ALCOA++ in Practice - A New Dimension of Data Quality

Can you trust your clinical data?
That question lies at the heart of every clinical trial — because patient safety and regulatory decisions depend on it.

In our latest article we turn to a well-known yet ever-evolving concept of what good quality data really means: ALCOA — and its modern extensions ALCOA+ and ALCOA++.

But ALCOA++ isn’t just a theoretical model or “best practice” anymore. It’s a regulatory expectation reflected across global guidelines such as:

• ICH E6(R3) Good Clinical Practice
• EU Annex 11
• FDA 21 CFR Part 11
• EMA Guideline on Computerised Systems and Electronic Data in Clinical Trials

For sponsors, CROs, and investigators, this means one thing: every electronic system must be validated, secure, and fully auditable. Only then can we ensure that clinical decisions are based on trustworthy, compliant, and verifiable data.

In our latest article, we break down ALCOA++ in practice - showing how each principle translates into real system and process requirements for EDC platforms and process workflows.

👉 Read more at GoResearch™.live blog: ALCOA++ in Practice – A New Dimension of Data Quality