What happens if we don’t validate?

Since July 2025, data governance has become a central focus in clinical operations and clinical trials. The updated ICH-GCP E6(R3) guidelines have raised expectations for sponsors and CROs — especially when it comes to validation and oversight of computerized systems used in GxP-regulated activities.

Stronger Expectations for Compliance
Today, sponsors and CROs must prove that their data is traceable, secure, and accurate, supported by documented evidence. Regulators expect visible, structured data governance. As digital and decentralized trials expand, the need for tighter control and collaboration between functions continues to grow.

What Data Governance Really Means
Effective data governance defines who owns the data, how it’s protected and used, and what controls ensure compliance. This is essential across GxP environments, cloud-based systems, and studies using patient-reported outcomes (ePRO).

Why Validation Matters
Data integrity and data quality are not the same — but one cannot exist without the other. Integrity ensures data is real, traceable, and protected; quality depends on it.

When integrity is lost, so is trust. Inaccurate or incomplete data can lead to incorrect conclusions — and in clinical trials, that means potential risks to patient safety.

Shared Responsibility
Both QA and IT play key roles in safeguarding data integrity. Sponsors must also ensure that service providers such as EDC or ePRO vendors use validated systems with proper controls, and that system use is clearly documented. 

A validation statement alone is not enough — regulators expect demonstrable proof that systems truly protect data.

The True Risk of Weak Governance
A trial can fail not because of an error, but because there’s no documented assurance that data integrity was maintained.
That’s the real risk: loss of confidence, credibility, and compliance.

How PharmaRelations Can Help
At PharmaRelations, we support Life Science companies in building trust through compliance.

Our experts in GxP validation, QA, and data governance help you establish robust frameworks, validate systems, and prepare for audits or inspections — ensuring your data is accurate, traceable, and compliant.

Whether you need interim expertise, project-based validation, or long-term QA partnership, we can help your organization meet the demands of ICH-GCP E6(R3) and beyond.

📩 Get get in touch with us to discuss how we can help you strengthen data integrity and compliance in your clinical operations.