in Life Sciences
As featured in Innovations in Pharmaceutical Development 


The INNOVATE® publishing series is a 350-page in-depth study and AR video series that showcases the people, companies, products, and services that are leading the race within a cities innovation and entrepreneurial ecosystem.

Phlexglobal is proud to be featured with both a company profile and an article by CSO Karen Roy. 

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Read Karen Roy's Article


Simplify Compliance While Delivering Ongoing TMF Health - A Phlexglobal Infographic

Infographic - PhlexTMF+ Full-Service TMF Management

Learn how PhlexTMF+ provides all the components required for expert TMF management to ensure quality, completeness, and timeliness of your Trial Master File


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Clinical & Regulatory Robotic Process Automation: The Transformation from Compliance Enablement to Compliance Automation

Automation Brief

Discover best practices for leveraging artificial intelligence to make clinical and regulatory compliance faster and more accurate, with less effort and cost.

You will also get valuable lessons learned from your peers, with real-world AI use cases that include:

  • AI-Assisted Indexing Improves Speed and Accuracy of TMF Document Processing
  • IDMP Data Mining at a Top 20 Pharma
  • Streamlining Health Authority Communications at a Top 10 Pharma
  • Increasing Regulatory Submission Efficiency and Quality for a Top 5 Pharma

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New Developments in IDMP: What You Need to Know, and What You Can Do Today

IDMP Executi8ve Brief Computer Screen

With the EMA expected to be the first health agency to mandate compliance with ISO IDMP (with the FDA not far behind), organizations face a rapidly shortening timeframe to prepare for this the highly complex compliance mandate.

Download Phlexglobal’s latest executive brief, “New Developments in IDMP: What You Need to Know, and What You Can Do Today.” You’ll benefit from our extensive compliance and technology expertise in life sciences, as well as Phlexglobal’s experience helping some of the world’s largest pharmaceutical companies prepare for IDMP.

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Digitalization and Automation in Life Sciences

Automation Infrographic thumbnail3

Becoming data-centric and mastering digital transformation is the most important topic for life sciences organizations of all sizes. However, Many companies have reached a plateau of digitalization and are not taking advantage of available automation technology. Download this infographic to learn what it means to be data-centric and the five things you should expect from Automation technology.

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Three eTMF Case Studies: Why CROs and AROs Are Choosing Phlexglobal

Infographic Computer ScreenCRO Case Studies

Download the executive brief, “Three eTMF Case Studies: Why CROs and AROs Are Choosing Phlexglobal” to learn why selecting Phlexglobal makes the most business sense, including:

  • Improved TMF quality and operational efficiency from the industry’s only advanced eTMF SaaS solution built around the business practices of CROs and AROs
  • Phlexglobal’s unique fit-for-sponsor requirements around TMF management and inspection-readiness to help reduce risk
  • Phlexglobal’s flexibility and scalability to support global or regional trials worldwide, easily encompassing thousands of users and millions of documents across hundreds of studies 

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5 Reasons Why CROs are Choosing Phlexglobal to Build a Successful eTMF Practice

Image CROs choose Phlexglobal eTMF

Download the infographic “5 Reasons Why CROs Are Choosing Phlexglobal’s eTMF”  to get learn why CROs and AROs are turning to Phlexglobal, such as:

  • The industry’s only advanced eTMF SaaS solution built around the business practices of CROs and AROs
  • Pre-configured, CRO- and ARO-specific workflows to accelerate time-to-value and streamline TMF operations
  • Phlexglobal’s commitment to a genuine partnership and support to help your customers achieve ongoing compliance and inspection-readiness

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Reduce Risk and Improve Inspection-readiness with Expert TMF Document Processing

Infographic Computer Screen Veeva Services

Download the infographic, “How to Improve TMF Document Processing Speed and Quality” to learn why companies worldwide are relying on Phlexglobal’s leadership in TMF best practices to:

  • Get an average 95% “right the first time” document processing accuracy, regardless of volume or system
  • Benefit from the latest techniques such as risk-based QC and advanced workflows to accelerate identification and remediation of inconsistent or missing documents and metadata
  • Improve inspection-readiness through expert quality review and completeness assessments
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Improve TMF Management and Inspection-Readiness with PhlexTMF eTMF Software

