Our Views Articles, views and insights from the ADAMAS team. MHRA Critical Definition Change 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... Changing Landscape of TMF Management Part 2 Having a TMF entirely on paper, stored in filing cabinets (even the fancy compactors), is now thought to be unsustainable. Many companies are... Changing Landscape of TMF Management Part 1 A Trial Master File (TMF) is the collection of documentation that allows the conduct of the clinical trial, verification of the integrity of... Clinical Research Tribulations: India India, with its large disease burden and experienced medical professionals, has been actively contributing to the global drug development, for more than a... Reflections on the Trial Master File The deadline for industry comment on the EMA draft reflection paper on GCP compliance in relation to trial master files (paper and/or electronic)... To Be or Not to Be Present; the Monitor as a Translator As I start to write this blog I have to admit this is not a topic in which I consider myself an expert.... Load More Loading More... You’ve reached the end of the list
MHRA Critical Definition Change 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...
Changing Landscape of TMF Management Part 2 Having a TMF entirely on paper, stored in filing cabinets (even the fancy compactors), is now thought to be unsustainable. Many companies are...
Changing Landscape of TMF Management Part 1 A Trial Master File (TMF) is the collection of documentation that allows the conduct of the clinical trial, verification of the integrity of...
Clinical Research Tribulations: India India, with its large disease burden and experienced medical professionals, has been actively contributing to the global drug development, for more than a...
Reflections on the Trial Master File The deadline for industry comment on the EMA draft reflection paper on GCP compliance in relation to trial master files (paper and/or electronic)...
To Be or Not to Be Present; the Monitor as a Translator As I start to write this blog I have to admit this is not a topic in which I consider myself an expert....
