Concept Papers

Guidance Docs
1 Introduction Conducting a clinical trial is a complicated process because of the many factors to address and the numerous entities involved. One...
Guidance Docs
1 Introduction Contemporary communications technologies, particularly those relating to the internet, have the potential to revolutionize...
Guidance Docs
1 Introduction In the evolving regulated IT environment there are many things to consider when thinking of turning to the cloud for a solution. This...
Guidance Docs
1 Introduction What should be planned for when implementing a new computerized system, such as a clinical trial database? For clinical computerized...
Guidance Docs
1 Introduction ASTM defines process capability as the natural or inherent behavior of a stable process that is in a state of statistical control,...
Guidance Docs
1 Introduction Over the past decade, the life sciences industry has seen cloud-based services and solutions evolve from a misunderstood technology...
Guidance Docs
1 Introduction In the evolving regulated IT environment there are many things to consider when thinking of turning to the cloud for a solution. Using...
Guidance Docs
Data integrity is a global expectation as evidenced by the Medicines and Healthcare Products Regulatory Agency (MHRA) guidance, published in January...
Guidance Docs
1 The Need for Access Point to any country on a map of the world. That’s where you might find a patient in urgent need of a new therapeutic option....
Guidance Docs
1 Introduction It is well understood that each clinical trial is conducted and managed as an independent project even if several trials investigate...