Infographic PhlexEview eTMF

Download the infographic, “Improve TMF Management and Inspection-Readiness with PhlexTMF” to discover why sponsors and CROs worldwide have chosen Phlexglobal’s best-of-breed eTMF software to:

  • Obtain critical insight that drives effective TMF management – improving overall TMF health and inspection-readiness
  • Easily monitor the quality of internal or outsourced studies
  • Get a real-time view into completeness according to the protocol and study milestones

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From Chaos to Order: Your Expert Guide to TMF Migration Planning

From Chaos to Order in 3 Steps - Phlexglobal Guide to Planning TMF Migration_Page_1

The guide is built on Phlexglobal’s years of experience conducting hundreds of successful migrations, for organizations ranging from small biotechs to the industry’s largest sponsors and CROs. Distilling our expertise across all types of migration scenarios as well as source and destination environments, the guide offers you core best practices that streamline TMF migrations while improving quality.

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5 Reasons your TMF Isn't Inspection-Ready (and what you can do to fix it.)

Learn to Avoid the Most Common Inspection-Readiness Mistakes



Based on helping companies pass hundreds of inspections by regulatory agencies worldwide, the guide will help you identify and correct those areas most often flagged by inspectors, including:

  • Lack of essential documents in the TMF required to enable the reconstruction of trial events and demonstrate compliance
  • Inability of sponsors to demonstrate effective oversight of clinical trial activities to fulfil their regulatory obligations
  • Insufficient functionality in the eTMF system used

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From Liability to Asset: A Trial Master File Rescue

A Case Study on the Importance of TMF Health

Phlexglobal A TMF Rescue White Paper

Learn how Phlexglobal helped a global biopharmaceutical company quickly turn a poor-quality Trial Master File into an inspection-ready asset through:

  • Complete inventory of all content and rapid, accurate conversion of documentation to usable, digital format aligned with the TMF Reference model
  • Detailed Quality Review of all documentation, with high-level heatmaps for executive overview and granular line-by-line detail for taking action
  • Full gap analysis to identify missing documentation, together with a risk-based remediation plan
  • Visibility to progress throughout the conversion to the TMF, with early identification and prioritization of critical items for corrective action

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Reaching the TMF Health Zone: Expert Guidance from the TMF Authority

Reaching and Maintaining Ongoing TMF Health is Possible. We can show you how. 

Reaching the TMF Health Zone White Paper

For over 20 years, Phlexglobal has helped organizations from Top 20 biopharmaceutical companies and the world’s largest CROs, to small biotechs and specialty CROs, achieve Trial Master File quality, completeness, and timeliness. Dedicated solely to TMF best practices in both software and services, we have a unique perspective on the core requirements to achieving ongoing TMF Health and inspection-readiness: what we refer to as the “TMF Health Zone.”

We have summarized this extensive knowledge into core principles, to provide pragmatic guidance on how to best reach the TMF Health Zone.

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10 Things You Should Know About The New TMF Regulatory Guidance

The new EMA TMF Guidance is now in effect. Are you ready?

2019 EMA Guidlines

The European Medicines Agency (EMA) guidance on Trial Master Files took effect on June 6, 2019 and promises to have far-reaching impacts on an organization’s TMF processes, technology, and best practices – as well as related departments and systems. 

Phlexglobal is offering this free guide by renowned TMF expert Eldin Rammell to help you better understand the impact this can have on your TMF management processes. 

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Recommended Trial Master File Habits by Role

Phlexglobal Inspection Readiness Habits

To do inspection-readiness well and make it stick, you need a plan that goes beyond learning about the regulations and writing new procedures, more than developing metrics and creating dashboards, more than creating another online learning module. You need to consider human behavior and how we fail to develop habits that take care of our future selves, or in this case, our TMF deliverables.

This infographic outlines cues and actions, rewards, and routines for key positions relevant to TMF Health. To learn more about creating good TMF Habits, read our blog How to Transform TMF Quality Guidelines into Inspection-Readiness Habits or watch the on demand webinar featuring TMF expert Mark Webb.

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