Whether we like it or not, inspections are a crucial part of clinical trials. It...
PhlexEarchive features long term preservation PDF/A and XML format for documents and metadata and meets regulatory requirements.
The archive includes three secure copies of data, restricted access, 24 hour document retrieval, and data integrity.
PhlexEarchive transforms trial master file (TMF) documents into PDF/A format and creates a standard XML backbone for associated metadata, which are both stored offline with Phlexglobal partner Arkivum using its A-Stor Pharma digital archiving service.
The archive is a secure and electronic system, which enables long-term preservation of electronic content and reduces maintenance costs for servers, operating systems, and application software.
PhlexEarchive improves document security by reducing the chance of accidental or deliberate damage, change, or loss.
With more than 8,000 worldwide users, PhlexEview is the leading regulatory compliant and hosted solution for managing, organising, and displaying TMF documents, enabling users to enhance work practices, while increasing efficiency through the use of specialised software.
Features include internet access, a user-friendly interface, centralised documentation, secure electronic backup, third party integration capabilities, enhanced flexibility, multiple quality control (QC) workflows, advanced reporting. and eTransmittal.
PhlexEview can be used to provide an electronic investigator site file (eISF) enabling the site and monitor to view centralised documents.
PhlexEview features include:
- Single point of submission
- Supports remote monitoring
- Reduced paper and files held on-site
- Pharmacy access to single electronic system
- Inspection readiness checks without visiting the site
- Secure access via restricted user profiles
- Comprehensive site training and support
- Customisable TMF structures and TMF reference model as standard
Phlexglobal offers a wide range of trial master file (TMF) related services, supported by a...
Phlexglobal has announced that it is joining fellow experts at DIA’s eDM Clinical and Regulatory Operations Forum....
Phlexglobal's Client Solutions group offers expert consultancy, which leads to successful trial master file (TMF)...