Phlexglobal is a specialist provider of technology-enabled, Trial Master File (TMF & eTMF) document management solutions and other support services to the global clinical research market. We offer a unique combination of clinical trial knowledge, document management skills, regulatory understanding and technical expertise to deliver a range of flexible, targeted solutions to meet business needs.
Phlexglobal Mission Statement
To remain the TMF experts and to continue to lead the TMF arena
To be worldwide pioneers in the provision of innovative, flexible, technology-enabled TMF solutions and services
Expertise We are the TMF Experts; our greatest assets are our talented people and our innovative technology
Quality We are focussed on quality; it underpins our technology and services, and drives our people to be the best that they can be
Integrity We are committed to the highest ethical standards; demonstrated through the way we conduct our business, develop our people, and support our clients
Passion We are passionate about our business, our people, and our clients; driving innovation, flexibility and excellence in everything we do
From our establishment in 1997, Phlexglobal has worked with commercial and non-commercial organizations, Pharmaceutical/Biotech companies and full service CROs to promote the importance of excellence in clinical trial administration, with a focus on efficient management of clinical trial documentation, paper or electronic. Our work has spanned across large and small organizations globally giving us a detailed understanding of the importance of an accurate and complete Trial Master File (TMF) to enable the evaluation of a clinical trial.
Since then the TMF industry has shifted, with more and more documents being electronic. When the TMF was predominantly paper, Phlexglobal supported companies with paper TMFs by providing standardization and security of filing in dedicated TMF rooms, plus quality control of TMF content, TMF consolidation and archiving to ensure regulatory compliance. Phlexglobal is unique in that since 2007 we have offered both a best in class eTMF system in PhlexEview, and all associated TMF services. This enables the production of a regulatory compliant eTMF in accordance with 21 CFR part 11. The most mature eTMF on the market, PhlexEview has been presented to a wide range of Regulatory Inspectorates as the primary TMF for many of our clients.
Taking a consultative approach, our expert Client Solutions group led by Karen Roy, is able to assess existing TMF guidelines, processes and structures and identify where process and productivity improvements can be made. We advise and assist clients in bringing change where necessary. Client Solutions can provide the expertise and operational support to ensure the successful implementation of complete TMF management outsourcing. Working with either PhlexEview or client-chosen systems, we help to implement the most efficient TMF processes and workflows whilst maintaining service levels for internal customers and reducing risk for our clients.
Quality has always been an integral part of our work ethos and our quality management system ensures the appropriate policies, processes and procedures are in place to comply with relevant industry and government regulations.
What our customers say about us...
Director, Business Operations, top 15 global pharma
Global Head Regulatory Document Management , top2 global pharma