Phlexglobal, pioneers in the specialist provision of electronic Trial Master File (eTMF) technology and TMF services to the life sciences industry announces the success of its market leading eTMF, PhlexEview, as the eTMF solution for the Pharmaceuticals Division of Bayer.
One year on from the rapid 9 week period implementation in 2015, a comprehensive solution has been deployed across the majority of recent Bayer clinical trials, consolidating documents from partners and vendors, and used by thousands of worldwide users. PhlexEview implementation included fully managed new study and user set up; a common TMF structure based on the TMF reference model version 3; multiple input and output streams, and centralized reporting and oversight.
Various project milestones have since been successfully achieved. The next step will be the adoption of PhlexEview version 4. This version is set to further improve the worldwide eTMF maturity program, which will see the provision of document approval workflows; CRO use, and integration with internal Bayer systems for CTMS, EDC, IVRS, contracts and regulatory submissions.
Phlexglobal has also introduced recommendations on best practice and provided expert resource to provide quarterly ongoing TMF QC services.
“We are excited to be a partner of Bayer to provide PhlexEview as their full TMF management solution. PhlexEview is providing a global eTMF in one common TMF structure, with CRO oversight metrics, and so much more,” said Karen Roy, senior vice president, client solutions.
PhlexEview is the leading regulatory compliant and hosted solution for managing, organizing, and displaying TMF documents. PhlexEview enables users to enhance their work practices while increasing their efficiency through the use of specialized software.
For further information, contact:
Gillian Gittens, head of marketing,
Phlexglobal Ltd
Tel: +44(0)1494 720420
Email: info@phlexglobal.com
