Know what needs attention in your TMF—and why

We provide independent TMF reviews, with prioritized findings and recommended actions. VCS Surveyor™, our AI-powered TMF software, ingests every document you provide, not a sample. Our experts evaluate flagged items and determine the findings. Faster than a manual review, with broader document coverage.

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You provideYour TMF records
VCS reviewReviewer judgment, empowered by VCS Surveyor™
You receiveA TMF Review Report with prioritized findings and recommended actions
The resultKnow where your TMF stands, and what to fix next

At every stage of your study

Catch gaps while they are still easy to fix

Missing records are easiest to recover while sites and study staff are still active, not after the study is over.

You receiveA report for each review that alerts you to hidden issues and assesses prior corrective actions.

Close out or transfer with a clear remediation list

See what remains open before you sign off or accept a TMF transfer, and fix it while the team is still in place.

You receiveA report: the gaps that remain and a remediation list to close them.

Archive a TMF you can stand behind

Confirm your team completed any corrective and preventive actions (CAPA), and fix what is left before archiving.

You receiveA report documenting which planned remediation steps are complete, with supporting evidence and any remaining issues.

What matters to TMF owners

CompletenessVCS Surveyor™ processes the supplied documents and applies checks according to the document type and available information
AssuranceUnderstand what action is needed to address your GCP obligations
IndependenceAn outside, objective review
SpeedAnswers sooner than manual review
EfficiencyAI does the heavy lifting
Cost-effectivenessFocus your resources on the findings that matter most

Empower your team to complete its mission, efficiently

PrioritizeFindings are prioritized so your team can address what matters first
ActEach finding comes with its evidence and a recommended action
Stay on missionWe carry out the review; your team keeps the study moving
Keep controlYour records stay unchanged

You receive the report, a findings list and a walkthrough, written and approved by VCS experts.

Backed by clinical quality, inspection and trial methodology experience. Meet the team

Example: from a signal to a finding

Using the expectations agreed for the review, VCS Surveyor™ checks each site’s records for expected essential documents and shows our reviewer what appears to be missing and where to look.

Signal: no monitoring visit report for site 2002 Reviewer checks the site’s records Conclusion

A VCS Surveyor™ review item, Milestone Completeness, Tier 1, open: a Monitoring Visit Report is required for site 2002 at a monitoring visit the sponsor marked as done, but no document of that type is in the TMF. The panel explains why VCS Surveyor™ is showing it, what to do and where to look, cites ICH E6(R3) Annex 1 §C.3.2, and sits next to the reviewer's decision controls. — Output from VCS Surveyor™: the item it flagged, why, and where our reviewer should look. Shown on a synthetic test study with invented sites and documents. A flag is not yet a finding; our reviewer decides.

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Let’s discuss your priorities.

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