Are you in the TMF Health Zone?

Don't put your compound at risk. Phlexglobal can help ensure your Trial Master File is Inspection Ready.

Trial Master File Health is often overlooked.

Don't make this mistake!

TMF Healthzone graphic (1)

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. 

Failing to look at the big picture and how these are functioning together leads to major gaps in TMF Health, putting your ability to take your compound to market at risk. 

Phlexglobal's balanced approach to TMF Health helps you

  • Enable active management and inspection-readiness through strategic and tactical visibility into TMF Health
  • Streamline operations to reduce TMF-related time, cost, and resource demands while maximizing compliance with SOPs
  • Gain clear oversight and complete management control over internal and outsourced studies 

 

A Healthy Trial Master File is a clinical trial imperative. 

The regulatory requirements around TMF are increasingly a focus of inspections by FDA, EMA, MHRA and other regulatory authorities.  Trial sponsors have ultimate responsibility for the health or their trials' TMFs. Phlexglobal offers additional advantages including:  

Bring Order, Stability, and Control to your Trial Master File with Phlexglobal.

Obtain oversight and control over every stage of your Trial Master File, and improve productivity and process efficiency, with purpose-built eTMF SaaS software built by the TMF authority.

Improve quality, efficiency, and productivity with expert quality review, inspection-readiness heat maps, technology and process training, and experienced on-site support to augment internal resources as needed.

Optimize TMF processes and leverage high-quality document processing from plan to final archive, according to TMF best practices and the latest regulatory guidelines - while getting the maximum benefit from your TMF team and technology.

Bring Order, Stability, and Control to your TMF

Phlexglobal is unique among eTMF providers.

We leverage dedicated and authoritative TMF technologies and expert services to bring order, stability, and control to your Trial Master File – helping you achieve the highest standards for completeness, timeliness, and quality.

Phlexglobal PhlexEview

Purpose-Built eTMF Technology

eTMF software designed by the TMF experts specifically for TMF requirements, aligned with the TMF Reference Model.  Intuitive design and configurable workflows encourages rapid adoption, and configuration flexibility ensures alignment with your SOPs and best practices.

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Phlexglobal Document Processing

High-Quality Document Processing

Quality-driven document processing in any system helps ensure completeness, timeliness, and accuracy of documents.  Our experienced TMF and technology experts deliver accurate and consistent paper and electronic document processing, remapping, and archival services. 

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Expert TMF Services

Expert TMF
Services

TMF domain experts help ensure your eTMF technology, people, and processes are optimized for TMF health. Get the greatest value from your eTMF, obtain an in-depth review of your TMF, or a risk-based review to identify quality and completeness gaps.

 

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Don't put your compound at risk.

Contact us and we can help. 

Phlexglobal can offer specialist services to validate the health of your TMF.  With 20 years’ standing in the industry we offer both technology and consulting services covering the lifecycle of your clinical documents from setup to archive.  Whether you are looking for an eTMF, would like to digitalise an existing paper TMF, need help in QC of your documents or advice on SOPs, if you are preparing for an inspection or looking to archive a completed study, we offer expertise and solutions. 

Take Advantage of our Expert Advice

Learn more about TMF Health with our on-demand webinars. 

New Habits LR

Transforming Guidelines for TMF Quality into Inspection Readiness Habits

Inspections are a part of clinical trials, and following GCP guildelines will help keep you ready at all times.

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Barry-Sacks-AI

Changing the Face of eTMF with new Technologies

We’ve all heard of the term Artificial Intelligence but how can it be applied to the ever-evolving world of eTMF? Our CTO explains it all. 

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Migrations

Managing TMF Migrations

One of the biggest challenges facing the industry today is the rapid and accelerating shift from paper to electronic processes. Learn strategies to ensure a smooth TMF migration in this presentation. 

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