Amersham, Buckinghamshire, UK and Malvern, Pennsylvania, US
Phlexglobal, pioneers in the provision of Trial Master File (TMF) technology and services for the global life sciences industry announces the release of the Completeness Quality Control (CQC) module as part of PhlexEview®, its market leading eTMF solution.
Phlexglobal has taken its exclusive, in-house best practice TMF quality technology and made it available as a unique product module of PhlexEview. Building on existing PhlexEview functionality, the CQC module takes TMF management and oversight to another level replacing manual processes with robust in-line technology to facilitate planning, execution, oversight, closure and archive of the TMF. The CQC module provides the tools to conduct regular, risk based or milestone driven completeness reviews within the eTMF system, enabling an up-to-date picture of the quality, completeness and timeliness of a TMF to support inspection readiness.
Firmly integrated with PhlexEview’s powerful workflow capabilities, the flexibility of the CQC module allows statistical sampling for reviews and automated cross checks between related documents, associating them to trial milestones and events. The Investigational Product (IP) release to site process can now be fully managed within PhlexEview; using the CQC module to package, review and approve documents.
Oversight is enabled by the CQC module’s unique TMF Heatmap technology, allowing visualization of real-time metrics on the quality, completeness and timeliness of your TMF down to zone, section, artifact, owner and submitter. In addition, built in reporting tools allow for deep insight into CQC data for trend analysis, issue specifics and remediation management.
The CQC module is also integrated with PhlexEview’s eQuery capability so queries are automatically categorized and tracked, supporting comprehensive reporting and management of findings through to remediation. Working with PhlexEview’s placeholder feature, any missing document findings can automatically create placeholders through events. This flexibility allows clients to configure the CQC module to meet both client and trial specific requirements, supporting TMF inspection readiness.
CEO Rick Riegel said “Phlexglobal has applied its unrivalled experience and expertise to create this innovative CQC module. Over a million TMF documents have already been through our CQC service, for ongoing, milestone, pre-inspection and end of study CQC, with more than 160 trials reviewed.”
The CQC module will be showcased in a webinar featuring a live demonstration of the module as part of the latest version of PhlexEview 4, on Tuesday 25th April 2017 at 3pm BST/ 4pm CET/10am EST. To register for the webinar please visit our website at: http://www.phlexglobal.com/webinar-phlexeviewqc/
For further information, contact:
Gillian Gittens, head of marketing, Phlexglobal Ltd
Tel: +44(0)1494 720420
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