Phlexglobal Embraces e-Clinical With An Electronic Trial Master File Solution

Resource efficient management tool for clinical trials. Phlexglobal Ltd, the specialist CRO for clinical trial administration and study support, has announced the launch of a unique electronic Trial Master File (TMF) solution - PhlexEview™.

PhlexEview™, an end-to-end TMF solution, allows logical electronic searching and viewing of TMF documentation from sponsors, subsidiaries, CROs and field-based personnel. Documentation is centralised from the start of a clinical trial and available for viewing from anywhere at anytime, avoiding the common end of study TMF reconciliation difficulties. The system is very simple and logical to navigate and requires minimal training.

The PhlexEview™ solution involves preparing each individual paper or electronic document; scanning the paper and indexing according to the agreed TMF structure. The indexed documents are then synchronised to a server located in a secure hosting environment and, through the PhlexEview™ search facility, documents are then available for secure viewing and downloading over the internet. The paper TMF documentation can be filed securely in Phlexglobal's TMF rooms, which are fire and environmentally resistant, or can be returned to the user.

The power of PhlexEview™ is in its flexible, free text search facility which makes it easy to locate any document or set of documents required. Searching can be done either within or across protocols, centres or sections, with the additional facility of advanced searches for full text, date of document and date of synchronisation. 

PhlexEview™ delivers a powerful communication tool to the clinical trial management team, offering immediate access to documentation and bespoke management information. Quality is a key feature of the PhlexEview™ process; all tasks are undertaken by qualified personnel. The PhlexEview™ solution allows flexibility regarding company workflow processes, location, resource allocation and exporting of documents to other systems to assist eCTD preparation.

Karen Roy, Phlexglobal's Global Business Development Director says "ultimately, PhlexEview™ is going to promote resource efficiency, improve communication and provide a powerful management tool for the clinical team. No longer will you have to dedicate resource to end of study reconciliation. Reviewing TMFs can be done from any convenient internet connection. Line, project, departmental or even outsourcing managers can produce bespoke searches to give them detailed insight into the management of studies."

It is the specialist combination of document recognition and management skills, level of quality control, GCP understanding and technical expertise that distinguishes PhlexEview™ from other information access products.