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, PhlexTMF, 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.
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.
Downlad the new infographic, “5 Reasons Why CROs Are Choosing Phlexglobal’s eTMF” to get more details around the reasons CROs and AROs are turning to Phlexglobal, such as:
The term audit trail can be daunting for companies, but this is a regulatory requirement. Simply put, when it comes to the trial master file (TMF), if an action is not recorded in the audit trail,
We are thrilled to announce Season 2 of our exciting webinar program, Summer Shorts: TMF Excellence Edition! Avoid boring summer reruns and attend these fresh, informative sessions where our experts
Close-out of a clinical trial raises many questions about responsibility and management of the trial master file (TMF). According to ICH E6 (R2), final close-out can only occur when the monitor – or
UK: +44 (0) 1494 720420
US: +1 (484) 324-7921
Poland: +48 81 45 46 132
Germany: +49 89 23514741
E-Mail: info@phlexglobal.com