Skip Ribbon Commands
Skip to main content

Trial Master File

Requirements for a study’s trial master file are increasing. Part of an upcoming change is the demand for files being ‘readily available’ for inspection. NNIT can help you prepare for the changing standards and the increasing authority demands to ensure audit and inspection readiness.

​​​​​​​​​​Efficient clinical trials are a must and are a significant competitive factor in the process of bringing a product to market. As part of this, you have to ensure that all documentation associated with a particular study is well organized and accessible to investigators, sponsors and inspectors. 

NNIT can help you tackle the shift from directive to regulation and stay compliant. Call us today and learn more about our TMF consultancy. 

​​​Get more insight into Trial Master File by clicking on our latest webinars below:
 
 

 

 

Rasmus Koch Nelund+45 3079 6411rmne@nnit.com​​Vice Presidenthttps://www.linkedin.com/in/rasmusnelundRasmus Koch Nelund

 

 

Enhance TMF quality with scanning solutionhttps://www.nnit.com/OfferingsAndArticles/Pages/NNIT_Datasheet_Scanning_Solution_for_TMF.aspxEnhance TMF quality with scanning solution
Is your TMF inspection ready?https://www.nnit.com/OfferingsAndArticles/Pages/NNIT_Datasheet_Trial_Master_File.aspxIs your TMF inspection ready?
From directive to regulationhttps://www.nnit.com/OfferingsAndArticles/Pages/NNIT_article_TMF_from_directive_to_regulation.aspxFrom directive to regulation
How classic EDM hurdles will affect your eTMF implementationhttps://www.nnit.com/OfferingsAndArticles/Pages/NNIT_A4_EDM_Hurdles_UK_Article.aspxHow classic EDM hurdles will affect your eTMF implementation