Trial Master File

At Tranquil Clinical Research, our team will ensure your essential documents are well completed and filed according to the requirements of the FDA and local regulations.

Trial Master File

We work with investigative sites to ensure compliance throughout the study period. Tranquil Clinical Research has robust quality assurance steps to ensure an accurate and complete trial master file including:

  • Investigative site training on document maintenance expectations
  • On-site and/or remote review of Investigator Site File
  • Regular QC to identify missing or outdated documents
  • Review to ensure compliance with ALCOAC standards
  • Tracking and follow-up of issues and implementation of deadlines for resolution
  • Full analysis of TMF at study close for compliance and completeness

Tranquil Clinical Research is in the business of innovation, servicing sponsors, patients and clients through clinical trials.


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