In the News

Phlexglobal Announces Industry-First eTMF AI that Reduces Risk of Document Misfiles and Metadata Errors to Improve TMF Quality and Inspection-Readiness  

March 20, 2023  


Phlexglobal, a PharmaLex company and the recognized global authority in Trial Master File services and technology,today announced the general availability of PhlexTMF v21: the industry’s only purpose-built eTMF solution with next-generation artificial intelligence that helps ensure clinical documents are “right-first-time” at the critical document upload step
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Trial Master File Reference Model Group Officially Affiliates with CDISC

April 27, 2022


We are pleased to share that Trial Master File Reference Model Group has officially affiliated with CDISC. Read More

PharmaLex expands global footprint capabilities for clinical and regulatory services with Phlexglobal merger

January 25, 2022


PharmaLex Group, a leading provider of specialized services for the pharma, biotech and medtech industries worldwide, has announced the merger with leading technology and services organization for clinical and regulatory solutions, Phlexglobal.

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Cary Smithson Brings Extensive Life Sciences Regulatory Expertise to Help Phlexglobal Customers Navigate a Transforming Regulatory Landscape

November 11, 2021

Cary Smithson

Smithson will provide proven leadership for rapidly expanding regulatory operations team supporting Phlexglobal customers worldwide.

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Phlexglobal Announces Industry’s First RIM Software with Intelligent Business Process Automation to Increase Efficiency and Drive Globally Standardized Compliance

October 26, 2021

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New PhlexRIM 2.0 provides end-to-end regulatory information management, preconfigured automations built around regulatory best practices, and flexibility to map easily to internal processes

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Global Academic Research Organization UCL Selects Phlexglobal’s Innovative eTMF Solution to Enhance TMF Compliance and Inspection-Readiness Across Entire Study Portfolio

July 29, 2021

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Renowned institution providing groundbreaking research for Covid-19 and other critical health needs required rapid transformation from paper-based processes to streamline TMF management

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Phlexglobal eTMF Customers See Double-Digit Time Savings and 95% Accuracy from Industry’s Most Advanced AI-Powered TMF Automation

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Companies significantly increasing speed and accuracy of document processing and quality control with PhlexTMF’s AI-assisted indexing solution trained on millions of Trial Master File documents.

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New Phlexglobal Solution Offers Easy TMF Inspection of Closed Studies, Addressing a Critical Compliance Gap in the Trial Master File Lifecycle

April 13th 2021

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PhlexTMF for Viewing offers secure, accessible and fully compliant cloud-based TMF storage for closed and locked studies received from a CRO or third party.

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5 of the Top 10 Global Pharma Companies Leveraging Phlexglobal's TMF Quality Review to Reduce Time, Cost, and Potential Risks from M&A Activity

April 7, 2021

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Phlexglobal announced today that an increasing number of pharmaceutical companies, including five of the global Top 10, are utilizing Phlexglobal’s innovative TMF Quality Review solution to identify and mitigate potential regulatory risk for mergers & acquisitions and improve inspection readiness.

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Treximo Selects Phlexglobal's Innovative Submission Software as Technology Foundation Supporting Strategic Growth in Regulatory Services

March 25, 2021

Phlexglobal Treximo

Phlexglobal announced today that Treximo, a leading life sciences consulting company and part of The Planet Group, has selected Phlexglobal and its innovative regulatory SaaS software, PhlexSubmission, as the key technology to meet growing customer needs for regulatory submissions. 

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Hope Biosciences Stem Cell Research Foundation Selects Phlexglobal to Support Rapid, Compliant Investigational New Drug Application for COVID-19 Therapy

November 10, 2020

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Rapidly growing research foundation replaced existing eCTD solution with PhlexSubmission to improve the speed, quality, and cost-effectiveness of submission process.

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Version 3.2.0 of the TMF Reference Model Launched

November 2, 2020

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Long-time TMF Reference Model supporter Phlexglobal endorses newest version offering industry-driven updates to improve the quality, consistency, and flexibility of Trial Master File management.

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Phlexglobal Partners with PRA Health Sciences to create the Global TMF Center of Excellence

September 23, 2020 

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Fit-for-purpose eTMF SaaS software and expert services strengthens PRA customers’ confidence that their Trial Master File is compliant and inspection-ready from plan to archive

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Phlexglobal Supports Synairgen’s COVID-19 Clinical Trial with Implementation of Advanced eTMF Solution in Just 16 Days

August 19, 2020

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Innovative respiratory disease company joins more than 15 customers drawing on Phlexglobal’s support to help develop promising COVID-19 therapies and vaccines.

