ICH E6(R3) Impacts Your Biospecimen Operations: Why Sponsors Must Act Now

Clinical research is entering a new regulatory era with the transition from ICH E6(R2) to ICH E6(R3). While the industry has long anticipated updates to Good Clinical Practice (GCP) guidelines, many sponsors may not yet realize the profound impact these changes will have — especially on biospecimen management.

For sponsors supporting critical functions like clinical operations, biospecimen operations, translational medicine, and data management, the heightened expectations around risk-based quality management, data governance, and oversight introduce a level of scrutiny that demands immediate attention. On July 23rd, 2025, the European Medicines Agency (EMA) will become the first major regulatory body to officially adopt ICH E6(R3), directly impacting every trial with operations in the EU. 

What does this mean for your biospecimen management processes? How do these new expectations translate into day-to-day operations? And what steps can you take today to ensure compliance and mitigate risk?

The new reality: Biospecimens are data

One of the most pivotal shifts in ICH E6(R3) is the explicit recognition of biospecimens as regulated data. Historically, many sponsors have viewed biospecimen management as a logistical function separate from broader data governance policies. However, under ICH E6(R3), biospecimens are classified as essential records — placing them under the same risk-based quality and data integrity requirements as other forms of clinical trial data.

This means that if your organization is already implementing risk-based monitoring and data governance strategies for other forms of study data, you must extend these principles to biospecimens. Failure to do so could result in noncompliance, operational inefficiencies, and increased regulatory risk.

Want to dive deeper into the specific ICH E6(R3) language that impacts biospecimen management? Sign up for our live webinar, “The Impact of ICH E6(R3) on Biospecimen Management”, to learn more about how to interpret the updated guidelines and discover how to assess compliance ahead of the EMA's July implementation deadline.

Risk-based quality management: The new standard

ICH E6(R3) mandates that sponsors implement risk-based quality management (RBQM) frameworks that extend beyond traditional data oversight. Given that biospecimen management is a critical activity given the value patient samples provide, and given the level of risk that is inherent in today’s trials, biospecimens must be prioritized even higher now in risk-based quality systems.

Sponsors can no longer rely on fragmented, manual tracking systems that are not conducive to proactive risk intervention or do not offer end-to-end visibility of the sample journey — such as Excel spreadsheets. The expectation is clear: Sponsors must proactively identify and mitigate risks across every stage of the biospecimen lifecycle — including collection, processing, storage, and shipping.

Data governance: Spreadsheets are no longer sufficient

ICH E6(R3) reinforces the necessity of robust data governance strategies around computerized systems. A major implication of this is the requirement for data validation, reproducibility, and security across all clinical trial data — including biospecimens.

For many sponsors, this raises a critical question: Can your current biospecimen management system ensure regulatory compliance? If you are still relying on spreadsheets or disparate tracking methods, the answer is likely no. Regulatory authorities now expect the digital systems that sponsors use to be fit-for-purpose, validated, and supported by robust documentation. 

Sponsor oversight: Strengthening accountability in biospecimen management

Another key change in ICH E6(R3) is the reinforcement of sponsor oversight responsibilities. While sponsors have always been ultimately accountable for trial compliance, the new guidance clarifies that they cannot rely solely on third-party vendors, CROs, or research sites to manage biospecimens.

Even if you have outsourced biospecimen logistics to a CRO or central lab, your organization is still responsible for ensuring compliance with ICH E6(R3). This means having clear oversight mechanisms, documentation, and enhanced visibility to your biospecimens.

The risk of inaction

With the EMA’s July 2025 implementation deadline rapidly approaching, sponsors must act now. While regulatory enforcement may not be immediate, the longer organizations delay alignment with ICH E6(R3), the greater the compliance risk.

Failure to adapt could eventually result in:

• Increased audit findings and regulatory scrutiny
• Data integrity concerns that impact trial outcomes
• Delays in study timelines due to noncompliant biospecimen management practices
• Financial and reputational consequences from failed inspections

Learn from industry experts

Understanding the nuances of ICH E6(R3) is critical to ensuring compliance and optimizing biospecimen management strategies. That’s why we’re bringing together industry experts to break down these regulatory changes and provide actionable insights.

Join our live webinar, "The Impact of ICH E6(R3) on Biospecimen Management", where thought leaders — including legal and regulatory experts — will discuss:

• The specific ICH E6(R3) updates affecting biospecimen operations
• How to proactively align biospecimen management practices with new regulatory expectations
• Introduce a framework for assessing compliance ahead of the EMA’s July deadline

Register now to ensure your organization is prepared.