AMERSHAM, England and MALVERN, Pa.--(BUSINESS WIRE)--Phlexglobal, pioneers in the specialist provision of electronic Trial Master File (eTMF) technology and TMF services for the life sciences industry, and a top 10 major European pharmaceutical company have entered into a partnership for outsourcing TMF services.
As a result of this partnership, Phlexglobal will provide full eTMF services using the PhlexEview technology. The scope of the initial implementation is targeted for internal Pharma Company users across multiple trials, generating hundreds of thousands of pages of TMF content. The Pharma Company envisages a future global solution deployed across all their clinical trials, consolidating documents from strategic partners, other CROs, vendors and Pharma Company staff, to be accessed by thousands of worldwide users.
PhlexEview was implemented in a rapid 9 week period. The implementation includes managed study and user set up; a common TMF structure based on the TMF reference model version 3.0; multiple input and output steams and centralized reporting and oversight. Phlexglobal has also introduced recommendations for best TMF management practices as well providing expert resource to perform quarterly on-going TMF QC services.
This prompt start-up methodology employed for the implementation speaks to the level of TMF expertise provided by Phlexglobal as well as their ability to quickly assess client needs and translate them into a global solution.
Phlexglobal’s CEO, Rick Riegel: “There was a real proactive approach from Phlexglobal during the implementation phase. We’re looking forward to our partnership for the management and further development of our PhlexEview eTMF for this Sponsor. “
“We are excited to partner with this sponsor to provide PhlexEview as a full TMF management solution. PhlexEview will provide a global view in one common TMF structure, with CRO oversight metrics, as well as an electronic archiving solution in our e-archiving module PhlexEarchive,” said Karen Roy, senior vice president, client solutions.
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.