ISO/IEC 27001:2022 in Clinical Trials

Turning Data Security into a Quality Standard

In clinical trials data security extends far beyond IT controls, encompassing governance, processes, and human factors that collectively safeguard patient rights and research integrity.

ISO/IEC 27001:2022 offers a structured, risk-based framework that enables organizations to operationalize regulatory expectations set by GCP, ICH E6 (R3), Annex 11, and 21 CFR Part 11. Its Annex A controls span organizational, people-related, physical, and technological domains - all of which are directly relevant to EDC systems and other tools used in clinical trials.

In our latest article, we explore how these controls can be applied in practice to:

• strengthen data integrity and audit readiness
• manage human and vendor-related risks
• support compliance in global, cloud-based trial environments

To see how ISO/IEC 27001:2022 turns data security into a measurable quality standard in clinical trials, read the full article at GoResearch™.live blog:

👉 ISO/IEC 27001:2022 in Clinical Trials: Turning Data Security into a Quality Standard .