Overview
Quality
Flexible, free text search facility
Enhanced project communication
Management tool
Resource efficiency (no end-of-study reconciliation)
Four options
PhlexEview™ is Phlexglobal’s unique electronic Trial Master File (TMF) solution for the Pharmaceutical Industry.
PhlexEview™ is an end-to-end process which enables the electronic searching and viewing of Trial Master File documentation. Documentation from Sponsors, Subsidiaries, CROs and field-based personnel is centralised from the start of a clinical trial and available for viewing, avoiding the usual end of study TMF reconciliation difficulties. PhlexEview™ is very simple and logical to navigate, so training requirements are minimal.
As an overview of the process each individual document is prepared, scanned and indexed, according to the agreed TMF structure. The indexed documents are synchronised to a server located in a secure hosting environment and, through the PhlexEview™ search facility, documents are available for viewing and downloading over the internet. End users can log in through a secure website from anywhere in the world with an internet connection to view their Trial Master File. 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. As an additional service, Phlexglobal can also perform quality control checks on the TMF documentation and prepare it for archive.
PhlexEview™ isn’t just for paper; all types of electronic documents including emails can be added to the system once they have been indexed to allow for searching. Phlexglobal can also take responsibility for printing and filing the paper versions of the electronic documents in the TMF.
Quality is a key feature of the PhlexEview™ process; all tasks are undertaken by qualified personnel. For the scanning element of the PhlexEview™ process, to ensure that the images produced are of the highest possible standard, quality control checks are made to 100% of the documents. Each image is individually examined by a trained Document Administrator and any corrections are made immediately. This process eliminates any inconsistencies between the original hard copies and the electronic copies, ensuring that all images appear on screen exactly the same as the original document. After the indexing is complete, the documents are subjected to a further defined quality control process looking at the preparation, scanning and indexing of the documents.
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, types of files (central study file or investigator files), centres, sections, or sub-sections, with the additional facility of advanced searches using free text, date of document and date of synchronisation. The free text search (generally referred to as optical character recognition) will find any word specified in the search field. Each document is assigned a date according to agreed conventions and each document shows the date it was synchronised to the viewing server. Search results can be ordered by date or section for ease of review. The system can be configured for specialised pre-set searches for defined documents.
Communication is enhanced with the use of PhlexEview™. Regardless of location, project teams will have visibility of all documentation. Through user profile log-in, restrictions can also be put in place if certain sections of the TMF should have limited visibility. PhlexEview™ enables the user to perform on-line quality checks of the TMF, without having to travel around the world to accomplish the task.
PhlexEview™ is also a powerful management tool. For example, a Line Manager, Project Manager, Departmental Manager or even an Outsourcing Manager can select all monitoring visit reports from an individual over a certain date range. Alternatively all documents that have been synchronised since a certain date, or between two dates can be selected. Using the information available in the system, a variety of bespoke reports can be produced.
Due to the flexible nature of the system construction, additional modules can be developed to match workflows such as quality control processes or information flow. During the indexing process, certain documents such as drug release documentation can be flagged to allow for easy searching for review.
Resource efficiency is achieved through all the features of PhlexEview™. No end-of-study reconciliation, immediate access to documentation, no travel requirements to view documentation, 24-hour availability and management reports are just some of the features that contribute to this efficiency
The PhlexEview™ process allows flexibility regarding location and resource allocation. There are four options available:
With eCTD on the horizon, PhlexEview™ embraces the Pharmaceutical Industry’s move to an electronic era emphasised by the ability to export documents from PhlexEview™.
It is the specialist combination of document recognition and management, level of quality control, GCP understanding and technical expertise that distinguishes PhlexEview™ from any other information access product.
