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PhlexTMF for Viewing fills a gap in the trial master file life cycle
Few CROs offer compliant maintenance of the Trial Master File (TMF) following study closeout, often returning the eTMF on unsecured, hard-to-track media such as USB drives — or even printed out. As a result, TMFs can be difficult to review and inspect. Sponsors were forced to keep their own study documents separate, and they had limited options for regulatory compliance. Until now.
PhlexTMF for Viewing includes everything you need to successfully bring your TMF in-house:
PhlexTMF for Viewing includes everything you need to successfully bring your TMF in-house:
- Managed import of a CRO or third party’s eTMF documents, metadata, and audit trail
- Ability to oversee all interactions with the CRO or service provider
- Alignment with a third-party export format (spreadsheet, XML, CSV) and ability to handle all exceptions, such as passwords, encrypted files, zip files, non-eTMF content, attachments, and deleted documents
- Account creation, management, and training for sponsors and inspectors
- Maintenance of documents in an online system built for contextual TMF navigation with multi-attribute searching
- Simplified transition to long-term archive, when needed
Key benefits of PhlexTMF for Viewing
Migration
Includes everything required to transfer eTMF documents, metadata, and audit trail into PhlexTMF for Viewing.
Intuitive interface
Makes your TMF available for internal use and inspection in an intuitive user interface.
Ease of use
Designed for ease of navigation and inspection prior to final archiving.
Digital preservation
Enables easy transition from viewing mode to long-term digital preservation.
Advanced software
Powered by PhlexTMF advanced, purpose-built eTMF software.
Seamless, fully managed short- and mid-term TMF Storage
Usual industry approach:
- TMF is often returned to sponsor on unsecure and hard-to-track media such as USB drives.
- Many documents still printed out - even if the CRO is using an eTMF
- Difficult for sponsors to review
- Sponsor documents are typically separate
PhlexTMF for Viewing provides:
- Fully compliant, secure, cloud-based storage
- Easy for sponsors to review at any time from anywhere
- Facilitates streamlined access for inspectors, which has become an expectation among regulatory agencies
- Sponsor documents can be added directly to PhlexTMF for Viewing
Connect with our TMF experts to learn more
Get in touch to learn about how our solutions can help accelerate better health outcomes. Whether you have questions or just need more information, our experts are here to assist you.
At Cencora, we understand that effective Trial Master File (TMF) management is a cornerstone of successful clinical trial execution, regulatory inspection readiness, and long-term document governance. As a global provider of TMF services, we are fully committed to ensuring that all personal data processed within our TMF platforms and services complies with applicable privacy and data protection laws worldwide. TMF Solutions Global Privacy Statement