The Four Pillars of Credible Digital Trials

Digital transformation is driving new possibilities in clinical trials — enabling remote participation, real-time data analysis, and smarter decision-making. But as technology becomes integral to research, the industry faces a growing responsibility: ensuring that every digital tool used in a study meets the highest standards of data quality and security.

In our latest article at GoResearch™.live blog , we take a closer look at the four pillars of trustworthy digital trials: integrity, security, validation, and qualification. You’ll learn how these elements work together to ensure that electronic data is accurate, traceable, and compliant with regulatory expectations.

The article discusses how the future of clinical trials depends on balancing innovation with integrity. It explains why computer system validation, supplier qualification, and data security must form the backbone of every digital trial. Regulations such as ICH E6 (R3) GCP, EU Annex 11, and FDA 21 CFR Part 11 provide guidance — but their successful application requires a deep understanding of both technology and compliance.

The text also explores the shared responsibility model:

• Sponsors - ensuring system validation and vendor oversight,
• Investigators - guaranteeing data accuracy at the site level,
• Service providers - maintaining security, documentation, and change control.

Together, these elements safeguard not only data but also patient safety and the integrity of scientific results.

👉 You can find the full article here: Trustworthy technologies – how to ensure the credibility of clinical trials in the digital era?