How Can Sponsors Determine Their ICH E6(R3) Risk Profile for Biospecimens?

The clinical research landscape is evolving — and so are the expectations placed on sponsors. With ICH E6(R3) guidelines being enforced in the EU starting July 23rd, sponsors are facing a pivotal moment: evaluate their process gaps or risk falling out of compliance.

And one area that is now explicitly in the spotlight? Biospecimen management. For the first time, biospecimens are recognized not just as physical samples, but as essential records — on par with clinical data. In the eyes of regulators, biospecimens = data.

If you’re a sponsor supporting biospecimen operations, this shift should raise an important question: How exposed are we under ICH E6(R3)?

What’s new in ICH E6(R3)?

ICH E6(R3) introduces several important changes that reshape what quality, data governance, and oversight expectations look like — especially for sponsors who deal with biospecimens. Here are some of the key updates:

• Risk-Based Quality Management (RBQM) is no longer optional. Sponsors are expected to embed a risk-based approach across the biospecimen lifecycle.
• Computerized systems and data governance are front and center. You must demonstrate control over digital systems used to manage clinical trial data — including those used for biospecimen tracking. This means ensuring that documented procedures are in place for sample metadata collection, handling, and management. Computerized systems are also expected to be validated as fit for purpose for use in the trial.
• Expanded sponsor responsibilities mean more accountability. Sponsors must oversee quality, traceability, fit-for-purpose evaluation, and validation for all of the systems and processes that support their biospecimen operations.
• Stronger requirements for data traceability and integrity. Sample metadata must be accurate, complete, and retrievable at any point in the trial — creating added scrutiny around chain of custody, audit trails, and documentation.

Whether you work in large pharma or at a small biotech, you still must also ensure that your systems and processes are compliant before July — especially if you’re managing biospecimens on global and EU-based trials. 

Why biospecimen management is high-risk under ICH E6(R3)

Biospecimens play a crucial role in today’s complex, data-driven trials. They are directly tied to trial endpoints, exploratory biomarker research, patient stratification, and even regulatory submission data. That’s why they’re now considered essential data — and why biospecimen mismanagement is a top compliance risk.

Here are a few of the most common biospecimen management risks that could trigger findings under ICH E6(R3):

• Breakdowns in chain of custody
• Data integrity issues (missing, inaccurate, or mismatched sample metadata)
• Process deviations that go untracked or unreported until it’s too late
• Delayed or siloed access to data across the biospecimen lifecycle
• Inadequate documentation of the full biospecimen audit trail

Any one of these issues could lead to:

• Regulatory inspection findings
• Exclusion of data from analysis or submission
• Trial delays and increased costs
• Reputational harm and loss of stakeholder confidence

With so much at stake, sponsors can no longer afford to treat biospecimen management as an afterthought.

Key questions sponsors should ask to assess their risk profile

So how do you know whether your organization is at risk? Start by asking these practical, high-stakes questions:

• Do we have a risk-based quality management plan that explicitly covers the entire biospecimen lifecycle — from collection to analysis?
• Are our SOPs and documentation practices aligned with the new ICH E6(R3) standards?
• How reliable and robust are our data governance and tracking systems for biospecimens?
• Are roles and responsibilities clearly defined, documented, and followed — both internally and with vendors?
• Do we have mechanisms in place to monitor, detect, and respond to biospecimen risks in a timely manner?

If any of these questions give you pause, you’re not alone — and you’re not out of options. A focused gap analysis can help you pinpoint your organization’s vulnerabilities before regulators do.

Steps to strengthen your ICH E6(R3) compliance

To mitigate your risk and ensure ICH E6(R3) readiness, here are some steps sponsors can take right now:

1. Complete a self-assessment focused on biospecimen operations. Start by identifying where your processes and systems fall short of new expectations.
2. Update your SOPs and risk management plans to align with the full biospecimen lifecycle and ICH E6(R3)’s new requirements.
3. Train your teams — including internal stakeholders, sites, and vendors — on the revised guidelines and best practices for biospecimen compliance.
4. Leverage technology solutions and expert services that increase sample visibility, centralize oversight, and improve quality across the biospecimen lifecycle.

With the right systems and guidance in place, you can turn biospecimen management from a compliance risk into a competitive advantage.

Take action: Know your risk, protect your trial

ICH E6(R3) marks a turning point for sponsors. The organizations that invest in proactive compliance today will be the ones best positioned for inspection readiness, data integrity, and long-term success.

Don’t wait until your next regulatory inspection to find out where you stand. Take control now.

Ready to find out where you stand?

Watch our on-demand webinar, "The Impact of ICH E6(R3) on Biospecimen Management", featuring expert insights into how these regulatory changes affect biospecimen operations — and what you can do to stay ahead.

Complete our self-assessment to quickly evaluate your organization’s ICH E6(R3) compliance risk for biospecimen management.