PhlexTMF v23: Smarter TMF management with AI

Reduce repetitive quality work. Accelerate review. Strengthen confidence in inspection readiness.

PhlexTMF v23’s optional add-ons bring AI into everyday TMF workflows, with an estimated 20% efficiency gain from automated document corrections and selected cross-check reviews completed in half the time. 

Book a consultation

THE CHALLENGE

Routine TMF work is costing your team time it can't get back.

Much of the effort in TMF management is necessary, but it adds up quickly. That effort grows with every site, staff member, and supporting credential in a study.

Here's where it adds up:

  • Rotated pages, blank pages, and broken hyperlinks trigger avoidable corrections

  • Query resolution and resubmission can delay document approval

  • Cross-checking for required documents, versions, and gaps across records is resource-intensive

THE SOLUTION

Automate the corrections and cross-checks that slow you down.

PhlexTMF v23 applies AI-powered automation to selected TMF quality-control and completeness activities through two optional add-ons, built by TMF experts and backed by 26 years of experience. That means your team can focus more time on high-value work, while maintaining confidence in TMF quality.

Built into the workflow, not added around it, v23 includes:

  • Automated Document Remediation: Identifies and corrects certain document issues during QC, and flags patient identifiers and financial information to users.

  • AI-assisted Cross-checking: Uses information in one document to determine whether other required documents are present and accurate.

20%

estimated efficiency gain

15 min

saved per document correction

50%

faster selected cross-check reviews

AUTOMATED DOCUMENT REMEDIATION

Phlexglobal v23 - Automated Document Remediation Screen

Resolve common document issues before they lead to resubmission.

Quality issues are surfaced within the document QC workflow, and certain issues can be corrected without requiring user action.

  • Page rotation: Corrected automatically, without manual rework

  • Blank pages: Removed automatically during QC

  • Hyperlinks: Broken links corrected before they hold up approval

  • Patient Identifiers & Financial Information: Identified, with users informed of resulting actions

Less correction, query resolution, and resubmission work can improve processing efficiency and help prevent delays in document approval.

EXAMPLE IMPACT

With 5,000 documents a month, avoiding 150 resubmissions could add up to about 4.5 working days of time savings.

37 Hours

saved each month

AI-ASSISTED CROSS-CHECKING

Find gaps across related records in less time.

Cross-checking confirms that a TMF contains the right documents, in the right versions, with nothing missing between related records. It's essential work, and it becomes more demanding as studies grow.

v23 takes a smarter approach by using the information already captured in one document to check for the other documents that should accompany it.

PhlexTMF v23 - Site Personnel

Site Personnel Matching

Confirm credentials are on file for listed personnel

  • Start from an FDA Form 1572 or delegation log

  • Extract personnel names from digital and handwritten documents

  • Search for associated CVs, medical licenses, GxP certificates, contracts, and data privacy agreements

PhlexTMF v23 - Monitoring Reports

Monitoring Visit Reports

Match logged visits to their required documents

  • Start from a site's monitoring visit report log

  • Extract visit dates automatically

  • Check for the required confirmation letter, visit report, and follow-up letter

  • Create and link the corresponding events

EXAMPLE IMPACT

At about 30 minutes saved per site per quarterly review, the potential savings grow with every site in your study: 

Study Profile Est. Annual Time Saving
Small Study (10 Sites) ~20 Hours
Mid-sized Study (50 Sites) ~12.5 Working Days
Large Study (150 Sites) ~7.5 Working Weeks

Measurable gains for your TMF team.

Reduce
Manual Effort

Automate avoidable correction and resubmission work.

Keep Approvals Moving

Help prevent delays by cutting down on corrections and query resolution.

Accelerate Quality Activities Readiness

Complete selected review and completeness checks faster, with savings that grow as study size increases.

Build Inspection Confidence

Identify missing or inconsistent documentation more efficiently.

Phlexglobal Website Backgrounds_Dots v1

See what v23 could save your team.

Every study is different. Speak with our TMF experts to assess the potential impact of automated remediation and AI-assisted cross-checking on your TMF operations and quality review processes.

Start the conversation

TMF Expertise In Action

Connect with Phlexglobal experts and stay up-to-date on the latest pharmaceutical, biotech and medical device industry trends.

CDISC US 2026 Round-up: Where TMF Is Headed Next

The TMF community recently came together in Denver for the CDISC US Interchange, and members of the Phlexglobal team came home with plenty to reflect on. Across sessions, hallway discussions, and

Trial Master File Management: The Next Generation

CDISC US was a great opportunity to meet customers, colleagues, and fellow industry experts face to face – both for the first time and re-connecting after a year or more away. There was a fantastic

TMF Standard Model V1 Transition: Preparing for Change

When my Trial Master File (TMF) career began, the TMF Reference Model did not exist. Every customer had a different way of organising the contents of their TMF, and it was rarely interpreted