Phlexglobal

Electronic Trial Master File (eTMF), e-Archiving and Data Storage Solutions

Mandeville House, 62 The Broadway, Amersham, HP7 0HJ,Buckinghamshire, United Kingdom

Mandeville House, 62 The Broadway, Amersham, HP7 0HJ,Buckinghamshire, United Kingdom



TMF solutions and services

Phlexglobal are the trial master file (TMF) experts and pioneers in the provision of innovative, flexible and technology-enabled TMF solutions and services.

A specialist provider of electronic trial master file (eTMF) solutions and other support services to the global clinical research market; we offer a unique combination of technology, quality and services that deliver a range of flexible, targeted solutions to the life science industry.

Clinical trial administration and TMF technology for the life sciences industry

The company offers a unique combination of TMF technology, quality and services to deliver a range of flexible, targeted solutions to the life sciences industry.

Phlexglobal works with commercial and non-commercial organisations, pharmaceutical and biotech companies, as well as full service contract research organisation (CROs).

The company promotes TMF excellence by focusing on efficient management of clinical trial documents, paper and electronic documents.

By working with large and small organisations on a global level, Phlexglobal has gained a detailed understanding of accurate and complete TMF, enabling the evaluation of a clinical trial.

TMF consolidation and archiving to ensure regulatory compliance

Phlexglobal supports clinical research companies with predominantly paper TMFs, which are considering moving to an eTMF system.

The company provides standardisation of filing, security of filing in dedicated TMF rooms, quality control of content, TMF consolidation and archiving to ensure regulatory compliance.

PhlexEview is the company’s leading eTMF management solution, with associated business processing services also available. These solutions enables production of a regulatory compliant eTMF, in accordance with 21 CFR part 11.

PhlexEview is the leading choice for managing, organising, and displaying TMF documents and implemented more than competitor systems.

With thousands of worldwide users, PhlexEview enables users to enhance work practices, while increasing efficiency, through the use of specialised software, as well as experienced support and optimised processes.

Next-generation business intelligence and analytical eTMF module

The PhlexEmetrics module enables users to gather critical information at a glance. Developed in collaboration with Phlexglobal’s client base, the module offers an intuitive and easy-to-configure eTMF solution to risk-based management.

Using business intelligence and built on clear, concise visual dashboards, users can quickly progress, identify issues and drill down to expose the root cause and analyse details.

Three key dashboards include PhlexEview insight, partner oversight and eTMF completeness, which provide instant cross-study understanding and the ability to filter, by specific study datasets, down to document level for in-depth analysis.

PhlexEview offers eTMF content metrics, partner document submission trends and milestone completeness detail.

Electronic solutions for investigator site documents

PhlexEisf allows investigators, study nurses and pharmacy staff to create and view documents, as well as submit paper or electronic documents with ease anywhere and at any time, using an intuitive user binder style interface.

Using the company’s specialist software, PhlexEisf enhances productivity and ensures users are using electronic importer security filing (ISF) effectively and efficiently.

Long-term preservation of electronic content

PhlexEarchive enables electronic archiving and reduces the costs of maintenance for servers, operating systems and application software. Security can be improved through e-Archiving by reducing the risk of accidental or deliberate change, damage or loss.

PhlexEarchive involve transforming content, including TMF documents into portable document format (PDF) / A format and creating a standard XML backbone for associated metadata.

Both are stored offline with Phlexglobal’s partner company Arkivum, using A-Stor Pharma digital archiving service.

Quality Control Services

Phlexglobal has a wide range of experience with trial master file (TMF) and electronic trial master file (eTMF) requirements from a regulatory authority perspective.

TMF Consultancy – Client Solutions

Phlexglobal provides advise and assists companies in how to re-engineer their business resulting in greater efficiency and regulatory compliance.

PhlexEview4 The Smart eTMF Solution

With an all new simplified study set-up, PhlexEview features an easy-to-answer wizard-driven set-up, which defines completeness requirements automatically.

TMF Services

Phlexglobal offers a wide range of trial master file (TMF) related services, supported by a combination of clinical trial knowledge, document management skills, regulatory understanding and technical expertise.

Client Solutions

Phlexglobal's Client Solutions group offers expert consultancy, which leads to successful trial master file (TMF) management.

Phlexglobal Announces Karen Roy as Chief Strategy Officer

Phlexglobal has announced the appointment of Karen Roy to chief strategy officer. In 2007, highly-respected trial master file (TMF) thought leader Karen Roy joined Phlexglobal as chief business development officer and since 2015 she has led Phlexglobal’s global client solutions team.

Version 3.0 of the Trial Master File Reference Model is Here

Building on the most widely leveraged standardized reference in TMF management today, with version 2.0 used by more than a hundred life science sponsors, CROs and technology vendors, version 3.0 of the TMF Reference Model (released at the DIA Annual Meeting in Washington, DC on June 16th) incorporates feedback from its extensive industry use to enhance content clarity.

Phlexglobal

Mandeville House

62 The Broadway

Amersham

HP7 0HJ

Buckinghamshire

United Kingdom

+44 1494 720420 www.phlexglobal.com