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Trial Master Files: Getting Them Right The First Time, Every Time

 
• By Amy Cheung, Al Ow, and Jenny Ahn

Trial Master Files provide evidence that sponsors complied with regulations and protected the rights and safety of clinical trial participants. Pharmaceutical firms can save time and money by building a TMF process that ensures they get it right from day one.

The Trial Master File (TMF) is the primary source of clinical trial documentation. It provides evidence that patient rights and safety were protected throughout the trial and that the integrity of the trial data, study analysis and study conclusions are credible. The TMF also demonstrates that trial sponsors complied with applicable regulatory requirements, which have become more stringent in recent years.

According to the US Food and Drug Administration, the number of FDA issued Form 483s

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Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Eleanor Malone

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Early Development Deals: Ipsen's Strategy For Biomarker-Driven Success

 
• By Eliza Slawther

Mary Jane Hinrichs, Ipsen’s head of early development, talks to In Vivo about getting ahead of the competition by securing deals for candidates before they enter Phase I trials.   

Shape Our Content: Take The Reader Survey

 
• By Eleanor Malone

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access In Vivo, or if you love it how it is, now is the time to have your voice heard.

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Prioritizing Safety in CAR-T Therapy: Patient Monitoring with Cerba Research’s Testing Portfolio

The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.

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Podcast: Tevard CEO Sees Hope For His Daughter In Company’s tRNA Platform

 
• By David Wild

Tevard Biosciences CEO Daniel Fischer discusses how engineered suppressor tRNAs overcome nonsense mutations, restoring full-length protein production to treat rare genetic diseases like Dravet syndrome.

Deals In Depth: July 2025

 
• By Deanna Kamienski and Maureen Riordan

Six $1bn+ alliances were penned in July, and two exceeded $2bn.

Execs On The Move: July 2025

 
• By In Vivo Team

An interactive look at recent executive-level company changes and promotions in the biopharma, medical device and diagnostics industries.