Our Views Articles, views and insights from the ADAMAS team. Events View all events Resources Explore all resources MHRA Critical Definition Change Date September 25, 2014 On 25-Apr-14, the MHRA issued a press release indicating that the definition of a critical GCP inspection finding had been changed. It now... Read More Changing Landscape of TMF Management Part 2 Date September 2, 2014 Having a TMF entirely on paper, stored in filing cabinets (even the fancy compactors), is now thought to be unsustainable. Many companies are... Read More Changing Landscape of TMF Management Part 1 Date August 15, 2014 A Trial Master File (TMF) is the collection of documentation that allows the conduct of the clinical trial, verification of the integrity of... Read More Clinical Research Tribulations: India Date July 18, 2014 India, with its large disease burden and experienced medical professionals, has been actively contributing to the global drug development, for more than a... Read More Reflections on the Trial Master File Date May 15, 2014 The deadline for industry comment on the EMA draft reflection paper on GCP compliance in relation to trial master files (paper and/or electronic)... Read More To Be or Not to Be Present; the Monitor as a Translator Date April 16, 2014 As I start to write this blog I have to admit this is not a topic in which I consider myself an expert.... Read More Load More Loading More... You’ve reached the end of the list
MHRA Critical Definition Change Date September 25, 2014 On 25-Apr-14, the MHRA issued a press release indicating that the definition of a critical GCP inspection finding had been changed. It now... Read More
Changing Landscape of TMF Management Part 2 Date September 2, 2014 Having a TMF entirely on paper, stored in filing cabinets (even the fancy compactors), is now thought to be unsustainable. Many companies are... Read More
Changing Landscape of TMF Management Part 1 Date August 15, 2014 A Trial Master File (TMF) is the collection of documentation that allows the conduct of the clinical trial, verification of the integrity of... Read More
Clinical Research Tribulations: India Date July 18, 2014 India, with its large disease burden and experienced medical professionals, has been actively contributing to the global drug development, for more than a... Read More
Reflections on the Trial Master File Date May 15, 2014 The deadline for industry comment on the EMA draft reflection paper on GCP compliance in relation to trial master files (paper and/or electronic)... Read More
To Be or Not to Be Present; the Monitor as a Translator Date April 16, 2014 As I start to write this blog I have to admit this is not a topic in which I consider myself an expert.... Read More
