Phlexglobal Launches A Unique Electronic Trial Master File Solution For The Pharmaceutical Industry
Embracing e-clinical with a 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 - PhlexEviewTM.
PhlexEviewTM, 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 PhlexEviewTM 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 PhlexEviewTM 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 PhlexEviewTM 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 using free 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 PhlexEviewTM process; all tasks are undertaken by qualified personnel. The PhlexEviewTM solution allows flexibility regarding company workflow processes, location, resource allocation and exporting of documents to other systems to assist eCTD preparation.
As an additional service, Phlexglobal can also perform quality control checks on the TMF documentation and prepare it for archive. Phlexglobal is promoting its PhlexEviewTM solution at the Partnerships in Clinical Trials conference in Amsterdam in November (Stand 62). Karen Roy, Head of Business Development, and Chris Butter, Head of IT, will be available to carry out demonstrations at the stand.
Karen said: “Ultimately, PhlexEviewTM 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 PhlexEviewTM from other information access products in the clinical trial industry.
For further information about the PhlexEviewTM solution, log onto
www.phlexglobal.com and contact Karen Roy on
[email protected]. To arrange a meeting and PhlexEview™ demonstration at the Partnerships in Clinical Trials conference, please email Karen Roy.
