PhlexTMF for Viewing

PhlexTMF for Viewing is a cloud-based Trial Master File (TMF) storage solution from Phlexglobal, designed for clinical trial sponsors who need compliant, inspectable access to their TMF after a CRO returns it at study closeout. It addresses a recognised gap in the TMF lifecycle: the period between a CRO returning the final eTMF and the sponsor completing long-term archiving, during which documents are often held on unsecure media such as USB drives or in printed form.

The product is built on PhlexTMF, Phlexglobal's purpose-built eTMF software platform. It is intended for closed or locked studies and is positioned as a mid-term storage option prior to final digital preservation. Existing Phlexglobal customers already have this capability within their standard PhlexTMF subscription.

Key Benefits

• Provides fully compliant, secure, cloud-based storage for closed and locked study TMFs.
• Makes the TMF available for internal review and regulatory inspection through an intuitive user interface.
• Designed for ease of navigation and inspection prior to final archiving.
• Supports easy transition from Viewing Mode to long-term digital preservation when required.
• Allows sponsor documents to be added directly into the system, consolidating previously separate sponsor and CRO records.
• Facilitates streamlined inspector access, which regulatory agencies increasingly expect.

How PhlexTMF for Viewing Compares to Typical Industry Practice

• TMFs are commonly returned to sponsors on unsecure, hard-to-track media such as USB drives; PhlexTMF for Viewing provides cloud-based, compliant storage instead.
• Many documents are still returned in printed form even when a CRO uses an eTMF; PhlexTMF for Viewing makes documents accessible for review at any time from any location.
• Sponsor documents are typically held separately from CRO-managed TMF content; PhlexTMF for Viewing allows sponsor documents to be added directly to the same system.
• Reviewing and inspecting documents returned on physical media is difficult; PhlexTMF for Viewing supports streamlined inspector access aligned with regulatory expectations.

Managed Import and Setup Services

• Managed import of eTMF documents, metadata, and audit trail from the CRO or third-party provider into PhlexTMF for Viewing.
• Phlexglobal oversees all interactions with the CRO or service provider during the transfer process.
• Alignment with the third party's export format, including Excel, XML, and CSV, with handling of exceptions such as passwords, encryption, zip files, non-eTMF content, attachments, and deleted documents.
• Account creation, user 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 the sponsor is ready to proceed.

PhlexTMF for Viewing is delivered as a fully managed service, with Phlexglobal handling the technical and operational aspects of the TMF transfer and ongoing storage. It is suitable for sponsors with CRO-managed studies approaching or past the point of study closeout who require inspection-ready access to their TMF without maintaining a full eTMF platform.