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Phlexglobal Launches Industry’s First Turnkey, End-to-End TMF Management Solution from a Single Expert Provider

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PhlexTMF+ provides a one-stop, full-service solution that encompasses all the software and services required for effective TMF management and ongoing inspection-readiness. Organizations can be confident that their Trial Master File is being managed by experts every step of the way, from planning and document processing and study closeout.

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Phlexglobal and Arkivum join forces to enable Trial Master File data compliance over its entire extended lifecycle

Phlexglobal + Arkrivum

A newly announced technical partnership between Arkivum, recognised internationally for its cross-sector expertise in archiving and digital preservation, and Phlexglobal, a leading provider of clinical and regulatory software and services for the life sciences industry, will enable Phlexglobal’s customers to achieve and maintain compliance over the entire Trial Master File (TMF) lifecycle, covering both the live trial and the statutory upcoming 25-year archiving period – or longer - as required.

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Announcing the Innovation Tour: A Unique Virtual Journey through the World of Clinical and Regulatory Innovation, Sponsored by Phlexglobal

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Phlexglobal customers, partners, and subject matter experts will share proven innovation and pragmatic guidance to help life sciences companies improve end-to-end regulatory compliance

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Phlexglobal Providing Vital Support for COVID-19 Clinical Trials

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Phlexglobal, a leading innovative technology and services provider for the life sciences industry, today announces its substantial contribution to COVID-19 clinical trial activities. Since the outbreak of the COVID-19 pandemic, Phlexglobal has provided extensive support for multiple pharmaceutical companies developing effective treatments for those who have been impacted by the virus and vaccines to prevent its spread. These services are vital to developing life-saving treatments for the most important health crisis facing the world today.

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Phlexglobal Acquires Cunesoft

Authority in Trial Master File management expands offering into Regulatory Information Management and Artificial Intelligence Technology

January 8, 2020

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Phlexglobal, the leading provider of Trial Master File (TMF) software and expert services, today announced the acquisition of Cunesoft, a move that expands the company’s portfolio of best-of-breed technologies designed to provide solution-specific functionality to meet the business objectives of life sciences companies. 

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Oracle Health Sciences and Phlexglobal Collaborate to Reduce Operational Bottlenecks in Clinical Research

October 23, 2019

Oracle + Phlexglobal

Oracle Health Sciences, a leader in eClinical technology and Phlexglobal, pioneers in the provision of Trial Master File (TMF) technology and services for the global life sciences industry, have announced enhanced integrations to accelerate the speed and accuracy of regulatory compliance and inspection readiness in clinical trials.

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Phlexglobal to Host Trial Master File World Forum in the United States and United Kingdom

September 9, 2019

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This Autumn Phlexglobal will host the annual TMF World Forum, two exciting events focused on helping the life science industry, including pharmaceutical companies, clinical research organizations, and medical device manufacturers, meet compliance standards, achieve ongoing TMF Health, and become consistently inspection-ready: what the company refers to as “Reaching the TMF Health Zone.”

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Phlexglobal to Host Summer Seminar Series Focused on Trial Master File Health

July 18, 2019

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Phlexglobal today announced an exciting series of complimentary seminars aimed at helping pharmaceutical companies meet regulatory guidelines and achieve optimum TMF Health.

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Phlexglobal Issues Industry Advisory on New EMA Trial Master File Guidance

June 6, 2019

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 Phlexglobal today announced an important industry advisory around the new European Medicines Agency (EMA) guidance on Trial Master Files. The guidance 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.

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Phlexglobal Names John McNeill as CEO

January 14, 2019

John McNeill

Phlexglobal today announced that its Board of Directors has appointed John McNeill as Chief Executive Officer and member of the Board of Directors effective January 14, 2019. McNeill previously held the position of President at Sparta Systems, Inc.

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Phlexglobal to Improve eTMF Document Transfers with Adoption of New Exchange Mechanism Standard

June 21, 2018

TMF Exchange Mechanism

Phlexglobal, a specialist provider of technology-enabled Trial Master File (TMF & eTMF) management solutions, is adopting Version 1 of the eTMF Exchange Mechanism Standard (eTMF-EMS) of the TMF Reference Model (TMF-RM) into PhlexTMF, the company’s eTMF technology. This marks a major advancement in efficient document interchange and will firmly solidify Phlexglobal’s position as a driving force in eTMF management for clinical trials.

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