Category: News

What is the Deal with Dataset-JSON?

Unpacking the Complexities of Clinical Data Submission Standards There is a storm brewing in the world of CDM (Clinical Data Management) and regulatory submissions. Since I came across the news that the FDA are considering Dataset-JSON as a new standard for submission I have conducted a lot of research to distil the wealth of information…
When do we know there is a problem to be solved?

Knowing When a Problem Should be Solved I have been pondering the question “When do we know there is a problem to be solved?”, for a while. Typically, we recognise there is a problem when we have unmet needs, there are inefficiencies in a process, we receive complaints or feedback, we notice tends in data,…
How do I extract clinical data from old systems?

Efficient Extraction of Clinical Data from Old Systems This article explores the challenge keeping clinical data in an old system and suggests various methods of extraction. Challenges of Old Systems Managing data in an old system presents several challenges that impact the efficiency and effectiveness of managing a clinical trial. Some of the key issues…

Partnership with Milient