How Global Clinical Trial Regulations Impact Healthcare Technology

By Taylor Davidson, Florence

When searching for clinical trial software, every site, sponsor and CRO has the same question: “how does this software comply with (insert clinical trial regulation here)?” 

Research professionals face an overwhelming number of regulations. In addition to international guidelines like ICH Good Clinical Practice, the Global Data Privacy Regulation (GDPR), or the EU Clinical Trials Regulation, they must also navigate the labyrinths of laws within individual countries. 

We collaborated with WCG, a leader in global compliance, to explore the clinical trial regulations in 22 countries–with more to come. Then we compiled a list of compliance questions you should ask when looking for clinical trial software: 

• Which elements of compliance is the software vendor responsible for, and which parts am I responsible for?
• How does the software vendor comply with regulations focused on electronic documents, like FDA 21 CFR Part 11 and EU Annex 11? 
• What specific functions am I looking for from my technology, and how do regulations impact each of them? 
• Will the software vendor work with me to ensure I can meet the individual requirements of my country? 

In this article, we’ll tackle how Florence’s compliance team approaches each of the above questions to help our customers with clinical trial regulations.