PA-PHLEXGLOBAL
20.6.2016 11:37:57 CEST | Business Wire | Press release
Phlexglobal, pioneers in the provision of Trial Master File (TMF) technology and services for the global life sciences industry, will be attending the 52nd Annual Meeting of the Drug Information Association Annual Meeting in Philadelphia US, June 27th to June 29th 2016.
Visit Phlexglobal at DIA at booth #1604 , where the Phlexglobal team including CEO Rick Riegel will be showcasing its flexible technology and services solutions, with a focus on the latest version of its market leading eTMF system, PhlexEview 4. With superior TMF management capabilities, PhlexEview 4 adds intelligent new ways of working designed specifically to increase quality, timeliness and oversight of the TMF. Market and client interest in PhlexEview 4 has been very high. With over 10 existing Phlexglobal clients upgrading to the new version and 2 new companies signed up, PhlexEview 4 is set to take these early adopters to the next level of eTMF maturity.
PhlexEview 4 complements Phlexglobal’s unique and world renowned flexible services model, which allows clients to take on or delegate TMF business processing to Phlexglobal through processing allocation features on a study by study basis and at a moment’s notice.
Karen Roy, Senior Vice President of Client Solutions at Phlexglobal will be chairing the DIA Meeting session on: “eTMF: Selection, Implementation, and What’s Next?” #341, on Wednesday June 29th at 2pm EST. Her session will walk through the steps from vendor selection to global implementation of eTMF software and elaborate on the various work streams that should be established to ensure success.
Phlexglobal will also be promoting its exciting new partnership with LUZ, the world’s leading language translation company for life sciences, offering a full eTMF and document translation solution ensuring regulatory and language compliance for clinical trials. Visit Luz at DIA at booth #1453 .
For further information on Phlexglobal, please contact: info@phlexglobal.com
About Phlexglobal
Phlexglobal is a specialist provider of both industry leading eTMF technology solutions and expert TMF & eTMF technology-enabled services. Offering a unique combination of clinical trial knowledge, document management skills, regulatory understanding and technical expertise, we deliver a range of flexible, targeted solutions to meet business needs.
See more at: http://www.phlexglobal.com
About DIA 2016
DIA 2016 is the largest global interdisciplinary event that brings together key thought leaders and innovators from industry, academia, regulatory and government agencies, health, patient, and philanthropic organizations from around the globe - and across all disciplines involved in the discovery, development, and life cycle management of health care products.
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View source version on businesswire.com: http://www.businesswire.com/news/home/20160620005559/en/
Contact:
Phlexglobal Ltd
Gillian Gittens, head of marketing,
Tel:
+44(0)1494 720420
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