The graphic below was inspired by an MHRA presentation from 2018 by Andy Fisher.
Note: Phlexglobal customers already have this capability as part of the PhlexTMF eTMF software.
|Usual Industry Approach||PhlexTMF for Viewing Provides|
|TMF is often returned to sponsor on unsecure and hard-to-track media such as USB drives.||Fully compliant, secure, cloud-based storage|
Many documents still printed out - even if the CRO is using an eTMF
|Easy for sponsors to review at any time from anywhere|
|Difficult for sponsors to review||Facilitates streamlined access for inspectors, which has become an expectation among regulatory agencies|
|Sponsor documents are typically separate||Sponsor documents can be added directly to PhlexTMF for Viewing|
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