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, we have worked with both 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.
Phlexglobal supports companies with predominantly paper TMFs by providing standardisation of filing, security of filing in dedicated TMF rooms, quality control of content, TMF consolidation and archiving to ensure regulatory compliance.
Phlexglobal is unique in that we offer both an electronic TMF (eTMF) system, PhlexEview, and the associated services, delivered in accordance with our best practice processes. This enables the production of a regulatory compliant eTMF in accordance with 21 CFR part 11. PhlexEview has been presented to Regulatory Inspectors as the primary TMF for our clients.
Taking a consultative approach, Phlexglobal is able to assess existing guidelines, processes and TMF structures and identify where process and productivity improvements can be made. We advise and assist clients in implementing changes to their TMF structures and processes where necessary. Phlexglobal 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 and associated processes, we help to implement the most efficient TMF management processes and workflows whilst maintaining service levels for internal customers and reducing risk for the client.
Quality is 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. Training, through our dedicated department, underpins our delivery.
What our customers say about us…
“Phlexglobal has experience in handling eTMF documents and has this as its core competency. It makes sense to outsource to them.”
– Associate Director of MRP Management, US pharma
“PhlexEview is a very good solution. It is very simple and user friendly. We have trained around 500 people to use it. The training sessions were booked for 1.5 hrs and out of that, around 15 minutes needed to be spent going through the actual user interface. Teams who are starting from scratch have absolutely no issues what so ever with it.”
– Global Head TMF Management, top 25 global pharma
“There are CROs that have the capability to do it, some do have the electronic systems. But there isn’t anybody I know who provides as good a solution as Phlexglobal.”
– Senior Director in Clinical Operations, top 20 global pharma