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Chief Medical Officer Summit -CMO 360°
Meet the Veristat team at Booth #3, April 17th and 18th in Boston
The Science-First CRO™ and Consultancy Ready to...
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Veristat held its first Lunch & Learn session of 2015 on February 23rd. Lunch & Learn sessions provide every employee with the opportunity to learn about important aspects of departments that their work has an impact on, but that they may not interact with directly on a regular basis. These sessions enhance Veristat's ability to work as a cohesive team, instead of as six separate functional departments. The topic of the first session was Trial Master Files.
A trial master file is a collection of the important content for clinical trials that are overseen by a regulatory agency. The content that makes up a TMF may vary by country. The United States Food and Drug Administration requires clinical trials to be in compliance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. These guidelines provide a list of the minimum requirements for a TMF. A comprehensive list was developed by members of the Drug Information Association (DIA) to reduce inconsistencies across the industry. Veristat uses the DIA TMF method.
The DIA TMF Reference Model provides an opportunity for standardization across the industry, and can be used by any company in an electronic or paper form. The model is broken down into 11 zones:
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Apr 9, 2024 Veristat Events
Meet the Veristat team at Booth #3, April 17th and 18th in Boston
The Science-First CRO™ and Consultancy Ready to...
4 min read
Mar 22, 2024 Veristat Events
Don´t miss Veristat’s plenary presentation at the World Orphan Drug Congress (WODC), Boston, Thursday, April 25th at...