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.