AMERSHAM, England--Phlexglobal, the specialist provider of Trial Master File (TMF) and electronic Trial Master File (eTMF) expertise, solutions and services for the life sciences industry, has announced a partnership with the data archiving specialist, Arkivum. The partnership will enable Arkivum's A-Stor Pharma digital archiving service to become part of Phlexglobal's end-to-end eTMF solution, PhlexEview.
PhlexEview is Phlexglobal's hosted eTMF system and associated processes, which enables the electronic searching, viewing and reporting on all TMF documentation. It provides complete chain of custody of all documents and by adding in an e-Archiving solution, PhlexEview can now offer complete cradle-to-grave records management. The eArchiving solution can also be provided as a stand-alone solution to non-PhlexEview documents or even clients'.
Karen Redding, global business development director at Phlexglobal and co-chair of the TMF Reference Model, said: "eTMF uptake has recently risen dramatically, but there is a tendency to incorrectly assume that leaving documents in a live system is sufficient to meet archiving requirements. Phlexglobal is actively addressing this by integrating an e-archive solution into PhlexEview to provide a seamless interface for restoring TMF documents for inspection and review purposes. Long-term digital archiving requires specialist expertise, active data management, the procurement and migration of systems to address obsolescence, and regular auditing to meet retention requirements and schedules. Arkivum has these in place and we are delighted to be able to include their digital archiving service as part of our solution".
The regulatory authorities apply exactly the same retention periods for clinical trial documentation and data to both paper and electronic records. These can extend well beyond the usual life expectancy of both hardware and software systems. The information must be 'readily available' on request by the authorities; while access to the documents and data remains controlled and restricted. In the past this requirement for long-term preservation meant some companies were reluctant to implement an eTMF system. The provision of a secure and validated digital archiving service removes this barrier to full implementation of an eTMF system.
Established in 1997, Phlexglobal - The TMF Experts - are pioneers in the global provision of flexible, adaptable and technology-enabled TMF solutions & services. They offer a unique combination of services that deliver support solutions to the pharmaceutical, biotechnology, medical device, CRO and healthcare industries.