30% of CROs offer an eTMF capability, and they report a broad range of benefits related to Audit and Inspection Readiness.
Most sponsors are comfortable with, and many prefer that, their CRO manage eTMF(s) in their system on their behalf.
There is a substantial market opportunity for CROs to become more competitive by becoming eTMF-enabled.
CROs report that most Requests for Proposals ask for an eTMF capability to be provided by potential CRO partners.
In today’s marketplace, electronic Trial Master File (eTMF) is viewed as a competitive differentiator for Contract Research Organizations (CROs).
eTMFs offer CROs the opportunity to:
Built on 20 years of TMF experience, Phlexglobal has a unique understanding of the industry’s TMF challenges and opportunities, and we partner with our clients to complement your capabilities with our expertise to deliver measurable results.
Our best-of-breed eTMF, PhlexEview, is optimally designed to very efficiently enable teams to work within the system, and flexible enough to support multiple client standards, conventions and TMF structures – key criteria for any CRO looking to select the right eTMF system and TMF partner.
Structure a commercial arrangement that offers predictable costs
Support your business development teams who can leverage Phlexglobal’s market leadership, name recognition, presentations, proposal content, and key differentiators to drive more business
Partner through every phase of an implementation to share our knowledge on how to support the broad range of industry expectations for paper and electronic TMF content management with accelerators, such as templates to capture Client Conventions
Manage multiple TMF structures to meet the varying filing needs of many clients, with the ability to apply study-specific logic to the default TMF structure easily
Provide highly configurable workflows and auto-assign activities and tasks to your staff based on priority
Report on the Completeness of an eTMF at any point in time
Facilitate TMF Quality Review
Offer site access for electronic Investigator Site File
Provide a cost-effective long term archiving solution for you or your sponsors
Phlexglobal provides a unique Trial Master File solution by leveraging dedicated and authoritative TMF technologies and expert services to bring order, stability, and control to your Trial Master File – helping you achieve the highest standards for completeness, timeliness, and quality.
UK: +44 (0) 1494 720420
US: +1 (484) 324-7921
E-Mail: info@phlexglobal.com
