Phlexglobal Provides Global Consolidated eTMF Solution to Bayer

Phlexglobal has announced its successful provision of the electronic trial master file (eTMF) PhlexEview to the pharmaceuticals division of Bayer.

From the rapid 9 week period implementation in 2015, it took one year for the comprehensive solution to be deployed across the majority of recent Bayer clinical trials, consolidating documents from partners and vendors. It is used by thousands of worldwide users.

PhlexEview’s implementation included a fully managed new study and user set up, a common trial master file (TMF) structure based on the TMF reference model version 3, multiple input and output streams, as well as centralised 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 programme, which will see the provision of document approval workflows, contract research organisation (CRO) use, and integration with internal Bayer systems for clinical trial management systems (CTMS), electronic data capture (EDC), interactive voice recognition systems (IVRS), contracts, and regulatory submissions.

Phlexglobal has also introduced recommendations on best practice and provided expert resources to provide quarterly ongoing TMF QC services.

Senior vice-president of Client Solutions Karen Roy said: "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."

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