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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  • Regular QC to identify missing or outdated documents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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Testimonials

What our clients say about us

Recruiting Manager – Global Recruitment Firm
The number of interested candidates that want to join Tranquil is completely different than other CROs because of the way they value their employees.
Project Manager – Sponsor

The quality that Karim Mohammed, CEO and his company put in our project is something we have not experience by any other CRO.

VP of Operations – Sponsor

Quality Delivery of service every time.

Key Opinion Leader, Level I Children’s Hospital

Aj O. Senior CRA is the best CRA our site has ever had as a monitor.

Director of Operations – Sponsor

Tranquil Clinical Research has the best monitoring teams I have ever worked with.

Tina Smith

The Staff here is the best always makes me feel comfortable and treats me like family.

Roald Mark

Wonderful staff very clean well organized facilities and a special shout out to staff member Abraham Harmouch he is a very kind caring young man made me feel at ease explaining everything I needed to know.

Wonderful staff very clean well organized facilities and a special shout out to staff member Abraham Harmouch he is a very kind caring young man made me feel at ease explaining everything I needed to know.

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