PhlexTMF for Viewing

Inspectable Mid-Term TMF Storage for Closed or Locked Studies from Your CRO

PhlexTMF for Viewing Fills a Gap in the Trial Master File Lifecycle

Few CROs offer compliant maintenance of the Trial Master File following study close closeout, usually returning the eTMF on unsecure and hard-to-track media such as USB drives or even printed out. These Trial Master Files are difficult to review and inspect, and force sponsors to keep their own study documents separate. Sponsors had limited options for compliance with regulatory requirements – until now. The graphic below was inspired by an MHRA presentation from 2018 by Andy Fisher.

PhlexTMF for Viewing answers that pressing need with secure, compliant, cloud-based TMF storage for closed and locked studies.PhlexTMF for Viewing Compliance Gap

Note: Phlexglobal customers already have this capability as part of the PhlexTMF eTMF software.

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The TMF Compliance Gap can be a real problem.

Watch this short video to learn why and how PhlexTMF for Viewing can help. 

PhlexTMF for Viewing Explainer Video_Crossing the Compliance Gap 2021
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Key Benefits of PhlexTMF for Viewing

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Includes everything required to transfer eTMF documents, metadata, and audit trail into PhlexTMF for Viewing

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Makes your TMF available for internal use and inspection in an intuitive user interface

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Designed for ease of navigation and inspection prior to final archiving via PhlexArchive or your selected destination

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Enables easy transition from Viewing Mode to long-term digital preservation

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Powered by PhlexTMF advanced, purpose-built eTMF software

Watch this On Demand Webinar to see how

PhlexTMF for Viewing can help you cross the Compliance Gap

PhlexTMF for Viewing On Demand

Crossing the TMF Compliance Gap with Inspection-Ready Access for Closed Studies

In this session, we explore an innovative new way to ensure your TMF stays secure while remaining accessible to audits and inspectors so you can focus on getting your drug to market and not on finding documents.  

 

On Demand

 

Seamless, fully managed short- and

mid-Term TMF Storage

Every study needs to meet these requirements.

PhlexTMF for Viewing provides a better solution.

Usual Industry Approach   PhlexTMF for Viewing Provides
TMF is often returned to sponsor on unsecure and hard-to-track media such as USB drives. Arrow Fully compliant, secure, cloud-based storage

Many documents still printed out - even if the CRO is using an eTMF

Arrow Easy for sponsors to review at any time from anywhere
Difficult for sponsors to review Arrow Facilitates streamlined access for inspectors, which has become an expectation among regulatory agencies 
Sponsor documents are typically separate Arrow Sponsor documents can be added directly to PhlexTMF for Viewing

 

Request a Consultation

 

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Do you have a CRO-Managed Trial Master File Nearing the Compliance Gap?

Phlexglobal is Ready to Help!

 

PhlexTMF for Viewing includes everything you need to successfully bring your TMF in house

  • Managed import of CRO or third party’s eTMF documents, metadata and audit trail into PhlexTMF for Viewing
  • Oversee all interactions with the CRO or service provider
  • Alignment with third party’s export format (excel, xml, csv) and handle all exceptions such as passwords, encryption, zips, non-eTMF content, attachments, deleted documents etc
  • Account creation, management, and training for sponsors and inspectors
  • Maintenance of documents in anon-line system built for contextual TMF navigation with multi-attribute searching
  • Simplified transition to long-term archive when needed
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Get the details

Download the PhlexTMF for Viewing Data Sheet

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It's time to raise your standard 

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