17:01 uur 25-10-2016

Phlexglobal biedt Bayer internationaal geconsolideerde eTMF-oplossing

AMERSHAM, Engeland & MALVERN, Pa.–(BUSINESS WIRE)– Phlexglobal, pionier in de levering van Trial Master File (TMF)-technologie en -diensten voor de levenswetenschappen, meldt dat zijn toonaangevende eTMF-product PhlexEview succesvol is als eTMF-systeem voor de farmaceutische divisie van Bayer.

Een jaar na de 9 weken durende implementatie in 2015 is de veelomvattende oplossing geïnstalleerd voor het merendeel van de medische onderzoeken van recente onderzoeken van Bayer. Het systeem consolideert documenten van partners en verkopers en wordt wereldwijd door duizenden gebruikers ingezet. De implementatie van PhlexEview omvatte een volledig ‘managed’ setup voor onderzoek en gebruikers; een algehele TMF-structuur op basis van versie 3 van het TMF-referentiemodel; verschillende input- en outputstreams en rapportage en overzicht vanuit een gecentraliseerd punt.


Phlexglobal provides a global consolidated eTMF solution for Bayer


AMERSHAM, England & MALVERN, Pa.–(BUSINESS WIRE)– 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.

About Phlexglobal

Phlexglobal is a specialist provider of technology-enabled, Trial Master File (TMF & eTMF) document management solutions and other support services. They offer a unique combination of clinical trial knowledge, document management skills, regulatory understanding and technical expertise to deliver a range of flexible, targeted solutions to meet business needs.

More information can be found at http://www.phlexglobal.com



Phlexglobal Ltd
Gillian Gittens, head of marketing
Tel: +44(0)1494 720420
Email: info@phlexglobal.com

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